Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:41 PM
Study NCT ID:
NCT04295135
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2020-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Chronic Pain OneSheet Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'charle@iu.edu', 'phone': '317 278 3245', 'title': 'Dr. Christopher A. Harle', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '18 month treatment period', 'eventGroups': [{'id': 'EG000', 'title': 'OneSheet Access', 'description': 'PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.\n\nChronic Pain OneSheet: The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. OneSheet works by aggregating and structuring information that is already collected, that PCPs often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of OneSheet is to make the information that is important in clinical decision making more readily available, and to reduce the amount of time that PCPs need to spend locating this information.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Practice', 'description': 'PCPs who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain and Function Goal-setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '252625', 'groupId': 'OG000'}, {'value': '220179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OneSheet Access', 'description': 'PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.\n\nChronic Pain OneSheet: The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. OneSheet works by aggregating and structuring information that is already collected, that PCPs often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of OneSheet is to make the information that is important in clinical decision making more readily available, and to reduce the amount of time that PCPs need to spend locating this information.'}, {'id': 'OG001', 'title': 'Normal Practice', 'description': 'PCPs who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.'}], 'classes': [{'title': 'Pre OneSheet Go-Live', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '107114', 'groupId': 'OG000'}, {'value': '93111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0081', 'spread': '0.0898', 'groupId': 'OG000'}, {'value': '0.0016', 'spread': '0.0404', 'groupId': 'OG001'}]}]}, {'title': 'Post OneSheet Go-Live', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '145511', 'groupId': 'OG000'}, {'value': '127068', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0364', 'spread': '0.1873', 'groupId': 'OG000'}, {'value': '0.0283', 'spread': '0.1659', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.002', 'pValueComment': 'A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.001', 'estimateComment': 'The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model also included an interaction term for treatment and post-OneSheet access.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline (looked back at previous 12 months) and 18-month treatment period', 'description': "Proportion of visits for patients with chronic pain for whom the PCP documented pain and/or function goals in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse.", 'unitOfMeasure': 'Proportion of patient visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Patient visits', 'denomUnitsSelected': 'Patient visits', 'populationDescription': 'PCPs enrolled during both recruitment phases and their visits with adult patients with chronic pain starting at the baseline (looked back at previous 12 months; pre-OneSheet Go-Live) and 18-month treatment period (post-OneSheet Go-Live).'}, {'type': 'PRIMARY', 'title': 'Pain, Enjoyment of Life, and General Activity (PEG) Documentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '252625', 'groupId': 'OG000'}, {'value': '220179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OneSheet Access', 'description': 'PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.\n\nChronic Pain OneSheet: The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. OneSheet works by aggregating and structuring information that is already collected, that PCPs often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of OneSheet is to make the information that is important in clinical decision making more readily available, and to reduce the amount of time that PCPs need to spend locating this information.'}, {'id': 'OG001', 'title': 'Normal Practice', 'description': 'PCPs who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.'}], 'classes': [{'title': 'Pre OneSheet Go-Live', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '107114', 'groupId': 'OG000'}, {'value': '93111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0086', 'spread': '0.0923', 'groupId': 'OG000'}, {'value': '0.0096', 'spread': '0.0973', 'groupId': 'OG001'}]}]}, {'title': 'Post OneSheet Go-Live', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '145511', 'groupId': 'OG000'}, {'value': '127068', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0313', 'spread': '0.1741', 'groupId': 'OG000'}, {'value': '0.0253', 'spread': '0.1572', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.007', 'pValueComment': 'A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.001', 'estimateComment': 'The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model also included an interaction term for treatment and post-OneSheet access.