Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2026-01-09 @ 11:01 PM
Study NCT ID:
NCT01875861
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2013-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Monitoring and Management for Metabolic Side Effects of Antipsychotics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Richard.Owen2@va.gov', 'phone': '(501) 257-1710', 'title': 'Dr. Richard Owen', 'organization': 'Central Arkansas Veterans Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "This study was planned in conjunction with a national effort to improve metabolic monitoring and management for Veterans prescribed antipsychotic medications. However, this study's implementation activities started after the national effort ended.."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Evidence-Based Quality Improvement plus external facilitation to promote uptake of QI tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, QI tools, and improvement strategies relevant to metabolic monitoring and management.\n\nEvidence-Based Quality Improvement Plus Facilitation: The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase.', 'otherNumAtRisk': 11335, 'otherNumAffected': 0, 'seriousNumAtRisk': 11335, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comparison', 'description': '"Usual care" with access to information about QI tools and improvement strategies, but no Evidence-Based Quality Improvement or Facilitation components.', 'otherNumAtRisk': 8766, 'otherNumAffected': 0, 'seriousNumAtRisk': 8766, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9214', 'groupId': 'OG000'}, {'value': '7213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Evidence-Based Quality Improvement plus external facilitation to promote uptake of QI tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, QI tools, and improvement strategies relevant to metabolic monitoring and management.\n\nEvidence-Based Quality Improvement Plus Facilitation: The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase.'}, {'id': 'OG001', 'title': 'Comparison', 'description': '"Usual care," in the context of the MIAMI Project.'}], 'classes': [{'title': 'Pre-Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3200', 'groupId': 'OG000'}, {'value': '2516', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1811', 'groupId': 'OG000'}, {'value': '1410', 'groupId': 'OG001'}]}]}, {'title': 'Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3118', 'groupId': 'OG000'}, {'value': '2379', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1598', 'groupId': 'OG000'}, {'value': '1109', 'groupId': 'OG001'}]}]}, {'title': 'Sustainability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2896', 'groupId': 'OG000'}, {'value': '2318', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1384', 'groupId': 'OG000'}, {'value': '1043', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.38', 'groupDescription': 'Because of data discontinuity, assumptions for time series analysis did not hold. Repeated measures regression models were developed to compare overall weight monitoring rates at baseline across the implementation phases.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases', 'description': 'For each monthly observation: The proportion of patients at each site due for weight monitoring at baseline who have weight recorded in the electronic health record.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who met inclusion criteria for this measure. Note that total for Outcome 1 is less than overall total N because patients were included for each measure independently if they met criteria any time in the 6-month implementation phases. Slightly more patients met criteria for the "follow-up monitoring" measures than "baseline monitoring."'}, {'type': 'SECONDARY', 'title': 'Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9302', 'groupId': 'OG000'}, {'value': '7174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Evidence-Based Quality Improvement plus external facilitation to promote uptake of QI tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, QI tools, and improvement strategies relevant to metabolic monitoring and management.\n\nEvidence-Based Quality Improvement Plus Facilitation: The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase.'}, {'id': 'OG001', 'title': 'Comparison', 'description': '"Usual care" with access to information about QI tools and improvement strategies, but no Evidence-Based Quality Improvement or Facilitation components.'}], 'classes': [{'title': 'Pre-Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3264', 'groupId': 'OG000'}, {'value': '2532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1696', 'groupId': 'OG000'}, {'value': '1337', 'groupId': 'OG001'}]}]}, {'title': 'Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3141', 'groupId': 'OG000'}, {'value': '2315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1477', 'groupId': 'OG000'}, {'value': '1005', 'groupId': 'OG001'}]}]}, {'title': 'Sustainability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2897', 'groupId': 'OG000'}, {'value': '2327', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1265', 'groupId': 'OG000'}, {'value': '992', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.39', 'groupDescription': 'See comments about time series analysis for primary outcome measure. Repeated measures regression analysis of the likelihood of monitoring for each time period was conducted.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases', 'description': 'For each monthly observation: The proportion of patients at each site due for weight monitoring at follow-up who have weight recorded in the electronic health record.