Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT05065502
Status:
COMPLETED
Last Update Posted:
2025-10-15
First Post:
2021-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
MIDAS Cluster Randomized Controlled Trial of Implementation Strategies to Optimize Use of Medications in VA Clinical Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jeremy.Sussman@va.gov', 'phone': 'N/A', 'title': 'Jeremy Sussman, MD, MS, Corresponding Principal Investigator', 'organization': 'VA Ann Arbor Health Care System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This evaluation was developed by combining three smaller cluster randomized control trials on different topic areas. In the early post-coronavirus disease 2019 (COVID-19) era, site-level engagement was extremely difficult, perhaps minimizing the impact of the interventions.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were not monitored. Not applicable.', 'description': 'Adverse events were not monitored. Not applicable.', 'eventGroups': [{'id': 'EG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. (PMID: 35568903)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. (PMID: 35568903) LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. (PMID: 32901440)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Percentage of Patients With Potentially Inappropriate Medication Use (PIMs) Between Pre- and Post-periods, Across Facilities.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120,891', 'groupId': 'OG000'}, {'value': '96,117', 'groupId': 'OG001'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.133', 'groupId': 'OG000', 'lowerLimit': '-0.481', 'upperLimit': '0.2144'}, {'value': '-0.395', 'groupId': 'OG001', 'lowerLimit': '-0.800', 'upperLimit': '0.0104'}]}]}], 'analyses': [{'pValue': '0.273', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.261', 'ciLowerLimit': '-0.728', 'ciUpperLimit': '0.206', 'pValueComment': 'Significance level is set at 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.238', 'estimateComment': 'Between-arm difference at 13-18 months post-baseline, controlling for rates 1-6 months pre-baseline', 'groupDescription': "Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of PIMs of post-intervention period (months 13 to 18), controlling for use in pre-baseline period (months 0 to 6), averaged across three studies.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '13-18 months post-baseline', 'description': 'Percentage of PIMs across AD vs. LEAP+AD facilities were modelled as the difference between post-period and pre-period, using the average from the 1-6-month pre-baseline period as "pre" and the average 13-18-month post-baseline as "post." Data was collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Clinic-month outcome was computed as: 1) VIONE; proportion of patients who possessed one or more medications from the Beers\' list of patients 65 or older, actively following with the clinic, and not in hospice/palliative care; 2) DOACs; proportion of patients with flags for potentially inappropriate use on a DOAC safety dashboard of those using DOACs; 3) CBTI; proportion of patients with a new prescription for a sleep medication for insomnia who have not had CBTI of those who are actively followed by the clinic and not in hospice/palliative care. The outcome was analyzed by pooling across all three-EBPs.', 'unitOfMeasure': 'percentage of patients with PIMs', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'VA medical centers and/or clinics', 'denomUnitsSelected': 'VA medical centers and/or clinics', 'populationDescription': 'The number of participants analyzed refers to all individuals who were eligible for the cross sectional analysis at any time point in the study .'}, {'type': 'SECONDARY', 'title': 'Change in Patients With Percentage of Potentially Inappropriate Use of Medications (PIMs) Across Facilities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19,369', 'groupId': 'OG000'}, {'value': '8,130', 'groupId': 'OG001'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01756', 'groupId': 'OG000', 'lowerLimit': '-0.03052', 'upperLimit': '-0.00459'}, {'value': '-0.01618', 'groupId': 'OG001', 'lowerLimit': '-0.03854', 'upperLimit': '0.00619'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00138', 'ciLowerLimit': '-0.0245', 'ciUpperLimit': '0.0272', 'groupDescription': "Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of PIMs for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '13-18 months post-baseline', 'description': 'Medications include proton pump inhibitors (PPIs), aspirin, central nervous system (CNS) active medications (muscle relaxants, anti-psychotics, Z-drugs, and benzodiazepines), or anticholinergic drugs. This is the primary outcome for the VIONE trial when analyzed as a stand-alone trial and the VIONE sub-analysis of the overall MIDAS study primary outcome. Percentage of patients with PIMs across AD vs. LEAP+AD facilities were modelled longitudinally using Generalized Estimating Equations (GEE), with a three way-interaction of arm, month of follow-up, and pre-, post-period. Data will was be collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Estimates computed using least squares (LS) means from the GEE model.', 'unitOfMeasure': 'percentage of patients with PIMs', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'VA medical centers and/or clinics', 'denomUnitsSelected': 'VA medical centers and/or clinics', 'populationDescription': 'The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the VIONE study.'