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline (looked back at previous 12 months) and 18-month treatment period', 'description': "Proportion of visits for patients with chronic pain for whom the PCP documented the assessment of pain and/or function (e.g. Pain, Enjoyment, General Activity (PEG) scale in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse. The PEG has a scale of 1-10, and is used to track an individual's changes over time. With effective therapy, an individual's score should decrease over time.", 'unitOfMeasure': 'Proportion of patient visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Patient visits', 'denomUnitsSelected': 'Patient visits', 'populationDescription': 'PCPs enrolled during both recruitment phases and their visits with adult patients with chronic pain starting at the baseline (looked back at previous 12 months; pre-OneSheet Go-Live) and 18-month treatment period (post-OneSheet Go-Live).'}, {'type': 'PRIMARY', 'title': 'Urine Drug Screening (UDS) Results Ordered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '26942', 'groupId': 'OG000'}, {'value': '23492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OneSheet Access', 'description': 'PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.\n\nChronic Pain OneSheet: The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. OneSheet works by aggregating and structuring information that is already collected, that PCPs often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of OneSheet is to make the information that is important in clinical decision making more readily available, and to reduce the amount of time that PCPs need to spend locating this information.'}, {'id': 'OG001', 'title': 'Normal Practice', 'description': 'PCPs who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.'}], 'classes': [{'title': 'Pre OneSheet Go-Live', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '11462', 'groupId': 'OG000'}, {'value': '10492', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4175', 'spread': '0.4932', 'groupId': 'OG000'}, {'value': '0.5486', 'spread': '0.4977', 'groupId': 'OG001'}]}]}, {'title': 'Post OneSheet Go-Live', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '15480', 'groupId': 'OG000'}, {'value': '13000', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3746', 'spread': '0.4840', 'groupId': 'OG000'}, {'value': '0.4705', 'spread': '0.4991', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.022', 'pValueComment': 'A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.008', 'estimateComment': 'The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model also included an interaction term for treatment and post-OneSheet access.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline (looked back at previous 12 months) and 18-month treatment period', 'description': "Proportion of visits for patients with chronic pain on long term opioid therapy (LTOT) for whom the PCP ordered a UDS, as assessed by data extracted from the healthcare systems' clinical data warehouse.", 'unitOfMeasure': 'Proportion of patient visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Patient visits', 'denomUnitsSelected': 'Patient visits', 'populationDescription': 'PCPs enrolled during both recruitment phases and their visits with adult patients with chronic pain on LTOT starting at the baseline (looked back at previous 12 months; pre-OneSheet Go-Live) and 18-month treatment period (post-OneSheet Go-Live). The number of units (patient visits and participant counts) analyzed differs between the pre-OneSheet Go-Live and post-OneSheet Go-Live periods due to some PCPs only having qualifying visits in either the pre- or post- intervention period.'}, {'type': 'PRIMARY', 'title': 'Prescription Drug Monitoring Program (PDMP) Reports Reviewed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '26942', 'groupId': 'OG000'}, {'value': '23492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OneSheet Access', 'description': 'PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.\n\nChronic Pain OneSheet: The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. OneSheet works by aggregating and structuring information that is already collected, that PCPs often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of OneSheet is to make the information that is important in clinical decision making more readily available, and to reduce the amount of time that PCPs need to spend locating this information.'}, {'id': 'OG001', 'title': 'Normal Practice', 'description': 'PCPs who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.'}], 'classes': [{'title': 'Pre OneSheet Go-Live', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '11462', 'groupId': 'OG000'}, {'value': '10492', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7457', 'spread': '0.4355', 'groupId': 'OG000'}, {'value': '0.7962', 'spread': '0.4028', 'groupId': 'OG001'}]}]}, {'title': 'Post OneSheet Go-Live', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '15480', 'groupId': 'OG000'}, {'value': '13000', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8008', 'spread': '0.3994', 'groupId': 'OG000'}, {'value': '0.8461', 'spread': '0.3609', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.005', 'pValueComment': 'A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.006', 'estimateComment': 'The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model also included an interaction term for treatment and post-OneSheet access.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline (looked back at previous 12 months) and 18-month treatment period', 'description': "Proportion of visits for patients with chronic pain on LTOT for whom the PCP accessed the PDMP report, as assessed by data extracted from the healthcare systems' clinical data warehouse.", 'unitOfMeasure': 'Proportion of patient visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Patient visits', 'denomUnitsSelected': 'Patient visits', 'populationDescription': 'PCPs enrolled during both recruitment phases and their visits with adult patients with chronic pain on LTOT starting at the baseline (looked back at previous 12 months; pre-OneSheet Go-Live) and 18-month treatment period (post-OneSheet Go-Live). The number of units (patient visits and participant counts) analyzed differs between the pre-OneSheet Go-Live and post-OneSheet Go-Live periods due to some PCPs only having qualifying visits in either the pre- or post- intervention period.'