Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT04584294
Status:
COMPLETED
Last Update Posted:
2025-11-06
First Post:
2020-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient-Centered Reproductive Decision Support Tool for Women Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003268', 'term': 'Contraception Behavior'}], 'ancestors': [{'id': 'D043762', 'term': 'Reproductive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Lisa.Callegari@va.gov', 'phone': '206-277-3129', 'title': 'Lisa Callegari (Principal Investigator)', 'organization': 'VA Puget Sound Health Care System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Limitations of the study that impacted our ability to assess the effectiveness of the intervention include (1) lower than expected adherence (use of the MyPath tool) and (2) higher than expected lost-to-follow-up for our primary outcome at the post-visit timeframe.'}}, 'adverseEventsModule': {'timeFrame': 'from enrollment through 6 months follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention (MyPath) Patients', 'description': 'Patients scheduled to see providers randomized to the intervention arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.', 'otherNumAtRisk': 209, 'deathsNumAtRisk': 209, 'otherNumAffected': 0, 'seriousNumAtRisk': 209, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care Patients', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.', 'otherNumAtRisk': 182, 'deathsNumAtRisk': 182, 'otherNumAffected': 0, 'seriousNumAtRisk': 182, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Intervention (MyPath) Providers', 'description': 'Providers randomized to the intervention arm.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Usual Care Providers', 'description': 'Providers randomized to the usual care arm.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'title': 'Yes (discussion with SDM occurred)', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'No (discussion with SDM did not occur)', 'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}, {'title': 'Missing (lost to follow-up for the post-visit survey)', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Missing (declined to answer one or more outcome measure questions)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.46', 'ciLowerLimit': '0.70', 'ciUpperLimit': '3.06', 'pValueComment': 'The threshold for significance was set at p\\<0.05.', 'groupDescription': 'We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm. Analyses accounted for missing data in outcome and a priori adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.'}, {'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Threshold for significance was set at p\\<0.05.', 'groupDescription': 'Per the study protocol, to account for noncompliance, we estimated the "complier average causal effect" to estimate the causal effect of using the MyPath tool on the outcome. Our model accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE) in R.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.', 'otherAnalysisDescription': 'P-value and estimated OR (95% CI) is not available because the model did not converge.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within one month post-visit', 'description': 'Self-report of whether a discussion occurred during the scheduled primary care visit about pregnancy goals, prepregnancy health, or contraception that included shared decision making (SDM). SDM is measured by participant self-report with the CollaboRATE scale, which uses three 5-point Likert scale questions to assess SDM (score 0-12, with higher scores indicating more shared decision making; SDM defined using a top box score).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Veterans were excluded from the analytic sample if they were withdrawn from the study prior to any outcomes assessment due to non-attendance at their scheduled primary care visit, pregnancy diagnosed at the scheduled primary care visit, or self-withdrawal prior to outcomes assessment.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Reproductive Needs Discussion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'title': 'Yes (discussion occurred)', 'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}, {'title': 'No (discussion did not occur)', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}, {'title': 'Missing (lost to follow-up for post-visit survey)', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Missing (declined one or more measure questions)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '0.79', 'ciUpperLimit': '2.38', 'pValueComment': 'Threshold for significance was set at p\\<0.05.', 'groupDescription': 'We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach. Analyses accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.'}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.46', 'ciLowerLimit': '1.23', 'ciUpperLimit': '9.76', 'pValueComment': 'Threshold for significance was set at p\\<0.05.', 'groupDescription': 'Per the study protocol, to account for noncompliance, we estimated the "complier average causal effect" to estimate the causal effect of using the MyPath tool on the outcome. Our model accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE) in R.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within one month post-visit', 'description': 'Self-report of whether a discussion of pregnancy goals, prepregnancy health, or contraception occurred during the scheduled primary care visit, regardless of occurrence of SDM.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Veterans were excluded from the analytic sample if they were withdrawn from the study prior to any outcomes assessment due to non-attendance at their scheduled primary care visit, pregnancy diagnosed at the scheduled primary care visit, or self-withdrawal prior to outcomes assessment.'}, {'type': 'SECONDARY', 'title': 'Perceived Self-efficacy in Communicating With Providers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-1.71', 'ciUpperLimit': '0.48', 'pValueComment': 'Threshold for significance was set at p\\<0.05.', 'groupDescription': 'We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach. Analyses accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE).', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.'}, {'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.84', 'ciLowerLimit': '-2.91', 'ciUpperLimit': '1.22', 'pValueComment': 'Threshold for significance was set at p\\<0.05.', 'groupDescription': 'Per the study protocol, to account for noncompliance, we estimated the "complier average causal effect" to estimate the causal effect of using the MyPath tool on the outcome. Our model accounted for missing data in outcome and baseline adjustment variables through multiple imputation (MI) using Multiple Imputation by Chained Equations (MICE) in R.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.'