}, {'type': 'SECONDARY', 'title': 'Change in Monthly Medication Costs for All Drugs Across Facilities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19,369', 'groupId': 'OG000'}, {'value': '8,130', 'groupId': 'OG001'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. ='}], 'classes': [{'categories': [{'measurements': [{'value': '70.73', 'groupId': 'OG000', 'lowerLimit': '34.94', 'upperLimit': '106.52'}, {'value': '13.72', 'groupId': 'OG001', 'lowerLimit': '-29.76', 'upperLimit': '57.19'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23', 'ciLowerLimit': '-23.3', 'ciUpperLimit': '69.3', 'estimateComment': 'Statistical Assumptions for Valid Inference of a typical Difference-in-Difference model were not met, Estimate computed from modelling Post-period, and adjusting for Pre-period.', 'groupDescription': "Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in medication costs from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18).", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '13-18 months post-baseline', 'description': 'Cost of all drugs without regard to appropriateness. Average monthly cost per patient across LEAP vs. LEAP + AD facilities were modelled longitudinally with a Generalized Linear Model with a Gamma Link and a three-way interaction of arm, month of follow-up and pre-, post-period. Estimates computed using LS means from the GEE model. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial.', 'unitOfMeasure': 'dollars per patient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'VA medical centers and/or clinics', 'denomUnitsSelected': 'VA medical centers and/or clinics', 'populationDescription': 'The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the VIONE study.'}, {'type': 'SECONDARY', 'title': 'Change in Number of Medication Reviews Across Facilities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19,369', 'groupId': 'OG000'}, {'value': '8,130', 'groupId': 'OG001'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.00004', 'groupId': 'OG000', 'lowerLimit': '-0.00011', 'upperLimit': '0.00002'}, {'value': '-0.00064', 'groupId': 'OG001', 'lowerLimit': '-0.00112', 'upperLimit': '-0.00017'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.599', 'ciLowerLimit': '-1.080', 'ciUpperLimit': '-0.122', 'groupDescription': "Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in count of medication note reviews from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18).", 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Medication reviews per 1,000 patients (outcome multiplied by 1,000).\n\nStatistical Assumptions for Valid Inference of a typical Difference-in-Difference model were not met, Estimate computed from modelling Post-period, and adjusting for Pre-period.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '13-18 months post-baseline', 'description': 'Number of medication reviews completed by a pharmacist. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial.', 'unitOfMeasure': 'number of medication reviews', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'VA medical centers and/or clinics', 'denomUnitsSelected': 'VA medical centers and/or clinics', 'populationDescription': 'The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the VIONE study.'}, {'type': 'SECONDARY', 'title': 'Change in Number of Inappropriate Medications at a Patient-level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19369', 'groupId': 'OG000'}, {'value': '8130', 'groupId': 'OG001'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.00625', 'groupId': 'OG000', 'lowerLimit': '-0.03369', 'upperLimit': '0.02118'}, {'value': '-0.05942', 'groupId': 'OG001', 'lowerLimit': '-0.08509', 'upperLimit': '-0.03376'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05317', 'ciLowerLimit': '-0.09073', 'ciUpperLimit': '0.01561', 'groupDescription': "Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in count of inappropriate use from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18)", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '13-18 months post-baseline', 'description': 'This is a measure of count of medications used at the patient (not facility) level. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial.', 'unitOfMeasure': 'percentage of patients with PIMs', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'VA medical centers and/or clinics', 'denomUnitsSelected': 'VA medical centers and/or clinics', 'populationDescription': 'The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the VIONE study.'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Patients With High-risk Direct Oral Anticoagulant (DOAC) Use Across Facilities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17398', 'groupId': 'OG000'}, {'value': '14495', 'groupId': 'OG001'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.64', 'groupId': 'OG000', 'lowerLimit': '-0.38', 'upperLimit': '1.66'}, {'value': '0.53', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '1.37'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-1.44', 'ciUpperLimit': '1.20', 'groupDescription': "Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of high-risk DOAC use from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18).", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '13-18 months post-baseline', 'description': 'High-risk DOAC use will be assessed by "flags" using the algorithm from an operations DOAC dashboard. These flags were developed based on existing guidelines and advice of many anticoagulation experts. Percentage of patients with PIMs across AD vs. LEAP+AD facilities were modelled longitudinally using Generalized Estimating Equations, with a three way-interaction of arm, month of follow-up, and pre-, post-period. Data will was be collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Estimates computed using LS means from the GEE model. This is the primary outcome for the DOAC trial when analyzed as a stand-alone trial and the DOAC sub-analysis of the overall MIDAS study primary outcome.', 'unitOfMeasure': 'percentage of patients with a DOAC flag', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'VA medical centers and/or clinics', 'denomUnitsSelected': 'VA medical centers and/or clinics', 'populationDescription': 'The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the DOAC study.'