}, {'type': 'SECONDARY', 'title': 'Naloxone Prescriptions Ordered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '26942', 'groupId': 'OG000'}, {'value': '23492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OneSheet Access', 'description': 'PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.\n\nChronic Pain OneSheet: The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. OneSheet works by aggregating and structuring information that is already collected, that PCPs often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of OneSheet is to make the information that is important in clinical decision making more readily available, and to reduce the amount of time that PCPs need to spend locating this information.'}, {'id': 'OG001', 'title': 'Normal Practice', 'description': 'PCPs who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.'}], 'classes': [{'title': 'Pre OneSheet Go-Live', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '11462', 'groupId': 'OG000'}, {'value': '10492', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0012', 'spread': '0.0349', 'groupId': 'OG000'}, {'value': '0.0004', 'spread': '0.0195', 'groupId': 'OG001'}]}]}, {'title': 'Post OneSheet Go-Live', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '15480', 'groupId': 'OG000'}, {'value': '13000', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0054', 'spread': '0.0730', 'groupId': 'OG000'}, {'value': '0.0090', 'spread': '0.0944', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.005', 'pValueComment': 'A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.001', 'estimateComment': 'The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model also included an interaction term for treatment and post-OneSheet access.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline (looked back at previous 12 months) and 18-month treatment period', 'description': "Proportion of visits for patients with chronic pain on LTOT for whom the PCP ordered naloxone, as assessed by data extracted from the healthcare systems' clinical data warehouse.", 'unitOfMeasure': 'Proportion of patient visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Patient visits', 'denomUnitsSelected': 'Patient visits', 'populationDescription': 'PCPs enrolled during both recruitment phases and their visits with adult patients with chronic pain on LTOT starting at the baseline (looked back at previous 12 months; pre-OneSheet Go-Live) and 18-month treatment period (post-OneSheet Go-Live). The number of units (patient visits and participant counts) analyzed differs between the pre-OneSheet Go-Live and post-OneSheet Go-Live periods due to some PCPs only having qualifying visits in either the pre- or post- intervention period.'}, {'type': 'SECONDARY', 'title': 'Medications for Opioid Use Disorder Prescription Ordered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '26942', 'groupId': 'OG000'}, {'value': '23492', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OneSheet Access', 'description': 'PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.\n\nChronic Pain OneSheet: The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. OneSheet works by aggregating and structuring information that is already collected, that PCPs often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of OneSheet is to make the information that is important in clinical decision making more readily available, and to reduce the amount of time that PCPs need to spend locating this information.'}, {'id': 'OG001', 'title': 'Normal Practice', 'description': 'PCPs who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.'}], 'classes': [{'title': 'Pre OneSheet Go-Live', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '11462', 'groupId': 'OG000'}, {'value': '10492', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0119', 'spread': '0.1083', 'groupId': 'OG000'}, {'value': '0.0092', 'spread': '0.0957', 'groupId': 'OG001'}]}]}, {'title': 'Post OneSheet Go-Live', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'units': 'Patient visits', 'counts': [{'value': '15480', 'groupId': 'OG000'}, {'value': '13000', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0383', 'spread': '0.1919', 'groupId': 'OG000'}, {'value': '0.0373', 'spread': '0.1895', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.002', 'pValueComment': 'A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.003', 'estimateComment': 'The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model also included an interaction term for treatment and post-OneSheet access.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline (looked back at previous 12 months) and 18-month treatment period', 'description': "Proportion of visits for patients with chronic pain on LTOT for whom the PCP ordered a medication for opioid use disorder, as assessed by data extracted from the healthcare systems' clinical data warehouse.", 'unitOfMeasure': 'Proportion of patient visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Patient visits', 'denomUnitsSelected': 'Patient visits', 'populationDescription': 'PCPs enrolled during both recruitment phases and their visits with adult patients with chronic pain on LTOT starting at the baseline (looked back at previous 12 months; pre-OneSheet Go-Live) and 18-month treatment period (post-OneSheet Go-Live). The number of units (patient visits and participant counts) analyzed differs between the pre-OneSheet Go-Live and post-OneSheet Go-Live periods due to some PCPs only having qualifying visits in either the pre- or post- intervention period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OneSheet Access', 'description': 'PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.