Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-29 @ 9:11 PM
Study NCT ID:
NCT04369404
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2020-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Decision Aids in Urogynecology
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ksepucha@mgh.harvard.edu', 'phone': '617-724-3350', 'title': 'Karen Sepucha, PhD', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed within one day of survey receipt. The surveys were completed within 2 weeks of the visit and were checked as they came in for evidence of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'In the usual care group, the providers do not have access to the decision aids.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patient Decision Aid', 'description': 'Providers have access to patient decision aids to review and discuss during the visit.\n\nPelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse\n\nStress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.\n\nOveractive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'In the usual care group, the providers do not have access to the decision aids.'}, {'id': 'OG001', 'title': 'Patient Decision Aid', 'description': 'Providers have access to patient decision aids to review and discuss during the visit.\n\nPelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse\n\nStress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.\n\nOveractive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '30', 'groupId': 'OG000'}, {'value': '72', 'spread': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12', 'ciLowerLimit': '0.7', 'ciUpperLimit': '24.6', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'We hypothesize that participants who received the decision aid will have higher knowledge. This is pilot study, thus we did not have a power calculation.'}], 'paramType': 'MEAN', 'timeFrame': 'Within 1 day', 'description': 'Patients completed four multiple choice knowledge items for each condition and a total knowledge score (0-4) was calculated. The score was converted to a 0-100% scale, with higher scores indicating higher knowledge.', 'unitOfMeasure': 'percentage of questions answered correct', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Anyone who answered the knowledge items.'}, {'type': 'PRIMARY', 'title': 'Patient Treatment Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'In the usual care group, the providers do not have access to the decision aids.'}, {'id': 'OG001', 'title': 'Patient Decision Aid', 'description': 'Providers have access to patient decision aids to review and discuss during the visit.\n\nPelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse\n\nStress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.\n\nOveractive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.'}], 'classes': [{'title': 'clear treatment preference', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'unsure treatment preference', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.085', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Pearson Chi-Square', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.970', 'groupDescription': 'a chisquare test was conducted to determine if the proportion of treatment "unsure" responses were different between the usual care and intervention arms.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 1 day', 'description': "1 item assess patients' preferred treatment- Response options included no treatment at this time, conservative and non conservative options, or I am not sure. Responses were categorized into clear treatment preference (no treatment, conservative and non-conservative options) vs unsure (I am not sure) treatment preference.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Physician Visit Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'In the usual care group, the providers do not have access to the decision aids.'}, {'id': 'OG001', 'title': 'Patient Decision Aid', 'description': 'Providers have access to patient decision aids to review and discuss during the visit.\n\nPelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse\n\nStress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.\n\nOveractive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.'}], 'classes': [{'title': 'Not at all satisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat satisfied', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Extremely satisfied', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Pearson Chi-Square', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.524', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 1 day', 'description': 'Physicians answered 1 item on how satisfied they were with the visit: Extremely satisfied, Very satisfied, Somewhat satisfied, and Not at all satisfied', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Physicians were not considered enrolled in the study, but did contribute to this assessment.'}, {'type': 'SECONDARY', 'title': 'SURE Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'In the usual care group, the providers do not have access to the decision aids.'}, {'id': 'OG001', 'title': 'Patient Decision Aid', 'description': 'Providers have access to patient decision aids to review and discuss during the visit.\n\nPelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse\n\nStress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.\n\nOveractive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 1 day', 'description': 'Measures decisional conflict, consists of 4 yes/no items. Total scores range 0-4 where 4 indicates no decisional conflict and scores less than or equal to 3 indicate decisional conflict. The number of participants who got a total score of 4, indicating no decisional conflict, is reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CollaboRATE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'In the usual care group, the providers do not have access to the decision aids.'