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Chronic Kidney Disease Across Facilities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17398', 'groupId': 'OG000'}, {'value': '14495', 'groupId': 'OG001'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '0.75'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '-0.33', 'upperLimit': '0.55'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '0.42', 'groupDescription': "Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of of high-risk DOAC use attributable to chronic kidney disease for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6), ), controlling for the pre-baseline period (months 0 to 6).", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '13-18 months post-baseline', 'description': 'This was the subset of patients with DOAC Population Health Management Tool (Dashboard) flags that occur when medications are given at doses that would be appropriate but are not because the patient has abnormal renal function. This has had minimal adjustments since being described in previous publications.', 'unitOfMeasure': 'percentage of patients with a DOAC flag', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'VA medical centers and/or clinics', 'denomUnitsSelected': 'VA medical centers and/or clinics', 'populationDescription': 'The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the DOAC study.'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Weight Across Facilities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17398', 'groupId': 'OG000'}, {'value': '14495', 'groupId': 'OG001'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '-0.13', 'upperLimit': '0.47'}, {'value': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '0.76'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.72', 'groupDescription': "Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of high-risk DOAC use attributable to weight for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '13-18 months post-baseline', 'description': 'This was the subset of patients with DOAC Population Health Management Tool (Dashboard) flags that occur when medications are given at doses that would be appropriate but are not because the patient has unusually high or low weight or BMI. This has had minimal adjustments since being described in previous publications.', 'unitOfMeasure': 'percentage of patients with a DOAC flag', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'VA medical centers and/or clinics', 'denomUnitsSelected': 'VA medical centers and/or clinics', 'populationDescription': 'The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the DOAC study.'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Other Mis-dosing Across Facilities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17398', 'groupId': 'OG000'}, {'value': '14495', 'groupId': 'OG001'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '0.57'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '-0.34', 'upperLimit': '0.37'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '0.33', 'groupDescription': "Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of high-risk DOAC use attributable to mis-dosing for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '13-18 months post-baseline', 'description': 'These are the remaining high-risk flags and are usually due to patients with medication interactions or doses that are incorrect due to the indication. This has had minimal adjustments since being described in previous publications.', 'unitOfMeasure': 'percentage of patients with a DOAC flag', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'VA medical centers and/or clinics', 'denomUnitsSelected': 'VA medical centers and/or clinics', 'populationDescription': 'The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the DOAC study.'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Patient Receipt of Any Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90,307', 'groupId': 'OG000'}, {'value': '78,842', 'groupId': 'OG001'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.00922', 'groupId': 'OG000', 'lowerLimit': '-0.04200', 'upperLimit': '0.02355'}, {'value': '0.00085', 'groupId': 'OG001', 'lowerLimit': '-0.00898', 'upperLimit': '0.01067'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01007', 'ciLowerLimit': '-0.02415', 'ciUpperLimit': '0.04429', 'groupDescription': "Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of CBTI receipt for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6)", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '13-18 months post-baseline', 'description': 'Patient receipt of any CBTI will be measured by extracting from the medical records CBTI note templates completed by CBTI therapists. The denominator will consist of primary care patients who are not in hospice/palliative care. Percentage of PIMs across AD vs. LEAP+AD facilities were modelled longitudinally using Generalized Estimating Equations, with a three way-interaction of arm, month of follow-up, and pre-, post-period. Data will was be collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Estimates computed using LS means from the GEE model. This will be the primary outcome for the CBTI trial when analyzed as a stand-alone trial.', 'unitOfMeasure': 'percentage of patients receiving CBTI', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'VA medical centers and/or clinics', 'denomUnitsSelected': 'VA medical centers and/or clinics', 'populationDescription': 'The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the CBT-I study.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Cognitive Behavioral Therapy for Insomnia (CBTI) Sessions Completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'timeFrame': '13-18 months post-baseline', 'description': 'Mean number of sessions will be measured by extracting from the medical records CBTI note templates completed by CBTI therapists. The denominator will consist of primary care patients who are not in hospice/palliative care. This will be a secondary outcome for the CBTI trial when analyzed as a stand-alone trial.', 'reportingStatus': 'POSTED', 'populationDescription': 'After conducting additional testing of our algorithm for detecting CBTI sessions, we found the algorithm to be adequately sensitive to detecting \\*any\\* CBTI but not accurate for detecting the number of CBTI sessions (e.g., CBTI could often be mentioned in the context of a referral or some other ongoing treatment).'