}], 'paramType': 'MEAN', 'timeFrame': 'Within one month post-visit', 'description': 'Assessed with a modified version of the validated 5-item Perceived Efficacy in Patient-Provider Interactions (PEPPI) scale, which uses five Likert scale questions ranging from 1 to 5 (score 5-25, with higher scores indicating higher levels of perceived efficacy).', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Veterans were excluded from the analytic sample if they were withdrawn from the study prior to any outcomes assessment due to non-attendance at their scheduled primary care visit, pregnancy diagnosed at the scheduled primary care visit, or self-withdrawal prior to outcomes assessment.'}, {'type': 'SECONDARY', 'title': 'Reproductive Health Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.94', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '7.89', 'spread': '2.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '1.26', 'pValueComment': 'Threshold for significance was set at p\\<0.05.', 'groupDescription': 'We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.'}, {'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '2.02', 'pValueComment': 'Threshold for significance was set at p\\<0.05.', 'groupDescription': 'Per the study protocol, to account for noncompliance, we estimated the "complier average causal effect" to estimate the causal effect of using the MyPath tool on the outcome.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.'}], 'paramType': 'MEAN', 'timeFrame': 'Within one month post-visit', 'description': 'Participant responses to 14 items assessing knowledge of fertility, prepregnancy health, and contraception. The measure is self-developed and derived from previously published assessments of fertility and contraceptive knowledge. Responses will be coded as correct vs. incorrect, with "don\'t know" coded as incorrect (score 0-14, with higher scores indicating more accurate knowledge).', 'unitOfMeasure': 'Number correct', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}, {'type': 'SECONDARY', 'title': 'Contraceptive Decision Conflict', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.94', 'spread': '17.57', 'groupId': 'OG000'}, {'value': '20.04', 'spread': '20.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.26', 'ciLowerLimit': '-9.94', 'ciUpperLimit': '5.42', 'pValueComment': 'Threshold for significance was set at p\\<0.05.', 'groupDescription': 'We used a multilevel regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.72', 'ciLowerLimit': '-25.37', 'ciUpperLimit': '-2.06', 'pValueComment': 'Threshold for significance was set at p\\<0.05.', 'groupDescription': 'Per the study protocol, to account for noncompliance, we estimated the "complier average causal effect" to estimate the causal effect of using the MyPath tool on the outcome.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.'}], 'paramType': 'MEAN', 'timeFrame': 'Within one month post-visit', 'description': "Assessed with the Decision Conflict Scale (DCS), a validated measure to assess patients' decisional conflict in medical decision making. The DCS includes 16-items with 5-point Likert scale response options ranging from 0-4. Scores are converted to range from 0 (no decisional conflict) to 100 (highest decisional conflict). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.", 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}, {'type': 'SECONDARY', 'title': 'Confidence That Contraceptive Method is "Right for me."', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.29', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '4.29', 'spread': '1.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.47', 'pValueComment': 'Threshold for significance was set at p\\<0.05.', 'groupDescription': 'We used a multilevel regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '1.25', 'pValueComment': 'Threshold for significance was set at p\\<0.05.', 'groupDescription': 'Per the study protocol, to account for noncompliance, we estimated the "complier average causal effect" to estimate the causal effect of using the MyPath tool on the outcome.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Within one month post-visit', 'description': 'Assessed using a single question ("How confident are you that this contraceptive method is right for you?") with Likert response options from 1 (not at all confident) to 5 (completely confident). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}, {'type': 'SECONDARY', 'title': 'Choice of Prescription or Procedural Contraceptive Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'title': 'Prescription or procedural method', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'Non-prescription or no method', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Missing (lost to follow-up)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Missing (did not answer question(s))', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within one month post-visit', 'description': 'Self-report of continuing or changing to a prescription or procedural method after their visit. Prescription or procedural methods are defined as any of the following: birth control pills, patch, ring, injection, implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}, {'type': 'SECONDARY', 'title': 'Choice of Procedural Contraceptive Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'title': 'Procedural method', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Non-procedural or no method', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Missing (lost to follow-up for post-visit survey)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Missing (did not answer question(s))', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within one month post-visit', 'description': 'Self-report of continuing or changing to a procedural method after their visit. Procedural methods are defined as any of the following: implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}, {'type': 'SECONDARY', 'title': 'Use of Prescription or Procedural Contraceptive Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'title': 'Prescription or procedural method', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Non-prescription or no method', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Missing (lost to follow-up 6-month survey)', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Missing (did not answer question(s) due to pregnancy)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Self-reported use of a prescription or procedural method at follow-up. Prescription or procedural methods are defined as any of the following: birth control pills, patch, ring, injection, implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}, {'type': 'SECONDARY', 'title': 'Use of Procedural Contraceptive Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'title': 'Procedural method', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Non-procedural or no method', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': 'Missing (lost to follow-up 6-month survey)', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Missing (did not answer question(s) due to pregnancy)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Self-reported use of a procedural method at follow-up. Procedural methods are defined as any of the following: implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}, {'type': 'SECONDARY', 'title': 'Continuous Use of Any Contraception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'title': 'Continuous use over 6 months', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Non-continuous use over 6 months', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Missing (lost to follow-up for 6 month survey)', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Missing (did not answer question(s) due to pregnancy)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Self-reported use of a contraceptive method over the past 6 months without a gap of greater than 4 weeks. This combines self-reported use at 3 months and 6 months. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy. For participants lost to follow-up at the 6 month timepoint, their 6-month values will be singly imputed, carrying forward 3-month continuous use reports when those data are available.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}, {'type': 'SECONDARY', 'title': 'Continuous Use of Prescription or Procedural Contraception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'title': 'Continuous Use of Rx/Procedural Contraception', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Non-Continuous Use of Rx/Procedural Contraception', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Missing (lost to follow-up for 6-month survey)', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Missing (did not answer question(s) due to pregnancy)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Self-reported use of a prescription or procedural contraceptive method over the past 6 months without a gap of greater than 4 weeks. Prescription or procedural methods are defined as any of the following: birth control pills, patch, ring, injection, implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}, {'type': 'SECONDARY', 'title': 'Continuous Use of Procedural Contraception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'title': 'Continuous Use of Procedural Contraception', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Non-continuous Use of Procedural Contraception', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Missing (lost to follow-up for 6-month survey)', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Missing (did not answer question(s) due to pregnancy)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Self-reported use of a procedural contraceptive method over the past 6 months without a gap of greater than 4 weeks. Procedural methods are defined as any of the following: implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Contraceptive Method Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.28', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '4.35', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Assessed using a single question ("How satisfied are you with your current birth control method") with Likert response options from 1 (very dissatisfied) to 5 (very satisfied). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy. While this outcome was measured at 6 months, for participants lost to follow-up at 6 months, we singly imputed these data by pulling forward their 3-month satisfaction, when available.', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}, {'type': 'SECONDARY', 'title': 'Incidence of Unplanned Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'title': 'Unplanned pregnancy', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'No unplanned pregnancy', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Missing (lost to follow-up 6 month survey)', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Proportion of participants who self-report an unplanned pregnancy, as determined by responses to the 6-item London Measure of Unplanned Pregnancy. The London Measure includes items measuring attitude towards an experienced pregnancy and behaviors before pregnancy to determine the intendedness of pregnancy. The score range of the London Measure is 0-12, with a score of \\<10 indicating unplanned pregnancy and a score of 10 or higher indicating planned pregnancy. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}, {'type': 'SECONDARY', 'title': 'Confidence That Current Contraceptive Method is "Right for me."', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.26', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '4.21', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Assessed using a single question ("How confident are you that this contraceptive method is right for you?") with Likert response options from 1 (not at all confident) to 5 (completely confident). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Goals-concordant Contraceptive Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'title': 'Yes (goals-concordant contraceptive use)', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'No (not goals-concordant contraceptive use)', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Missing (lost to follow-up at 6-months)', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Missing (not asked question(s) due to pregnancy)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Self-reported contraception use among participants at 6 months that is consistent with their orientation towards pregnancy at 6-months (desires pregnancy now, not trying but OK with it, desires pregnancy later but not now, never desires pregnancy, not sure), regardless of their intention at baseline. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy. For Veterans who desire pregnancy now, goals-concordant contraceptive use is defined as not using contraception. For Veterans who desire pregnancy later, never, or are unsure, goals-concordant contraceptive use is defined as using contraception. For Veterans who are not trying to get pregnant but would be OK with it, goals-concordant contraceptive use is defined as either using or not using contraception.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Contraceptive Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.42', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '4.15', 'spread': '1.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.99', 'pValueComment': 'threshold for significance set at \\<0.05', 'groupDescription': 'We used a multilevel logistic regression model to test whether the outcome was significantly different in the intervention versus control arm, using an Intent to Treat approach.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.'}, {'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.04', 'ciUpperLimit': '1.75', 'pValueComment': 'Threshold for significance was set at p\\<0.05.', 'groupDescription': 'Per the study protocol, to account for noncompliance, we estimated the "complier average causal effect" to estimate the causal effect of using the MyPath tool on the outcome.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for site, provider clinic type, provider, Veteran age, Veteran race, Veteran education, and Veteran health insurance status.'}], 'paramType': 'MEAN', 'timeFrame': 'Within one month post-visit', 'description': 'Participant responses to 8 items assessing knowledge of contraception. The measure derived from previously published assessments of contraceptive knowledge. Responses will be coded as correct vs. incorrect, with "don\'t know" coded as incorrect (score 0-8, with higher scores indicating more accurate knowledge).', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was measured within a prespecified analytic subgroup (n=150) defined at study enrollment (pre-intervention) as potentially at risk of unintended pregnancies, defined using baseline measures of current pregnancy desires (does not desire pregnancy now or within the next year), pregnancy capability (does not report a prior tubal sterilization) and sexual activity (reports sex with a male partner in the past 12 months).