\n\nChronic Pain OneSheet: The Chronic Pain OneSheet (OneSheet) is an electronic health record (EHR) decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. OneSheet works by aggregating and structuring information that is already collected, that PCPs often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of OneSheet is to make the information that is important in clinical decision making more readily available, and to reduce the amount of time that PCPs need to spend locating this information.'}, {'id': 'FG001', 'title': 'Normal Practice', 'description': 'PCPs who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '64 PCPs were enrolled in the OneSheet Access group during recruitment phase #1. 5 PCPs were added in recruitment phase #2', 'groupId': 'FG000', 'numSubjects': '69'}, {'comment': '63 PCPs were enrolled to the Normal Practice group during recruitment phase #1. 5 PCPs were added in recruitment phase #2.', 'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject left organization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Primary care providers (PCP) were recruited after virtual staff meetings. PCP recruitment occurred in two phases: Phase 1(health system 1: Aug-Oct 2020; health system 2: Sept-Nov 2020) and Phase 2 (Sep-Dec 2021). Phase 2 recruited more PCPs to increase the sample size and allow new PCPs to participate. PCPs were randomly assigned to either a treatment or a control group (permanent assignment). We combined data from PCPs recruited in both phases for analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OneSheet Access', 'description': 'PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.\n\nChronic Pain OneSheet: The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. OneSheet works by aggregating and structuring information that is already collected, that PCPs often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of OneSheet is to make the information that is important in clinical decision making more readily available, and to reduce the amount of time that PCPs need to spend locating this information.'}, {'id': 'BG001', 'title': 'Normal Practice', 'description': 'PCPs who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', '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': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', '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': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Years practicing medicine', 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '9.94', 'groupId': 'BG000'}, {'value': '9.7', 'spread': '9.39', 'groupId': 'BG001'}, {'value': '10.0', 'spread': '9.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-09', 'size': 291914, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-07T11:22', 'hasProtocol': True}, {'date': '2024-03-05', 'size': 262510, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-07T11:48', 'hasProtocol': False}, {'date': '2021-07-27', 'size': 279567, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-10T16:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'dispFirstSubmitDate': '2022-11-21', 'completionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2020-02-15', 'dispFirstSubmitQcDate': '2022-11-21', 'resultsFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2020-03-02', 'dispFirstPostDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-22', 'studyFirstPostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain and Function Goal-setting', 'timeFrame': 'Assessed at baseline (looked back at previous 12 months) and 18-month treatment period', 'description': "Proportion of visits for patients with chronic pain for whom the PCP documented pain and/or function goals in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse."}, {'measure': 'Pain, Enjoyment of Life, and General Activity (PEG) Documentation', 'timeFrame': 'Assessed at baseline (looked back at previous 12 months) and 18-month treatment period', 'description': "Proportion of visits for patients with chronic pain for whom the PCP documented the assessment of pain and/or function (e.g. Pain, Enjoyment, General Activity (PEG) scale in the EHR, as assessed by data extracted from the healthcare systems' clinical data warehouse. The PEG has a scale of 1-10, and is used to track an individual's changes over time. With effective therapy, an individual's score should decrease over time."}, {'measure': 'Urine Drug Screening (UDS) Results Ordered', 'timeFrame': 'Assessed at baseline (looked back at previous 12 months) and 18-month treatment period', 'description': "Proportion of visits for patients with chronic pain on long term opioid therapy (LTOT) for whom the PCP ordered a UDS, as assessed by data extracted from the healthcare systems' clinical data warehouse."}, {'measure': 'Prescription Drug Monitoring Program (PDMP) Reports Reviewed', 'timeFrame': 'Assessed at baseline (looked back at previous 12 months) and 18-month treatment period', 'description': "Proportion of visits for patients with chronic pain on LTOT for whom the PCP accessed the PDMP report, as assessed by data extracted from the healthcare systems' clinical data warehouse."}], 'secondaryOutcomes': [{'measure': 'Naloxone Prescriptions Ordered', 'timeFrame': 'Assessed at baseline (looked back at previous 12 months) and 18-month treatment period', 'description': "Proportion of visits for patients with chronic pain on LTOT for whom the PCP ordered naloxone, as assessed by data extracted from the healthcare systems' clinical data warehouse."