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients meeting inclusion/exclusion criteria'}, {'type': 'SECONDARY', 'title': 'Change in Site-level Rates of Management for Obesity or Weight Gain Within 30 Days After a Recording of 5% Gain in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Evidence-Based Quality Improvement plus external facilitation to promote uptake of QI tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, QI tools, and improvement strategies relevant to metabolic monitoring and management.\n\nEvidence-Based Quality Improvement Plus Facilitation: The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase.'}, {'id': 'OG001', 'title': 'Comparison', 'description': '"Usual care" with access to information about QI tools and improvement strategies, but no Evidence-Based Quality Improvement or Facilitation components.'}], 'classes': [{'title': 'Pre-Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Sustainability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Change in weight management rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases', 'description': 'For each monthly observation: The proportion of patients at each site with weight gain that have guideline-recommended weight management (e.g., counseling about diet or exercise, referral to weight management program) initiated within 30 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients meeting inclusion/exclusion criteria'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Evidence-Based Quality Improvement plus external facilitation to promote uptake of quality improvement tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, tools, and improvement strategies relevant to metabolic monitoring and management.\n\nEvidence-Based Quality Improvement Plus Facilitation: The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase.'}, {'id': 'FG001', 'title': 'Comparison', 'description': '"Usual care" with access to information about QI tools and improvement strategies, but no Evidence-Based Quality Improvement or Facilitation components.'}], 'periods': [{'title': 'Pre-implementation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '4779'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '3714'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '4779'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '3714'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Implementation', 'milestones': [{'type': 'STARTED', 'comment': 'The number of patients within each period is independent of the number in other periods.', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '4546'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '3444'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '4546'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '3444'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Sustainability', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '4306'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '3444'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '4306'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '3444'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Sites', 'recruitmentDetails': 'Twelve sites were recruited, matched according to level of organizational readiness-to-change, and randomized to intervention/control group within each of the 6 site-pairs. Patients with a new antipsychotic medication start were identified using VA data in 6-month pre-implementation, implementation, and sustainability periods.', 'preAssignmentDetails': 'Participants were continuously entered into the study when starting a new antipsychotic treatment and were assessed up to 120 days later, thus the number of participants within each period is independent of one another and for some participants where the 120 days spanned two periods they are counted in more than one period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11335', 'groupId': 'BG000'}, {'value': '8766', 'groupId': 'BG001'}, {'value': '20101', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Evidence-Based Quality Improvement plus external facilitation to promote uptake of QI tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, QI tools, and improvement strategies relevant to metabolic monitoring and management.\n\nEvidence-Based Quality Improvement Plus Facilitation: The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase.'}, {'id': 'BG001', 'title': 'Comparison', 'description': '"Usual care" with access to information about QI tools and improvement strategies, but no Evidence-Based Quality Improvement or Facilitation components.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Overall Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11335', 'groupId': 'BG000'}, {'value': '8766', 'groupId': 'BG001'}, {'value': '20101', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.19', 'spread': '15.99', 'groupId': 'BG000'}, {'value': '53.67', 'spread': '16.62', 'groupId': 'BG001'}, {'value': '53.93', 'spread': '16.28', 'groupId': 'BG002'}]}]}, {'title': 'Pre-Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4779', 'groupId': 'BG000'}, {'value': '3714', 'groupId': 'BG001'}, {'value': '8493', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.51', 'spread': '15.67', 'groupId': 'BG000'}, {'value': '54.06', 'spread': '16.18', 'groupId': 'BG001'}, {'value': '54.31', 'spread': '15.9', 'groupId': 'BG002'}]}]}, {'title': 'Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4546', 'groupId': 'BG000'}, {'value': '3444', 'groupId': 'BG001'}, {'value': '7990', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.75', 'spread': '16.02', 'groupId': 'BG000'}, {'value': '52.82', 'spread': '16.64', 'groupId': 'BG001'}, {'value': '53.35', 'spread': '16.29', 'groupId': 'BG002'}]}]}, {'title': 'Sustainability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4306', 'groupId': 'BG000'}, {'value': '3444', 'groupId': 'BG001'}, {'value': '7750', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.45', 'spread': '16.08', 'groupId': 'BG000'}, {'value': '53.06', 'spread': '16.54', 'groupId': 'BG001'}, {'value': '53.28', 'spread': '16.