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention (MyPath)', 'description': 'Providers were randomized to the intervention (MyPath) or usual care arm of the study. Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'FG001', 'title': 'Usual Care Patients', 'description': 'Providers were randomized to the intervention (MyPath) or usual care arm of the study. Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}], 'periods': [{'title': 'Enrollment to Post-Visit - PATIENTS', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '182'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '190'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Did not attend scheduled appointment with primary care provider', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '3-month Follow-up - PATIENTS', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '190'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '158'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '6-month Follow-up - PATIENTS', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '158'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Enrollment to Post-Visit - PROVIDERS', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'No Veterans Enrolled in Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'VA primary care providers from 12 VA healthcare systems were enrolled and randomized to the intervention or control arm of the study. Veteran patients were subsequently recruited and enrolled into the study if they had an upcoming, scheduled appointment with a study provider. Veterans were automatically assigned to the study arm of the provider they were scheduled to see.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '415', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention (MyPath) Patients', 'description': 'Patients scheduled to see providers randomized to this arm received a weblink to the MyPath decision tool via text message after study enrollment and prior to their scheduled visit.'}, {'id': 'BG001', 'title': 'Usual Care Patients', 'description': 'Patients scheduled to see providers randomized to the usual care arm received no intervention text message and received usual care.'}, {'id': 'BG002', 'title': 'Intervention (MyPath) Providers', 'description': 'This arm includes providers who were randomized to the intervention arm of the study and had at least one patient subsequently enroll.'}, {'id': 'BG003', 'title': 'Usual Care Providers', 'description': 'This arm includes providers who were randomized to the usual care arm of the study and had at least one patient subsequently enroll.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '413', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '45'}, {'value': '35.1', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '45'}, {'value': '47.7', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '67'}, {'value': '47.7', 'groupId': 'BG003', 'lowerLimit': '28', 'upperLimit': '64'}, {'value': '37.3', 'groupId': 'BG004', 'lowerLimit': '21', 'upperLimit': '67'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years of age', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '410', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '338', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported Hispanic/Latina Ethnicity', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '152', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '170', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported Racial Identity', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sexual Orientation', 'classes': [{'categories': [{'title': 'Straight/Heterosexual', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '269', 'groupId': 'BG004'}]}, {'title': 'Lesbian/Gay', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}, {'title': 'Bisexual/Pansexual', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Missing or Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported sexual orientation identity. This question was asked of patients only (not providers).', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Some high school or GED', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}, {'title': "Some college or Associate's Degree", 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '142', 'groupId': 'BG004'}]}, {'title': "Bachelor's Degree or Higher", 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '178', 'groupId': 'BG004'}]}, {'title': 'Missing or Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported highest level of education. This was asked of patients only (not providers).', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Health Insurance Status', 'classes': [{'categories': [{'title': 'Yes (separate health insurance)', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}]}, {'title': 'No (VA coverage only)', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '188', 'groupId': 'BG004'}]}, {'title': 'Missing or Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported whether patient has health insurance benefits separate/in addition to VA health coverage. This was asked of patients only (not providers).', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Current thoughts/desires regarding pregnancy', 'classes': [{'categories': [{'title': 'Desires pregnancy now', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': 'Not trying to get pregnant, but okay with it', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}, {'title': 'Not now, but desires pregnancy in future', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '101', 'groupId': 'BG004'}]}, {'title': 'Does not desire a future pregnancy (ever)', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}]}, {'title': 'Unsure about pregnancy desires', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}, {'title': 'Missing or Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Self-report of patient's current thoughts/desires regarding pregnancy. This was asked of patients only (not providers).", 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex with a male partner, past 12 months', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '264', 'groupId': 'BG004'}]}, {'title': 'No', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}, {'title': 'Missing or Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-report of whether patient was sexually active with a male partner during the 12 months prior to enrollment. This was asked of patients only (not providers).', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Participants enrolled per study provider', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '28'}, {'value': '5.0', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '18'}, {'value': '5.6', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '28'}, {'value': '5.0', 'groupId': 'BG003', 'lowerLimit': '1', 'upperLimit': '18'}, {'value': '5.3', 'groupId': 