}, {'measure': 'Medications for Opioid Use Disorder Prescription Ordered', 'timeFrame': 'Assessed at baseline (looked back at previous 12 months) and 18-month treatment period', 'description': "Proportion of visits for patients with chronic pain on LTOT for whom the PCP ordered a medication for opioid use disorder, as assessed by data extracted from the healthcare systems' clinical data warehouse."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical Decision Support', 'Chronic pain care', 'Behavioral Economics', 'Provider behavior'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '35484491', 'type': 'DERIVED', 'citation': 'Mazurenko O, Sanner L, Apathy NC, Mamlin BW, Menachemi N, Adams MCB, Hurley RW, Erazo SF, Harle CA. Evaluation of electronic recruitment efforts of primary care providers as research subjects during the COVID-19 pandemic. BMC Prim Care. 2022 Apr 28;23(1):95. doi: 10.1186/s12875-022-01705-y.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether and how having access to the Chronic Pain OneSheet clinical decision support tool in Epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome measuring behavior of participating primary care providers (PCPs) in visits with patients with chronic pain conditions. The investigators will also assess whether access to the Chronic Pain OneSheet results in PCPs making chronic pain treatment decisions that are more concordant with the Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain.', 'detailedDescription': "The Chronic Pain OneSheet (OneSheet) is an electronic health record (EHR) based clinical support tool developed and built in Epic. The OneSheet is a dashboard designed to assist PCPs in treating patients with chronic pain conditions by providing an overview of patient information needed by PCPs when treating these patients. The dashboard does not provide new information to PCPs. Instead, it works by aggregating and structuring information already being collected, available in other places in the medical record. By aggregating and structuring this information more conveniently, the goal of the OneSheet is to make important information in clinical decision-making more readily available and reduce the time PCPs need to spend locating this information.\n\nThe study aimed to determine whether and how having access to the Chronic Pain OneSheet activity in Epic affects the ordering, prescribing, goal-setting, risk monitoring, and outcome-measuring behavior of participating PCPs in visits with patients with chronic pain conditions. The investigators also assessed whether access to the Chronic Pain OneSheet results in PCPs making chronic pain treatment decisions that are more concordant with the CDC Guideline for Prescribing Opioids for Chronic Pain.\n\nTo test this, researchers conducted a two-arm pragmatic randomized controlled trial (RCT), enrolling PCPs across two health systems. The randomization occurred at the PCP level; the analysis occurred at the patient-visit level. The PCPs signed an informed consent form, while the data from patient visits was obtained through a waiver of informed consent. The investigators assessed outcomes by analyzing EHR usage log files and PCP ordering records extracted from the healthcare systems' clinical data warehouses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary care provider (including Family Medicine, Internal Medicine, Med-Peds, and General Medicine)\n* Can prescribe medication (i.e., Doctor of Medicine (MD), Nurse Practitioner (NP), Physicians Assistant (PA))\n* Sees patients at a primary care clinic at one of the two participating hospital systems\n\nExclusion Criteria:\n\n* Does not practice primary care\n* Does not regularly see patients at a primary care clinic at one of the two participating hospital systems\n* Cannot prescribe medication'}, 'identificationModule': {'nctId': 'NCT04295135', 'briefTitle': 'Chronic Pain OneSheet Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Nudging Primary Care Providers Toward Guideline-Recommended Opioid Prescribing Through Easier and More Convenient EHR Information Design', 'orgStudyIdInfo': {'id': '1911922583'}, 'secondaryIdInfos': [{'id': '5R33DA046085-05', 'link': 'https://reporter.nih.gov/quickSearch/5R33DA046085-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OneSheet access', 'description': 'PCPs who receive access to, and training in the Chronic Pain OneSheet, and use it while caring for patients with chronic pain.', 'interventionNames': ['Behavioral: Chronic Pain OneSheet']}, {'type': 'NO_INTERVENTION', 'label': 'Normal practice', 'description': 'PCPs who do not receive access to, or training in the Chronic Pain OneSheet, and care for patients with chronic pain as they would normally.'}], 'interventions': [{'name': 'Chronic Pain OneSheet', 'type': 'BEHAVIORAL', 'otherNames': ['Pain Dashboard'], 'description': 'The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. OneSheet works by aggregating and structuring information that is already collected, that PCPs often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of OneSheet is to make the information that is important in clinical decision making more readily available, and to reduce the amount of time that PCPs need to spend locating this information.', 'armGroupLabels': ['OneSheet access']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '27109', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Christopher A Harle, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'Olena Mazurenko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eskenazi Health', 'class': 'OTHER'}, {'name': 'Wake Forest University', 'class': 'OTHER'}, {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, {'name': 'University of Florida', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Olena Mazurenko', 'investigatorAffiliation': 'Indiana University'}}}}