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Overall Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11335', 'groupId': 'BG000'}, {'value': '8766', 'groupId': 'BG001'}, {'value': '20101', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1337', 'groupId': 'BG000'}, {'value': '1027', 'groupId': 'BG001'}, {'value': '2364', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9998', 'groupId': 'BG000'}, {'value': '7739', 'groupId': 'BG001'}, {'value': '17737', 'groupId': 'BG002'}]}]}, {'title': 'Pre-Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4779', 'groupId': 'BG000'}, {'value': '3714', 'groupId': 'BG001'}, {'value': '8493', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '544', 'groupId': 'BG000'}, {'value': '421', 'groupId': 'BG001'}, {'value': '965', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4235', 'groupId': 'BG000'}, {'value': '3293', 'groupId': 'BG001'}, {'value': '7528', 'groupId': 'BG002'}]}]}, {'title': 'Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4546', 'groupId': 'BG000'}, {'value': '3444', 'groupId': 'BG001'}, {'value': '7990', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '562', 'groupId': 'BG000'}, {'value': '433', 'groupId': 'BG001'}, {'value': '995', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3984', 'groupId': 'BG000'}, {'value': '3011', 'groupId': 'BG001'}, {'value': '6995', 'groupId': 'BG002'}]}]}, {'title': 'Sustainability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4306', 'groupId': 'BG000'}, {'value': '3444', 'groupId': 'BG001'}, {'value': '7750', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '524', 'groupId': 'BG000'}, {'value': '441', 'groupId': 'BG001'}, {'value': '965', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3782', 'groupId': 'BG000'}, {'value': '3003', 'groupId': 'BG001'}, {'value': '6785', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Overall Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11335', 'groupId': 'BG000'}, {'value': '8766', 'groupId': 'BG001'}, {'value': '20101', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '497', 'groupId': 'BG000'}, {'value': '423', 'groupId': 'BG001'}, {'value': '920', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10459', 'groupId': 'BG000'}, {'value': '7865', 'groupId': 'BG001'}, {'value': '18324', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '379', 'groupId': 'BG000'}, {'value': '478', 'groupId': 'BG001'}, {'value': '857', 'groupId': 'BG002'}]}]}, {'title': 'Pre-Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4779', 'groupId': 'BG000'}, {'value': '3714', 'groupId': 'BG001'}, {'value': '8493', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4394', 'groupId': 'BG000'}, {'value': '3341', 'groupId': 'BG001'}, {'value': '7735', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '374', 'groupId': 'BG002'}]}]}, {'title': 'Implementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4546', 'groupId': 'BG000'}, {'value': '3444', 'groupId': 'BG001'}, {'value': '7990', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4197', 'groupId': 'BG000'}, {'value': '3101', 'groupId': 'BG001'}, {'value': '7298', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}]}, {'title': 'Sustainability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4306', 'groupId': 'BG000'}, {'value': '3444', 'groupId': 'BG001'}, {'value': '7750', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3986', 'groupId': 'BG000'}, {'value': '3107', 'groupId': 'BG001'}, {'value': '7093', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.'}, {'title': 'Race/Ethnicity, Customized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11335', 'groupId': 'BG000'}, {'value': '8766', 'groupId': 'BG001'}, {'value': '20101', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '7450', 'groupId': 'BG000'}, {'value': '5828', 'groupId': 'BG001'}, {'value': '13278', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2791', 'groupId': 'BG000'}, {'value': '2239', 'groupId': 'BG001'}, {'value': '5030', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '398', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '604', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '696', 'groupId': 'BG000'}, {'value': '493', 'groupId': 'BG001'}, {'value': '1189', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11335', 'groupId': 'BG000'}, {'value': '8766', 'groupId': 'BG001'}, {'value': '20101', 'groupId': 'BG002'}]}, {'units': 'Sites', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11335', 'groupId': 'BG000'}, {'value': '8766', 'groupId': 'BG001'}, {'value': '20101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Sites', 'populationDescription': 'For each outcome measure, patients are selected when a new antipsychotic medication is prescribed. Some patients appear in more than one period (pre-implementation, implementation, sustainability); baseline characteristics are presented for the total sample (N=20,101) with rows for each period.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2013-06-05', 'resultsFirstSubmitDate': '2017-07-14', 'studyFirstSubmitQcDate': '2013-06-07', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-07', 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription)', 'timeFrame': 'Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases', 'description': 'For each monthly observation: The proportion of patients at each site due for weight monitoring at baseline who have weight recorded in the electronic health record.'