}, {'type': 'SECONDARY', 'title': 'Change in the Monthly Percentage of Patients Referred to Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'timeFrame': '13-18 months post-baseline', 'description': 'CBTI referrals will be measured according to counts of CBTI consult requests in the medical record. For clinics that do not use medical record consult requests specific to CBTI, referrals will be measured using monthly counts provided by CBTI therapists. The denominator will consist of primary care patients who are not in hospice/palliative care. This will be a secondary outcome for the CBTI trial when analyzed as a stand-alone trial.', 'reportingStatus': 'POSTED', 'populationDescription': "It was originally planned for all CBTI sites to provide information regarding where in the medical records the investigators could identify referrals. However, prior to launching the trial, it was determined several of the sites' processes for referrals were not distinguishable as referrals vs. other forms of communication (e.g., adding a therapist as a cosigner to a note), making collection of this data impractical and not conducted. Thus, we did not have any sites collect referral information."}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Patients With First Line Sleep Medication Across Facilities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90,307', 'groupId': 'OG000'}, {'value': '78,842', 'groupId': 'OG001'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. ='}], 'classes': [{'categories': [{'measurements': [{'value': '0.02206', 'groupId': 'OG000', 'lowerLimit': '-0.06155', 'upperLimit': '0.10567'}, {'value': '-0.06164', 'groupId': 'OG001', 'lowerLimit': '-0.15650', 'upperLimit': '0.03322'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0837', 'ciLowerLimit': '-0.21014', 'ciUpperLimit': '0.04275', 'groupDescription': "Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of PIMs for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '13-18 months post-baseline', 'description': 'The proportion of patients with a new prescription for a sleep medication for insomnia who have not had CBTI of those who are actively followed by the clinic and not in hospice/palliative care. This is a CBTI sub-analysis of the overall MIDAS study primary outcome.', 'unitOfMeasure': 'percentage of patients PIMs', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'VA medical centers and/or clinics', 'denomUnitsSelected': 'VA medical centers and/or clinics', 'populationDescription': 'The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the CBTI study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Employee Engagement in Quality Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.305', 'groupId': 'OG000', 'lowerLimit': '-0.242', 'upperLimit': '0.852'}, {'value': '0.247', 'groupId': 'OG001', 'lowerLimit': '-0.306', 'upperLimit': '0.801'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.102', 'ciLowerLimit': '-0.216', 'ciUpperLimit': '0.420', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '18-months Post-baseline', 'description': '3-item pilot measure of the extent to which employees engage in quality improvement activities given both at baseline and 18-months post-implementation. Scores are 1-5 with higher ratings indicating more engagement in quality improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants refers to those eligible for AD and/or LEAP participation at baseline and those who participated in AD and/or LEAP at post-implementation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Employee Burnout', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.586', 'groupId': 'OG000', 'lowerLimit': '-1.298', 'upperLimit': '0.127'}, {'value': '0.227', 'groupId': 'OG001', 'lowerLimit': '-0.441', 'upperLimit': '0.895'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0389', 'ciLowerLimit': '-0.555', 'ciUpperLimit': '0.477', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '18-months post-baseline', 'description': '3-item measure comprising one item each for exhaustion, depersonalization, and reduced achievement (reverse scored) given both at baseline and 18-months post-implementation. "High Burnout" measures the percent of staff who are feeling burned out on all three burnout items at a frequency of "once a week" to "every day." Scored: 0-100%, where LOWER score is more favorable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants refers to those eligible for AD and/or LEAP participation at baseline and/or those who participated in AD and/or LEAP at post-implementation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Best Places to Work Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.170', 'groupId': 'OG000', 'lowerLimit': '-0.412', 'upperLimit': '0.752'}, {'value': '-0.056', 'groupId': 'OG001', 'lowerLimit': '-0.636', 'upperLimit': '0.524'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.101', 'ciLowerLimit': '-0.250', 'ciUpperLimit': '0.452', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '18-months post-baseline', 'description': '3-item scale. "Best Places to Work" (BPTW) is a summary measure of the group\'s satisfaction with the job, organization, and likelihood to recommend VA as a good place to work given both at baseline and 18-months post-implementation. The values are 1 to 5 with a higher score being more positive and the BPTW score is the average of the 3 questions. This is a measure normally administered within the All-employee Survey (AES) and the questions come from the Partnership for Public Service\'s BPTW survey (http://bestplacestowork.org).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants refers to those eligible for AD and/or LEAP participation at baseline and those who participated in AD and/or LEAP at post-implementation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Workgroup Cohesion & Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'OG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.131', 'groupId': 'OG000', 'lowerLimit': '-0.348', 'upperLimit': '0.610'}, {'value': '0.152', 'groupId': 'OG001', 'lowerLimit': '-0.327', 'upperLimit': '0.631'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0428', 'ciLowerLimit': '-0.339', 'ciUpperLimit': '0.254', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '18-months post-baseline', 'description': "7-item measure from the VA's newly developed Patient Safety Culture given both at baseline and 18-months post-implementation. Values 1 to 5 where higher values indicate more positive scores.