}, {'id': 'OG001', 'title': 'Patient Decision Aid', 'description': 'Providers have access to patient decision aids to review and discuss during the visit.\n\nPelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse\n\nStress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.\n\nOveractive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 1 day', 'description': 'Three items ask patients to rate their provider on a scale of 1-10, with 10 being outstanding. The measure is a dichotomized score. Participants who reported a "10" on all 3 items were "topscored" into one group; everyone else were categorized into another group. The number of participants who gave a topscore (a "10" for all 3 items) was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SDM Process Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'In the usual care group, the providers do not have access to the decision aids.'}, {'id': 'OG001', 'title': 'Patient Decision Aid', 'description': 'Providers have access to patient decision aids to review and discuss during the visit.\n\nPelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse\n\nStress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.\n\nOveractive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.18', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '3.17', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 1 day', 'description': 'Four items that measures the amount of shared decision making that occurs in an interaction. Total scores ranged from 0-4, with higher scores indicating more shared decision making occurred.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MD Perceptions of Length of Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'In the usual care group, the providers do not have access to the decision aids.'}, {'id': 'OG001', 'title': 'Patient Decision Aid', 'description': 'Providers have access to patient decision aids to review and discuss during the visit.\n\nPelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse\n\nStress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.\n\nOveractive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 1 day', 'description': 'One item assessed how physician felt about the length of the visit. Responses were: Shorter than normal, About normal, Longer than normal. Number of physicians who responded that the visit was "shorter than normal" or "about normal" is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Physicians were not considered enrolled in the study, but did contribute to this assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'In the usual care group, the providers do not have access to the decision aids.'}, {'id': 'FG001', 'title': 'Patient Decision Aid', 'description': 'Providers have access to patient decision aids to review and discuss during the visit.\n\nPelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse\n\nStress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.\n\nOveractive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Eligible participants were patients who had scheduled a visit with the Female Pelvic Medicine and Reconstructive Surgery Division of the Obstetrics and Gynecology Department at Massachusetts General Hospital between February 2019 - April 2019\n\nEligible patients were English speaking and between 18-95 years old. They had scheduled a visit for either pelvic organ prolapse, stress urinary incontinence, or overactive bladder.', 'preAssignmentDetails': 'Patients with prior surgery for pelvic organ prolapse or incontinence, or did not attend the scheduled visit were ineligible.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'In the usual care group, the providers do not have access to the decision aids.'}, {'id': 'BG001', 'title': 'Patient Decision Aid', 'description': 'Providers have access to patient decision aids to review and discuss during the visit.\n\nPelvic organ prolapse decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse\n\nStress urinary incontinence decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.\n\nOveractive bladder decision aid: Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '14.7', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '58.9', 'spread': '14.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants were recruited from the Urogynecology Clinic at the Massachusetts General Hospital in Boston, MA', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-05', 'size': 171411, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-07T12:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'A usual care arm was recruited first, then the intervention arm was recruited.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2020-03-24', 'resultsFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-15', 'studyFirstPostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Knowledge', 'timeFrame': 'Within 1 day', 'description': 'Patients completed four multiple choice knowledge items for each condition and a total knowledge score (0-4) was calculated. The score was converted to a 0-100% scale, with higher scores indicating higher knowledge.'}, {'measure': 'Patient Treatment Preference', 'timeFrame': 'Within 1 day', 'description': "1 item assess patients' preferred treatment- Response options included no treatment at this time, conservative and non conservative options, or I am not sure. Responses were categorized into clear treatment preference (no treatment, conservative and non-conservative options) vs unsure (I am not sure) treatment preference."