}], 'secondaryOutcomes': [{'measure': 'Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription)', 'timeFrame': 'Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases', 'description': 'For each monthly observation: The proportion of patients at each site due for weight monitoring at follow-up who have weight recorded in the electronic health record.'}, {'measure': 'Change in Site-level Rates of Management for Obesity or Weight Gain Within 30 Days After a Recording of 5% Gain in Body Weight', 'timeFrame': 'Change in weight management rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases', 'description': 'For each monthly observation: The proportion of patients at each site with weight gain that have guideline-recommended weight management (e.g., counseling about diet or exercise, referral to weight management program) initiated within 30 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antipsychotic Agents', 'Metabolic Syndrome', 'Quality Improvement'], 'conditions': ['Mental Health', 'Psychotic Disorders']}, 'referencesModule': {'references': [{'pmid': '21777479', 'type': 'BACKGROUND', 'citation': 'Helfrich CD, Blevins D, Smith JL, Kelly PA, Hogan TP, Hagedorn H, Dubbert PM, Sales AE. Predicting implementation from organizational readiness for change: a study protocol. Implement Sci. 2011 Jul 22;6:76. doi: 10.1186/1748-5908-6-76.'}, {'pmid': '24103648', 'type': 'BACKGROUND', 'citation': 'Owen RR, Drummond KL, Viverito KM, Marchant K, Pope SK, Smith JL, Landes RD. Monitoring and managing metabolic effects of antipsychotics: a cluster randomized trial of an intervention combining evidence-based quality improvement and external facilitation. Implement Sci. 2013 Oct 8;8:120. doi: 10.1186/1748-5908-8-120.'}, {'pmid': '24585327', 'type': 'BACKGROUND', 'citation': 'Fortney JC, Owen RR. Increasing treatment engagement for persons with serious mental illness using personal health records. Am J Psychiatry. 2014 Mar;171(3):259-61. doi: 10.1176/appi.ajp.2013.13121701. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test an approach for implementing guideline recommendations for assessing and managing metabolic side effects (including weight gain, diabetes, elevated lipids) in patients prescribed antipsychotic medications.', 'detailedDescription': 'Treatment of psychotic disorders consists primarily of antipsychotic medications, which are associated with metabolic side effects such as overweight/obesity, diabetes, and dyslipidemia. Expert consensus and evidence-based recommendations have been developed for assessment and management of these conditions; however, research studies show deficits and delays in metabolic monitoring for patients prescribed antipsychotics. This purpose of this study is to test a quality improvement intervention to enhance implementation of recommendations for assessing and managing metabolic side effects in patients prescribed antipsychotic medications.\n\nStudy Objectives are:\n\n* Objective 1: To test the effect of an Evidence-Based Quality Improvement/Facilitation (EBQI/F) intervention as an augmentation to a national implementation initiative on rates of monitoring for metabolic side effects of antipsychotics in sites likely to encounter greater challenges to implementation.\n* Objective 2: To test the effect of the EBQI/F intervention as an augmentation to the national implementation initiative on management of metabolic side effects of antipsychotics in sites likely to encounter greater challenges to implementation.\n* Objective 3: To assess the direct costs of the EBQI/F intervention, and explore potential variations in costs of the EBQI/F intervention in sites with lower versus higher organizational challenges.\n\nMethods This study employs a cluster randomized design with eligible study sites including VA Medical Centers with 300 patients receiving a new antipsychotic prescription in the first six months of Fiscal Year 2008. Twelve sites have been recruited and matched according to level of organizational readiness-to-change. Randomization to intervention or control group was conducted within each of the six site-pairs. Study participants include VA employees involved in the monitoring and management of patients treated with antipsychotics at participating sites. The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase. The effectiveness of the EBQI/F intervention combined with the ongoing national quality improvement initiative at six sites (intervention sites) will be compared to six matched comparison sites exposed to the national quality improvement initiative alone (control sites).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Providers involved in antipsychotic management or management of metabolic side effects and related conditions\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT01875861', 'acronym': 'AMMP', 'briefTitle': 'Monitoring and Management for Metabolic Side Effects of Antipsychotics', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Monitoring and Management for Metabolic Effects of Antipsychotics', 'orgStudyIdInfo': {'id': 'SDP 08-375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Evidence-Based Quality Improvement plus external facilitation to promote uptake of quality improvement tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, tools, and improvement strategies relevant to metabolic monitoring and management.', 'interventionNames': ['Other: Evidence-Based Quality Improvement Plus Facilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison', 'description': '"Usual care," in the context of the MIAMI Project.'}], 'interventions': [{'name': 'Evidence-Based Quality Improvement Plus Facilitation', 'type': 'OTHER', 'otherNames': ['EBQI/F'], 'description': 'The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72114-1706', 'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}], 'overallOfficials': [{'name': 'Richard R. Owen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}