'BG004', 'lowerLimit': '1', 'upperLimit': '28'}]}]}], 'paramType': 'MEAN', 'description': 'Participants were included in the analytic sample if they attended a primary care visit at VA with a study provider.', 'unitOfMeasure': 'Veteran participants per provider', 'dispersionType': 'FULL_RANGE'}, {'title': 'Participants enrolled by study provider practice setting', 'classes': [{'categories': [{'title': "Women's clinic provider", 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '146', 'groupId': 'BG004'}]}, {'title': "Non-women's clinic provider", 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '269', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Some providers practice within a designated women's clinic at a VA Medical Center, while other study providers do not (i.e., practice in other general primary care clinics). Providers are categorized based on their own practice setting. Patients are categorized based on the practice setting of the provider they saw.", 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Appointment modality', 'classes': [{'categories': [{'title': 'In-person appointment', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '278', 'groupId': 'BG004'}]}, {'title': 'Virtual/telephone appointment', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}, {'title': 'Does not apply (for providers)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Patients were included in the analytic sample if they attended a primary care visit at VA with a study provider. This measure captures whether the patient's visit was conducted in-person versus telehealth or virtual care. This is measured by self-report for patients who completed the post-visit survey. For patients who did not complete the post-visit survey, this was obtained through medical record review. This measure does not apply to providers.", 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'History of prior appointment(s) with study provider', 'classes': [{'categories': [{'title': 'Yes (prior appointment(s) documented)', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '271', 'groupId': 'BG004'}]}, {'title': 'No (no prior appointment(s) documented)', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}, {'title': 'Does not apply (providers)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients were included in the analytic sample if they attended a primary care visit at VA with a study provider. This measure captures whether patient participants had medical record evidence of attending at last one prior appointment with their study provider within the 2 years prior to their study visit. This measure does not apply to study providers.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Annual household income', 'classes': [{'categories': [{'title': '<$20,000', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': '$20,000-$79,999', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '197', 'groupId': 'BG004'}]}, {'title': '>=$80,000', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '119', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported annual household income. This was asked of patients only (not providers).', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'History of military deployment', 'classes': [{'categories': [{'title': 'Yes (deployed)', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '188', 'groupId': 'BG004'}]}, {'title': 'No (never deployed)', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported measure of whether participant was ever deployed during their military service. This was asked of patients only (not providers).', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'History of military sexual trauma (MST)', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '149', 'groupId': 'BG004'}]}, {'title': 'No', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '200', 'groupId': 'BG004'}]}, {'title': 'Does not apply (providers)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Obtained from patient VA medical records data (via the VA Corporate Data Warehouse). This captures whether a "yes" was every documented in the medical record for MST. This measure does not apply to providers.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ever experienced racial discrimination in VA care', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}, {'title': 'No', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '287', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measured using the Discrimination in Medical Settings Scale. Participants were prompted to think about care they have received from VA. Racial discrimination was defined as an answer of "sometimes," "most of the time," or "always" to any of the statements. This was asked of patients only (not providers).', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Satisfaction with VA care, past 12 months', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '220', 'groupId': 'BG004'}]}, {'title': 'No', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measured using one question with answer options using a five-point scale ranging from "very satisfied\' (score of 5) to "very dissatisfied" (score of 1). Overall satisfaction was defined as a score of 4 or 5 out of 5. This was asked of patients only (not providers).', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Has >=1 chronic medical condition (self-report)', 'classes': [{'categories': [{'title': '>=1 chronic medical condition', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '241', 'groupId': 'BG004'}]}, {'title': 'No chronic medical condition', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '108', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Veteran response (yes/no) to the following question: "Do you have any chronic medical conditions, such as diabetes, high blood pressure, migraines, asthma, or others?"', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Has >=1 mental health condition (self-report)', 'classes': [{'categories': [{'title': '>=1 mental health condition', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '298', 'groupId': 'BG004'}]}, {'title': 'No mental health condition', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Veteran response (yes/no) to the following question: "Do you have any mental health conditions, such as depression, anxiety, bi-polar disorder, post-traumatic stress disorder, or others?" This was asked of patients only (not providers).', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Provider Type', 'classes': [{'categories': [{'title': 'Physician', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}, {'title': 'Nurse Practitioner', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'Physician Assistant', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Does not apply (patients)', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '349', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Type of medical practitioner (self-report). This was asked of providers only (not patients).', 'unitOfMeasure': 'Participants'}, {'title': 'Years practicing in VA', 'classes': [{'categories': [{'title': '<5 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': '5-10 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': '>=10 