}, {'measure': 'Physician Visit Satisfaction', 'timeFrame': 'Within 1 day', 'description': 'Physicians answered 1 item on how satisfied they were with the visit: Extremely satisfied, Very satisfied, Somewhat satisfied, and Not at all satisfied'}], 'secondaryOutcomes': [{'measure': 'SURE Scale', 'timeFrame': 'Within 1 day', 'description': 'Measures decisional conflict, consists of 4 yes/no items. Total scores range 0-4 where 4 indicates no decisional conflict and scores less than or equal to 3 indicate decisional conflict. The number of participants who got a total score of 4, indicating no decisional conflict, is reported'}, {'measure': 'CollaboRATE', 'timeFrame': 'Within 1 day', 'description': 'Three items ask patients to rate their provider on a scale of 1-10, with 10 being outstanding. The measure is a dichotomized score. Participants who reported a "10" on all 3 items were "topscored" into one group; everyone else were categorized into another group. The number of participants who gave a topscore (a "10" for all 3 items) was reported.'}, {'measure': 'SDM Process Scale', 'timeFrame': 'Within 1 day', 'description': 'Four items that measures the amount of shared decision making that occurs in an interaction. Total scores ranged from 0-4, with higher scores indicating more shared decision making occurred.'}, {'measure': 'MD Perceptions of Length of Visit', 'timeFrame': 'Within 1 day', 'description': 'One item assessed how physician felt about the length of the visit. Responses were: Shorter than normal, About normal, Longer than normal. Number of physicians who responded that the visit was "shorter than normal" or "about normal" is reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['shared decision making'], 'conditions': ['Pelvic Organ Prolapse', 'Stress Urinary Incontinence', 'Overactive Bladder']}, 'referencesModule': {'references': [{'pmid': '34905749', 'type': 'DERIVED', 'citation': 'Marques F, Josloff K, Hung K, Wakamatsu M, Sepucha KR. Decision aids and shared decision making in urogynecology. Menopause. 2021 Dec 13;29(2):178-183. doi: 10.1097/GME.0000000000001901.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate how patient knowledge and confidence in decision making can be impacted by shared decision making in common urogynecology conditions.', 'detailedDescription': "The investigators will enroll patients seeing a specialist to discuss treatment of pelvic organ prolapse, overactive bladder and stress urinary incontinence in this pilot study. The study will evaluate the feasibility and acceptability of three decision aids designed to promote shared decision making conversations for these three condition. The investigators use a quasi-experimental design in which the investigators first enroll patients in the control arm and measure their outcomes. Then, the investigators enroll patients into the intervention arm and measure their outcomes. The investigators estimate that it will take about one month to recruit the control arm and one month to recruit the intervention arm. Patients will be surveyed after the clinic visit with a specialist and surveys will assess patients' knowledge, treatment preferences, shared decision making, decisional conflict and acceptability of the tool. A clinician survey will be administered and completed after each patient visit, that details how the physician felt about the length of the visit, how informed the patient was, and how far along they may be with their decision."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': "Recruiting only female patients as Urogynecology conditions only affect women's pelvic organs and pelvic floor.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18-95 years only\n* English speaking\n* Pelvic organ prolapse defined by noticeable (to the patient) vaginal bulging\n* Symptoms of stress urinary incontinence (cough, sneeze, laugh, exercise)\n* Presenting for initial consultation for either of the above symptoms\n\nExclusion Criteria:\n\n* Primary complaint is not vaginal bulging or stress urinary incontinence\n* Prior surgery for pelvic organ prolapse or any incontinence procedure'}, 'identificationModule': {'nctId': 'NCT04369404', 'briefTitle': 'Impact of Decision Aids in Urogynecology', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Impact of Decision Aids in Urogynecology', 'orgStudyIdInfo': {'id': '2017P001883 - 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'In the usual care group, the providers do not have access to the decision aids.'}, {'type': 'EXPERIMENTAL', 'label': 'Patient Decision Aid', 'description': 'Providers have access to patient decision aids to review and discuss during the visit.', 'interventionNames': ['Behavioral: Pelvic organ prolapse decision aid', 'Behavioral: Stress urinary incontinence decision aid', 'Behavioral: Overactive bladder decision aid']}], 'interventions': [{'name': 'Pelvic organ prolapse decision aid', 'type': 'BEHAVIORAL', 'description': 'Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse', 'armGroupLabels': ['Patient Decision Aid']}, {'name': 'Stress urinary incontinence decision aid', 'type': 'BEHAVIORAL', 'description': 'Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.', 'armGroupLabels': ['Patient Decision Aid']}, {'name': 'Overactive bladder decision aid', 'type': 'BEHAVIORAL', 'description': 'Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.', 'armGroupLabels': ['Patient Decision Aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Karen Sepucha, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Health Decision Sciences Center', 'investigatorFullName': 'Karen Sepucha', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}