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants refers to those eligible for AD and/or LEAP participation at baseline and/or those who participated in AD and/or LEAP at post-implementation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'FG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The intervention was completed at the facility level.', 'groupId': 'FG000', 'numUnits': '14', 'numSubjects': 'NA'}, {'comment': 'The intervention was completed at the facility level.', 'groupId': 'FG001', 'numUnits': '14', 'numSubjects': 'NA'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'The intervention was completed at the facility level.', 'groupId': 'FG000', 'numUnits': '12', 'numSubjects': 'NA'}, {'comment': 'The intervention was completed at the facility level.', 'groupId': 'FG001', 'numUnits': '12', 'numSubjects': 'NA'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': 'NA'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': 'NA'}]}]}], 'typeUnitsAnalyzed': 'VA medical centers and/or clinics'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79481', 'groupId': 'BG000'}, {'value': '66208', 'groupId': 'BG001'}, {'value': '145689', 'groupId': 'BG002'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Academic Detailing (AD) Only', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.'}, {'id': 'BG001', 'title': 'AD + LEAP Combined', 'description': 'Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices.\n\nLEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79471', 'groupId': 'BG000'}, {'value': '66204', 'groupId': 'BG001'}, {'value': '145675', 'groupId': 'BG002'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'spread': '16.4', 'groupId': 'BG000'}, {'value': '66.3', 'spread': '15.9', 'groupId': 'BG001'}, {'value': '66.5', 'spread': '16.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The row population differs from the overall population because age was missing for some participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79471', 'groupId': 'BG000'}, {'value': '66204', 'groupId': 'BG001'}, {'value': '145675', 'groupId': 'BG002'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5201', 'groupId': 'BG000'}, {'value': '4162', 'groupId': 'BG001'}, {'value': '9363', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74270', 'groupId': 'BG000'}, {'value': '62042', 'groupId': 'BG001'}, {'value': '136312', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The row population differs from the overall population because sex was missing for some participants'}, {'title': 'Ethnicity (NIH/OMB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79481', 'groupId': 'BG000'}, {'value': '66208', 'groupId': 'BG001'}, {'value': '145689', 'groupId': 'BG002'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17593', 'groupId': 'BG000'}, {'value': '2078', 'groupId': 'BG001'}, {'value': '19671', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '59993', 'groupId': 'BG000'}, {'value': '62991', 'groupId': 'BG001'}, {'value': '122984', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1895', 'groupId': 'BG000'}, {'value': '1139', 'groupId': 'BG001'}, {'value': '3034', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79481', 'groupId': 'BG000'}, {'value': '66208', 'groupId': 'BG001'}, {'value': '145689', 'groupId': 'BG002'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '61865', 'groupId': 'BG000'}, {'value': '51216', 'groupId': 'BG001'}, {'value': '113081', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '9278', 'groupId': 'BG000'}, {'value': '6142', 'groupId': 'BG001'}, {'value': '15420', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '546', 'groupId': 'BG000'}, {'value': '1552', 'groupId': 'BG001'}, {'value': '2098', 'groupId': 'BG002'}]}]}, {'title': 'Hawaiian-Pacific', 'categories': [{'measurements': [{'value': '527', 'groupId': 'BG000'}, {'value': '563', 'groupId': 'BG001'}, {'value': '1090', 'groupId': 'BG002'}]}]}, {'title': 'Native-American/Alaskan Native', 'categories': [{'measurements': [{'value': '432', 'groupId': 'BG000'}, {'value': '746', 'groupId': 'BG001'}, {'value': '1178', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '6833', 'groupId': 'BG000'}, {'value': '5989', 'groupId': 'BG001'}, {'value': '12822', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Percent of Patients with Overall Inappropriate Medications across trials and facilities at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79481', 'groupId': 'BG000'}, {'value': '66208', 'groupId': 'BG001'}, {'value': '145689', 'groupId': 'BG002'}]}, {'units': 'VA medical centers and/or clinics', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '17.1', 'groupId': 'BG000'}, {'value': '14.1', 'spread': '19.1', 'groupId': 'BG001'}, {'value': '13.4', 'spread': '16.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Percentage of Patients with Potentially Inappropriate Medication use (PIMs) across all three trials/evidence based practices (EBPs) and Facilities, at baseline.', 'unitOfMeasure': 'Percent of patients with PIMs', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'VA medical centers and/or clinics'}], 'typeUnitsAnalyzed': 'VA medical centers and/or clinics', 'populationDescription': 'These numbers refer to all individuals who were eligible for each EBP at the baseline of the clinical trial.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-24', 'size': 366305, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-24T12:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The investigators will conduct a series of three trials to test two implementation strategies designed for sustained change. Each trial will be a two-arm, cluster-randomized trial. The results of these trials will be pooled together in a single cross-trial analysis using a dichotomous outcome for each trial. Each trial will also be analyzed independently. Two of the trials will use the same dichotomous primary outcome and the third trial will use a different primary outcome (CBTI). The two arms will both include use of clinical population health dashboards. Unit of analysis is clinic. Clinics will be randomized to one of two implementation strategies described below. Implementation strategies will be tested for effectiveness of sustained use of practices to address documented quality gaps related to (1) potentially inappropriate medications, (2) use of direct oral anticoagulation medications (DOACs), and (3) cognitive behavioral therapy as first-line treatment for insomnia (CBTI).