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '350', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The number of years a provider has been practicing in VA. This was asked of providers only (not patients).', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Per the study protocol, enrolled Veterans were excluded from the analytic sample if they were withdrawn from the study prior to any outcomes assessment due to non-attendance at their scheduled primary care visit, pregnancy diagnosed at the scheduled primary care visit, or self-withdrawal prior to outcomes assessment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-24', 'size': 436775, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-12T17:56', 'hasProtocol': True}, {'date': '2024-02-23', 'size': 347999, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-01T12:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Research assistants (RAs) who assess outcomes will remain blinded to provider study arm assignment throughout the trial. RAs will be blinded to patient study arm assignment during patient enrollment and baseline surveys but will become unblinded to individual patient study arm assignment during the course of outcome assessment.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Provider participants are randomized to one of two groups - usual care or intervention group - at the start of the study, prior to any Veteran enrollment. Subsequently, Veterans scheduled to see these providers will be enrolled as patient participants and automatically allocated to the study group of their scheduled provider.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 465}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2020-10-05', 'resultsFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2020-10-05', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-22', 'studyFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Goals-concordant Contraceptive Use', 'timeFrame': '6 months', 'description': 'Self-reported contraception use among participants at 6 months that is consistent with their orientation towards pregnancy at 6-months (desires pregnancy now, not trying but OK with it, desires pregnancy later but not now, never desires pregnancy, not sure), regardless of their intention at baseline. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy. For Veterans who desire pregnancy now, goals-concordant contraceptive use is defined as not using contraception. For Veterans who desire pregnancy later, never, or are unsure, goals-concordant contraceptive use is defined as using contraception. For Veterans who are not trying to get pregnant but would be OK with it, goals-concordant contraceptive use is defined as either using or not using contraception.'}, {'measure': 'Contraceptive Knowledge', 'timeFrame': 'Within one month post-visit', 'description': 'Participant responses to 8 items assessing knowledge of contraception. The measure derived from previously published assessments of contraceptive knowledge. Responses will be coded as correct vs. incorrect, with "don\'t know" coded as incorrect (score 0-8, with higher scores indicating more accurate knowledge).'}], 'primaryOutcomes': [{'measure': 'Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM)', 'timeFrame': 'Within one month post-visit', 'description': 'Self-report of whether a discussion occurred during the scheduled primary care visit about pregnancy goals, prepregnancy health, or contraception that included shared decision making (SDM). SDM is measured by participant self-report with the CollaboRATE scale, which uses three 5-point Likert scale questions to assess SDM (score 0-12, with higher scores indicating more shared decision making; SDM defined using a top box score).'}], 'secondaryOutcomes': [{'measure': 'Occurrence of Reproductive Needs Discussion', 'timeFrame': 'Within one month post-visit', 'description': 'Self-report of whether a discussion of pregnancy goals, prepregnancy health, or contraception occurred during the scheduled primary care visit, regardless of occurrence of SDM.'}, {'measure': 'Perceived Self-efficacy in Communicating With Providers', 'timeFrame': 'Within one month post-visit', 'description': 'Assessed with a modified version of the validated 5-item Perceived Efficacy in Patient-Provider Interactions (PEPPI) scale, which uses five Likert scale questions ranging from 1 to 5 (score 5-25, with higher scores indicating higher levels of perceived efficacy).'}, {'measure': 'Reproductive Health Knowledge', 'timeFrame': 'Within one month post-visit', 'description': 'Participant responses to 14 items assessing knowledge of fertility, prepregnancy health, and contraception. The measure is self-developed and derived from previously published assessments of fertility and contraceptive knowledge. Responses will be coded as correct vs. incorrect, with "don\'t know" coded as incorrect (score 0-14, with higher scores indicating more accurate knowledge).'}, {'measure': 'Contraceptive Decision Conflict', 'timeFrame': 'Within one month post-visit', 'description': "Assessed with the Decision Conflict Scale (DCS), a validated measure to assess patients' decisional conflict in medical decision making. The DCS includes 16-items with 5-point Likert scale response options ranging from 0-4. Scores are converted to range from 0 (no decisional conflict) to 100 (highest decisional conflict). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy."}, {'measure': 'Confidence That Contraceptive Method is "Right for me."', 'timeFrame': 'Within one month post-visit', 'description': 'Assessed using a single question ("How confident are you that this contraceptive method is right for you?") with Likert response options from 1 (not at all confident) to 5 (completely confident). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.'}, {'measure': 'Choice of Prescription or Procedural Contraceptive Method', 'timeFrame': 'Within one month post-visit', 'description': 'Self-report of continuing or changing to a prescription or procedural method after their visit. Prescription or procedural methods are defined as any of the following: birth control pills, patch, ring, injection, implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.'}, {'measure': 'Choice of Procedural Contraceptive Method', 'timeFrame': 'Within one month post-visit', 'description': 'Self-report of continuing or changing to a procedural method after their visit. Procedural methods are defined as any of the following: implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.'}, {'measure': 'Use of Prescription or Procedural Contraceptive Method', 'timeFrame': '6 months', 'description': 'Self-reported use of a prescription or procedural method at follow-up. Prescription or procedural methods are defined as any of the following: birth control pills, patch, ring, injection, implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.'}, {'measure': 'Use of Procedural Contraceptive Method', 'timeFrame': '6 months', 'description': 'Self-reported use of a procedural method at follow-up. Procedural methods are defined as any of the following: implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.'