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2021-08-17', 'resultsFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2021-09-28', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-24', 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Employee Engagement in Quality Improvement', 'timeFrame': '18-months Post-baseline', 'description': '3-item pilot measure of the extent to which employees engage in quality improvement activities given both at baseline and 18-months post-implementation. Scores are 1-5 with higher ratings indicating more engagement in quality improvement.'}, {'measure': 'Change in Employee Burnout', 'timeFrame': '18-months post-baseline', 'description': '3-item measure comprising one item each for exhaustion, depersonalization, and reduced achievement (reverse scored) given both at baseline and 18-months post-implementation. "High Burnout" measures the percent of staff who are feeling burned out on all three burnout items at a frequency of "once a week" to "every day." Scored: 0-100%, where LOWER score is more favorable.'}, {'measure': 'Change in Best Places to Work Score', 'timeFrame': '18-months post-baseline', 'description': '3-item scale. "Best Places to Work" (BPTW) is a summary measure of the group\'s satisfaction with the job, organization, and likelihood to recommend VA as a good place to work given both at baseline and 18-months post-implementation. The values are 1 to 5 with a higher score being more positive and the BPTW score is the average of the 3 questions. This is a measure normally administered within the All-employee Survey (AES) and the questions come from the Partnership for Public Service\'s BPTW survey (http://bestplacestowork.org).'}, {'measure': 'Change in Workgroup Cohesion & Engagement', 'timeFrame': '18-months post-baseline', 'description': "7-item measure from the VA's newly developed Patient Safety Culture given both at baseline and 18-months post-implementation. Values 1 to 5 where higher values indicate more positive scores."}], 'primaryOutcomes': [{'measure': 'Change in the Percentage of Patients With Potentially Inappropriate Medication Use (PIMs) Between Pre- and Post-periods, Across Facilities.', 'timeFrame': '13-18 months post-baseline', 'description': 'Percentage of PIMs across AD vs. LEAP+AD facilities were modelled as the difference between post-period and pre-period, using the average from the 1-6-month pre-baseline period as "pre" and the average 13-18-month post-baseline as "post." Data was collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Clinic-month outcome was computed as: 1) VIONE; proportion of patients who possessed one or more medications from the Beers\' list of patients 65 or older, actively following with the clinic, and not in hospice/palliative care; 2) DOACs; proportion of patients with flags for potentially inappropriate use on a DOAC safety dashboard of those using DOACs; 3) CBTI; proportion of patients with a new prescription for a sleep medication for insomnia who have not had CBTI of those who are actively followed by the clinic and not in hospice/palliative care. The outcome was analyzed by pooling across all three-EBPs.'}], 'secondaryOutcomes': [{'measure': 'Change in Patients With Percentage of Potentially Inappropriate Use of Medications (PIMs) Across Facilities', 'timeFrame': '13-18 months post-baseline', 'description': 'Medications include proton pump inhibitors (PPIs), aspirin, central nervous system (CNS) active medications (muscle relaxants, anti-psychotics, Z-drugs, and benzodiazepines), or anticholinergic drugs. This is the primary outcome for the VIONE trial when analyzed as a stand-alone trial and the VIONE sub-analysis of the overall MIDAS study primary outcome. Percentage of patients with PIMs across AD vs. LEAP+AD facilities were modelled longitudinally using Generalized Estimating Equations (GEE), with a three way-interaction of arm, month of follow-up, and pre-, post-period. Data will was be collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Estimates computed using least squares (LS) means from the GEE model.'}, {'measure': 'Change in Monthly Medication Costs for All Drugs Across Facilities', 'timeFrame': '13-18 months post-baseline', 'description': 'Cost of all drugs without regard to appropriateness. Average monthly cost per patient across LEAP vs. LEAP + AD facilities were modelled longitudinally with a Generalized Linear Model with a Gamma Link and a three-way interaction of arm, month of follow-up and pre-, post-period. Estimates computed using LS means from the GEE model. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial.'}, {'measure': 'Change in Number of Medication Reviews Across Facilities', 'timeFrame': '13-18 months post-baseline', 'description': 'Number of medication reviews completed by a pharmacist. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial.'}, {'measure': 'Change in Number of Inappropriate Medications at a Patient-level', 'timeFrame': '13-18 months post-baseline', 'description': 'This is a measure of count of medications used at the patient (not facility) level. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial.'}, {'measure': 'Change in Percentage of Patients With High-risk Direct Oral Anticoagulant (DOAC) Use Across Facilities', 'timeFrame': '13-18 months post-baseline', 'description': 'High-risk DOAC use will be assessed by "flags" using the algorithm from an operations DOAC dashboard. These flags were developed based on existing guidelines and advice of many anticoagulation experts. Percentage of patients with PIMs across AD vs. LEAP+AD facilities were modelled longitudinally using Generalized Estimating Equations, with a three way-interaction of arm, month of follow-up, and pre-, post-period. Data will was be collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Estimates computed using LS means from the GEE model. This is the primary outcome for the DOAC trial when analyzed as a stand-alone trial and the DOAC sub-analysis of the overall MIDAS study primary outcome.'}, {'measure': 'Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Chronic Kidney Disease Across Facilities', 'timeFrame': '13-18 months post-baseline', 'description': 'This was the subset of patients with DOAC Population Health Management Tool (Dashboard) flags that occur when medications are given at doses that would be appropriate but are not because the patient has abnormal renal function. This has had minimal adjustments since being described in previous publications.'}, {'measure': 'Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Weight Across Facilities', 'timeFrame': '13-18 months post-baseline', 'description': 'This was the subset of patients with DOAC Population Health Management Tool (Dashboard) flags that occur when medications are given at doses that would be appropriate but are not because the patient has unusually high or low weight or BMI. This has had minimal adjustments since being described in previous publications.'}, {'measure': 'Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Other Mis-dosing Across Facilities', 'timeFrame': '13-18 months post-baseline', 'description': 'These are the remaining high-risk flags and are usually due to patients with medication interactions or doses that are incorrect due to the indication. This has had minimal adjustments since being described in previous publications.'}, {'measure': 'Change in Percentage of Patient Receipt of Any Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities', 'timeFrame': '13-18 months post-baseline', 'description': 'Patient receipt of any CBTI will be measured by extracting from the medical records CBTI note templates completed by CBTI therapists. The denominator will consist of primary care patients who are not in hospice/palliative care. Percentage of PIMs across AD vs. LEAP+AD facilities were modelled longitudinally using Generalized Estimating Equations, with a three way-interaction of arm, month of follow-up, and pre-, post-period. Data will was be collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Estimates computed using LS means from the GEE model. This will be the primary outcome for the CBTI trial when analyzed as a stand-alone trial.'}, {'measure': 'Change in Mean Cognitive Behavioral Therapy for Insomnia (CBTI) Sessions Completed', 'timeFrame': '13-18 months post-baseline', 'description': 'Mean number of sessions will be measured by extracting from the medical records CBTI note templates completed by CBTI therapists. The denominator will consist of primary care patients who are not in hospice/palliative care. This will be a secondary outcome for the CBTI trial when analyzed as a stand-alone trial.'}, {'measure': 'Change in the Monthly Percentage of Patients Referred to Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities', 'timeFrame': '13-18 months post-baseline', 'description': 'CBTI referrals will be measured according to counts of CBTI consult requests in the medical record. For clinics that do not use medical record consult requests specific to CBTI, referrals will be measured using monthly counts provided by CBTI therapists. The denominator will consist of primary care patients who are not in hospice/palliative care. This will be a secondary outcome for the CBTI trial when analyzed as a stand-alone trial.'}, {'measure': 'Change in Percentage of Patients With First Line Sleep Medication Across Facilities', 'timeFrame': '13-18 months post-baseline', 'description': 'The proportion of patients with a new prescription for a sleep medication for insomnia who have not had CBTI of those who are actively followed by the clinic and not in hospice/palliative care. This is a CBTI sub-analysis of the overall MIDAS study primary outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implementation science', 'implementation strategy', 'anticoagulation', 'polypharmacy', 'insomnia', 'medication safety', 'academic detailing', 'quality improvement', 'pragmatic trial'], 'conditions': ['Polypharmacy', 'Insomnia', 'Anticoagulants']}, 'referencesModule': {'references': [{'pmid': '40529793', 'type': 'DERIVED', 'citation': 'Domlyn AM, Hooks G, Freitag M, Evans L, Stewart M, Damschroder L, Sussman JB. Core and modifiable components of academic detailing: demonstration of implementation strategy development, tailoring, and documentation process. Front Health Serv. 2025 Jun 3;5:1521504. doi: 10.3389/frhs.2025.1521504. eCollection 2025.'}, {'pmid': '35568903', 'type': 'DERIVED', 'citation': 'Damschroder LJ, Sussman JB, Pfeiffer PN, Kurlander JE, Freitag MB, Robinson CH, Spoutz P, Christopher MLD, Battar S, Dickerson K, Sedgwick C, Wallace-Lacey AG, Barnes GD, Linsky AM, Ulmer CS, Lowery JC. Maintaining Implementation through Dynamic Adaptations (MIDAS): protocol for a cluster-randomized trial of implementation strategies to optimize and sustain use of evidence-based practices in Veteran Health Administration (VHA) patients. Implement Sci Commun. 2022 May 14;3(1):53. doi: 10.1186/s43058-022-00297-z.'}]}, 'descriptionModule': {'briefSummary': 'Scientific advances are constantly leading to better treatments. However, it is quite challenging for healthcare systems, including VA, to ask very busy providers to change the way they practice. The MIDAS QUERI program will help providers improve the way they treat VA patients for three common conditions, using specific strategies to ensure the reliable delivery of these treatments. The first project will focus on reducing potentially inappropriate medication (PIM) use using the VIONE practice, developed in VA. The second project will focus on better use of drugs called direct oral anticoagulants (DOACs) for patients with a history of severe blood clots or an abnormal heart rhythm. The third project will focus on increasing the use of cognitive behavioral therapy for insomnia as the first-line treatment for insomnia instead of sleep medications. The investigators will test two implementation approaches to improve medication use within these topics.', 'detailedDescription': 'Background The adoption and sustainment of evidence-based practices (EBPs) is a challenge within many healthcare systems, especially in settings that have already strived but failed to achieve longer-term goals. The Veterans Affairs (VA) Maintaining Implementation through Dynamic Adaptations (MIDAS) Quality Enhancement Research Initiative (QUERI) program was funded as a series of trials to test multi-component implementation strategies to sustain optimal use of three EBPs: 1) a deprescribing approach intended to reduce potentially inappropriate polypharmacy; 2) appropriate dosing and drug selection of direct-acting anticoagulant medications (DOACs); and 3) use of cognitive behavioral therapy as first-line treatment for insomnia before pharmacologic treatment. We describe the design and methods for a harmonized series of cluster-randomized control trials comparing two implementation strategies.