}, {'measure': 'Continuous Use of Any Contraception', 'timeFrame': '6 months', 'description': 'Self-reported use of a contraceptive method over the past 6 months without a gap of greater than 4 weeks. This combines self-reported use at 3 months and 6 months. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy. For participants lost to follow-up at the 6 month timepoint, their 6-month values will be singly imputed, carrying forward 3-month continuous use reports when those data are available.'}, {'measure': 'Continuous Use of Prescription or Procedural Contraception', 'timeFrame': '6 months', 'description': 'Self-reported use of a prescription or procedural contraceptive method over the past 6 months without a gap of greater than 4 weeks. Prescription or procedural methods are defined as any of the following: birth control pills, patch, ring, injection, implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.'}, {'measure': 'Continuous Use of Procedural Contraception', 'timeFrame': '6 months', 'description': 'Self-reported use of a procedural contraceptive method over the past 6 months without a gap of greater than 4 weeks. Procedural methods are defined as any of the following: implants, IUDs, and male and female sterilization. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.'}, {'measure': 'Contraceptive Method Satisfaction', 'timeFrame': '6 months', 'description': 'Assessed using a single question ("How satisfied are you with your current birth control method") with Likert response options from 1 (very dissatisfied) to 5 (very satisfied). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy. While this outcome was measured at 6 months, for participants lost to follow-up at 6 months, we singly imputed these data by pulling forward their 3-month satisfaction, when available.'}, {'measure': 'Incidence of Unplanned Pregnancy', 'timeFrame': '6 months', 'description': 'Proportion of participants who self-report an unplanned pregnancy, as determined by responses to the 6-item London Measure of Unplanned Pregnancy. The London Measure includes items measuring attitude towards an experienced pregnancy and behaviors before pregnancy to determine the intendedness of pregnancy. The score range of the London Measure is 0-12, with a score of \\<10 indicating unplanned pregnancy and a score of 10 or higher indicating planned pregnancy. This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.'}, {'measure': 'Confidence That Current Contraceptive Method is "Right for me."', 'timeFrame': '6 months', 'description': 'Assessed using a single question ("How confident are you that this contraceptive method is right for you?") with Likert response options from 1 (not at all confident) to 5 (completely confident). This measure will be obtained in a pre-defined subset of participants at risk of unintended pregnancy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shared decision making', 'Primary care', 'Patient decision support', 'Patient-centered outcomes research', 'Reproductive autonomy', 'Patient-Centered Care', 'Provider-Patient Communication'], 'conditions': ['Contraception', 'Contraception Behavior', 'Prepregnancy Health', 'Reproductive Health']}, 'referencesModule': {'references': [{'pmid': '36179982', 'type': 'RESULT', 'citation': 'Callegari LS, Benson SK, Mahorter SS, Nelson KM, Arterburn DE, Hamilton AB, Taylor L, Hunter-Merrill R, Gawron LM, Dehlendorf C, Borrero S. Evaluating the MyPath web-based reproductive decision support tool in VA primary care: Protocol for a pragmatic cluster randomized trial. Contemp Clin Trials. 2022 Nov;122:106940. doi: 10.1016/j.cct.2022.106940. Epub 2022 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'The investigators have developed a web-based decision support tool to help women Veterans get the information and care they need to achieve their reproductive goals, whether that includes optimizing their health before desired pregnancies or birth control to avoid unwanted pregnancies. The study will test the effect of sending a weblink to the decision tool to women Veterans prior to primary care visits at the VA. Half of participants will be sent a weblink before their appointment, and half will not be sent the link. The investigators hypothesize that participants who are sent the link will be more likely to report patient-centered discussions of their reproductive needs at visits, feel confident in communicating with their health care providers, have accurate knowledge about reproductive health, and choose birth control methods that best fit their preferences and needs.', 'detailedDescription': "Counseling and care that supports individuals' ability to achieve their reproductive goals is an essential component of primary care. National organizations, including the Centers for Disease Control and Prevention (CDC), recommend that clinicians routinely engage in patient-centered conversations about reproductive goals and offer care to help optimize health and well-being prior to desired pregnancies and to prevent unwanted pregnancy and births. This counseling is particularly critical for women Veterans, who face elevated risks of adverse pregnancy and birth outcomes due to a high prevalence of chronic medical and mental health conditions as well as psychosocial stressors including sexual trauma histories, intimate partner violence, and homelessness. Moreover, stark racial/ethnic disparities in pregnancy outcomes are well-documented, and nearly half of reproductive-aged women Veterans are minority race/ethnicity. Despite these national recommendations, however, conversations about reproductive needs are often absent in primary care both outside and within the VA, and the conversations that do happen frequently fail to incorporate women's values and preferences. Interventions are needed to improve both the frequency and quality of counseling about reproductive needs in primary care settings.\n\nThis study will investigate the effect of a novel, web-based, patient-facing decision support tool designed to be used prior to VA primary care visits to help women Veterans with reproductive capacity consider their reproductive goals; improve their knowledge about fertility, contraception, and prepregnancy health risks; align contraceptive decisions with their preferences and goals; and engage in shared decision making (SDM) with providers.\n\nThe investigators will conduct a multi-site randomized controlled trial (RCT) clustered at the provider level among VA primary care providers and their reproductive-aged women Veteran patients. Study outcomes will be assessed among participants shortly after their scheduled appointment and at 3- and 6-months follow up. The study will test the primary hypothesis that participants who receive the tool weblink prior to visits will be more likely to report patient-centered conversations about their reproductive needs at their visit. The investigators also hypothesize that intervention participants will report higher perceived self-efficacy in communicating with providers, reproductive health knowledge, contraception decision quality, and contraception utilization. Exploratory outcomes include behaviors to modify preconception health risks among participants considering pregnancy in the future and intervention effects by race/ethnicity. The study will also collect quantitative and qualitative data to assess the feasibility of implementing the tool more widely in VA primary care settings."