\n\nMethods For each trial, we will recruit 8-12 clinics (24-36 total). All will have access to a clinical dashboard that flags patients who may benefit from the target EBP at that clinic and provider. For each trial, clinics will be randomized to one of two implementation strategies to improve use of the EBPs: 1) individual-level academic detailing (AD); or 2) AD plus the team-based Learn. Engage. Act. Process. (LEAP) quality improvement (QI) learning program. The primary outcomes will be operationalized across the three trials as a patient-level dichotomous response (yes/no) indicating patients with potentially inappropriate medications (PIMs) among those who may benefit from the EBP. This outcome will be computed using month-by-month administrative data. Primary comparison between the two implementation strategies will be analyzed using generalized estimating equations (GEE) with clinic-level monthly percent of PIMs as the dependent variable. Primary comparative endpoint will be at 13-18 months post-baseline. Each trial will also be analyzed independently.\n\nDiscussion MIDAS QUERI trials will focus on fostering sustained use of EBPs that previously had targeted but incomplete implementation. Our implementation approaches are designed to engage frontline clinicians in a dynamic optimization process that integrates use of actionable clinical dashboard data and making incremental changes, designed to be feasible within busy clinical settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNote- the investigators are recruiting clinics - not individual patients.\n\n* Prior to implementation, the investigators will work with sites to ensure they have met the preconditions necessary to begin sustained optimization of the EBP:\n\n * a team leader or champion\n * an identified department with service leadership buy-in and control over the processes/practices impacted by the implementation\n * readily accessible data to measure process and impact of the implementation and use of the EBP\n * availability of required resources\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT05065502', 'acronym': 'MIDAS cRCT', 'briefTitle': 'MIDAS Cluster Randomized Controlled Trial of Implementation Strategies to Optimize Use of Medications in VA Clinical Settings', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Maintaining Implementation Through Dynamic Adaptations (MIDAS) (QUE 20-025)', 'orgStudyIdInfo': {'id': 'QUX 21-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Academic Detailing (AD) Only', 'description': 'One-on-one educational outreach to employees and providers.', 'interventionNames': ['Behavioral: Academic Detailing (AD)']}, {'type': 'EXPERIMENTAL', 'label': 'AD + LEAP Combined', 'description': 'This arm combines use of AD plus the Learn. Engage. Act. Process (LEAP) program. LEAP is a 6-month quality improvement coaching program plus a 6-month monthly follow-up.', 'interventionNames': ['Behavioral: Academic Detailing (AD)', 'Behavioral: LEAP']}], 'interventions': [{'name': 'Academic Detailing (AD)', 'type': 'BEHAVIORAL', 'description': 'The National Resource Center for Academic Detailing (NaRCAD) describes AD as "an innovative, one-on-one outreach education technique that helps clinicians provide evidence-based care to their patients. Using an accurate, up-to-date synthesis of the best clinical evidence in an engaging format, academic detailers ignite clinician behavior change, ultimately improving patient health. A successful AD visit is highly interactive, always a dialogue, and assesses a clinician\'s individual needs, beliefs, attitudes, issues, and concerns in order to promote better.\\[practice\\]."', 'armGroupLabels': ['AD + LEAP Combined', 'Academic Detailing (AD) Only']}, {'name': 'LEAP', 'type': 'BEHAVIORAL', 'description': "Learn. Engage. Act. Process (LEAP) program is a structured 6-month core curriculum plus 6 monthly collaborative sessions. The LEAP quality improvement program engages frontline teams in sustained incremental improvements of EBPs over a six-month period, allowing space for busy clinicians to learn and immediately apply fundamental QI skills. LEAP encompasses: 1) a structured, accessible curriculum based on the Institute for Healthcare Improvement's (IHI) Model for Improvement and Plan-Do-Study-Act cycles of change; 2) team-based, hands-on learning, and 3) coaching support and a QI network to enhance learning and accountability.", 'armGroupLabels': ['AD + LEAP Combined']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105-2303', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor Healthcare System, Ann Arbor, MI', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Jeremy B. Sussman, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}, {'name': 'Ariel Domlyn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}, {'name': 'Jacob E Kurlander, MD MS MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}, {'name': 'Paul N Pfeiffer, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'For 36 months after article is published.', 'ipdSharing': 'YES', 'description': 'Site-level data that underlie results reported, after de-identification will be available.', 'accessCriteria': 'Upon request by researchers who provide a methodologically sound proposal. Further details will be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}