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients:\n\n* Female sex identified in medical record\n* 18 - 44 years old\n* Has a scheduled VA medical appointment with an enrolled study provider\n* Has at least one valid telephone number available in medical record\n* Interested in receiving information or talking with their provider about pregnancy and/or birth control\n\nProviders:\n\n* Primary Care Provider (MD, Nurse Practitioner, Physician Assistant) at a study site\n* Designated as a Women's Health Provider \\[defined in VA directive 1330.01 as primary care providers who have demonstrated proficiency (e.g. pelvic exams and pap smears) in women's health and who have at least 10% of their panel comprised of women\\]\n* Completed appointments with at least 30 unique female patients ages 18-44 in the past year at a study site\n\nExclusion Criteria:\n\nPatients:\n\n* Currently pregnant\n* Medical record or self-reported history of hysterectomy, bilateral oophorectomy; or self-report of not having a uterus\n* Unable to communicate in English\n* Impaired decision-making\n* Used the decision tool prior to study enrollment (e.g. during pilot testing of the tool)\n\nProviders:\n\n* Previous involvement as a provider in MyPath pilot work (identified by the PI)\n* Medical trainee\n* Self-report that they have plans to leave VA, go on extended leave, retire, stop primary care practice, or change VA site in the 18 months following their enrollment"}, 'identificationModule': {'nctId': 'NCT04584294', 'acronym': 'MyPath', 'briefTitle': 'Patient-Centered Reproductive Decision Support Tool for Women Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'MyPath: A Patient-Centered Web-Based Intervention to Improve Reproductive Planning for Women Veterans', 'orgStudyIdInfo': {'id': 'IIR 19-387'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (MyPath)', 'description': 'Patients scheduled to see providers randomized to this arm will receive a weblink to the decision tool via text message after study enrollment and prior to their scheduled visit.', 'interventionNames': ['Behavioral: MyPath Web-Based Informational and Decision Support Tool']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Patients scheduled to see providers randomized to the usual care arm will receive no intervention and will receive usual primary care.'}], 'interventions': [{'name': 'MyPath Web-Based Informational and Decision Support Tool', 'type': 'BEHAVIORAL', 'description': "The MyPath Decision Support Tool includes the following sections and features:\n\n* Questions to capture reproductive goals and orientations towards a potential pregnancy\n* Education modules about the menstrual cycle, fertility, and prepregnancy health with the opportunity to flag topics that are relevant and of interest to the patient\n* A contraceptive decision module that provides education, elicits patient preferences about different aspects of contraception, and suggests methods most appropriate based on the patient's preferences\n* A feature for adding free-text questions that patients may have for their provider\n* An email with a summary page that the patient can bring to a visit to guide discussions with primary care providers about reproductive needs", 'armGroupLabels': ['Intervention (MyPath)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System, San Diego, CA', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Regional VA Medical Center, Aurora, CO', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando VA Medical Center, Orlando, FL', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Medical and Rehab Center, Decatur, GA', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center, Durham, NC', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '15240', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '79930-4211', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'El Paso VA Health Care System, El Paso, TX', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. DeBakey VA Medical Center, Houston, TX', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229-4404', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Health Care System, San Antonio, TX', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76504-7451', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Veterans Health Care System, Temple, TX', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '84148-0001', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'VA Salt Lake City Health Care System, Salt Lake City, UT', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98108-1532', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Lisa S Callegari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will be deposited into the data repository and registry described above at study closure. It is the intention of the repository team to store the data in the repository indefinitely.\n\nIn accordance with VHA regulations, the repository will be terminated only under the direction of the VA IRB or R\\&D Committee responsible for the oversight of the repository. If the repository is terminated, the data will only be re-used or transferred to another data repository if the IRB and/or R\\&D approves of the transfer. The repository data may need to be destroyed if appropriate control of the data and compliance with VA and VHA requirements cannot be maintained.\n\nIf the repository is terminated, the data will be destroyed in accordance with all VA and VHA records disposition requirements. We will retain these data for the minimum period required for records retention in accordance with the National Archives and Records Administration (NARA) VHA Record Control Schedule (RCS).', 'ipdSharing': 'YES', 'description': 'Veteran participant data will be deposited into the "Reproductive, Sexual, and Socio-Behavioral Health Data Repository and Registry" VA data repository and registry housed and managed at the VA Puget Sound Health Care System. The data will be stored indefinitely in accordance with VHA regulations under VA IRB and R\\&D Committee oversight. Procedures are as follows.', 'accessCriteria': 'Study data may be requested by VA investigators (all investigators must receive regulatory approval and sign a Data Use Agreement before gaining access to the data). The data repository will only be used to answer questions for approved studies and/or for activities preparatory to research. For activities preparatory to research, staff may only use aggregate data, and only for background information, to justify the research, or to verify proposed sample size requirements.\n\nData from this study will be made available outside VA in response to a properly prepared Freedom of Information Act request submitted to the VA Puget Sound FOIA Officer, or submitted and passed down to the facility FOIA Officer from higher VA authority (e.g. VISN 20 or Central Office). Research publications will be made available to the public via the National Library of Medicine PubMed Central website within one year after publication date(s).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'Kaiser Permanente', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}