Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04363320
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2020-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fostering MAT Use in Justice Populations
Sponsor:
Organization:
Raw JSON
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{'units': 'sites', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG001', 'title': 'Low-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG002', 'title': 'High-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& 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'OG003'}]}]}, {'title': 'Buprenorphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4572', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '569', 'groupId': 'OG002'}, {'value': '1908', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.79', 'spread': '28.5', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '4.05', 'groupId': 'OG001'}, {'value': '5.01', 'spread': '2.98', 'groupId': 'OG002'}, {'value': '17.43', 'spread': '25.56', 'groupId': 'OG003'}]}]}, {'title': 'Naltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4572', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '569', 'groupId': 'OG002'}, {'value': '1908', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '0.86', 'groupId': 'OG002'}, {'value': '1.37', 'spread': '2.05', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.538', 'pValueComment': 'a prior threshold 0.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.169', 'estimateComment': 'Slope is per month', 'groupDescription': 'Change in new patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0008', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 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Due to lack of tracking systems in the jail, some sites were only able to provide one of the two monthly counts.'}, {'type': 'PRIMARY', 'title': 'Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6345', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '542', 'groupId': 'OG002'}, {'value': '3022', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG001', 'title': 'Low-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG002', 'title': 'High-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team'}, {'id': 'OG003', 'title': 'Low-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team'}], 'classes': [{'title': 'Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6345', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '542', 'groupId': 'OG002'}, {'value': '3022', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.29', 'spread': '75.24', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '4.67', 'spread': '6.6', 'groupId': 'OG002'}, {'value': '2.41', 'spread': '6.31', 'groupId': 'OG003'}]}]}, {'title': 'Buprenorphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6345', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '542', 'groupId': 'OG002'}, {'value': '3022', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.37', 'spread': '35.77', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '7.89', 'spread': '3.18', 'groupId': 'OG002'}, {'value': '32.32', 'spread': '60.72', 'groupId': 'OG003'}]}]}, {'title': 'Naltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6345', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '542', 'groupId': 'OG002'}, {'value': '3022', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '1.59', 'groupId': 'OG001'}, {'value': '0.71', 'spread': '0.79', 'groupId': 'OG002'}, {'value': '0.79', 'spread': '1.01', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.485', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.153', 'pValueComment': 'a priori 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'a priori threshold: 0.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.154', 'estimateComment': 'Slope is per month.', 'groupDescription': 'Change in new patient counts (Methadone) for Sustainability Phase (from 13 to 24 months)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.241', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.02', 'pValueComment': 'a priori threshold: 0.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.017', 'estimateComment': 'Slope is per month.', 'groupDescription': 'Change in new patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '13 months, 24 months', 'description': "The intervention reach will be measured using data gathered through organization monthly tracking 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Due to lack of tracking systems in the jail, some sites were only able to provide one of the two monthly counts.'}, {'type': 'PRIMARY', 'title': 'Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19120', 'groupId': 'OG000'}, {'value': '8588', 'groupId': 'OG001'}, {'value': '9025', 'groupId': 'OG002'}, {'value': '6263', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG001', 'title': 'Low-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG002', 'title': 'High-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team'}, {'id': 'OG003', 'title': 'Low-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team'}], 'classes': [{'title': 'Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19120', 'groupId': 'OG000'}, {'value': '8588', 'groupId': 'OG001'}, {'value': '9025', 'groupId': 'OG002'}, {'value': '6263', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.73', 'spread': '216.36', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '56.58', 'spread': '158.40', 'groupId': 'OG002'}, {'value': '0.94', 'spread': '1.80', 'groupId': 'OG003'}]}]}, {'title': 'Buprenorphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19120', 'groupId': 'OG000'}, {'value': '8588', 'groupId': 'OG001'}, {'value': '9025', 'groupId': 'OG002'}, {'value': '6263', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '104.07', 'spread': '145.32', 'groupId': 'OG000'}, {'value': '117.62', 'spread': '190.42', 'groupId': 'OG001'}, {'value': '36.50', 'spread': '45.29', 'groupId': 'OG002'}, {'value': '60.57', 'spread': '105.31', 'groupId': 'OG003'}]}]}, {'title': 'Naltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19120', 'groupId': 'OG000'}, {'value': '8588', 'groupId': 'OG001'}, {'value': '9025', 'groupId': 'OG002'}, {'value': '6263', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '2.60', 'spread': '5.29', 'groupId': 'OG001'}, {'value': '5.81', 'spread': '15.04', 'groupId': 'OG002'}, {'value': '3.21', 'spread': '6.16', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.00002', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.912', 'pValueComment': 'a priori threshold: 0.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.438', 'estimateComment': 'Slope is per month.', 'groupDescription': 'Change in census patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.00004', 'groupIds': ['OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.855', 'pValueComment': 'a priori threshold: 0.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.206', 'estimateComment': 'Slope is per month.', 'groupDescription': 'Change in census patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.118', 'groupIds': ['OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.322', 'pValueComment': 'a priori threshold: 0.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.206', 'estimateComment': 'Slope is per month.', 'groupDescription': 'Change in census patient counts (Methadone) for Intervention Phase (from baseline to 12 months)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.020', 'groupIds': ['OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.073', 'pValueComment': 'a priori threshold: 0.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.031', 'estimateComment': 'Slope is per month.', 'groupDescription': 'Change in census patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months', 'description': "The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 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Due to lack of tracking systems in the jail, some sites were only able to provide one of the two monthly counts.'}, {'type': 'PRIMARY', 'title': 'Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24145', 'groupId': 'OG000'}, {'value': '5799', 'groupId': 'OG001'}, {'value': '9489', 'groupId': 'OG002'}, {'value': '8041', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG001', 'title': 'Low-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG002', 'title': 'High-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team'}, {'id': 'OG003', 'title': 'Low-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team'}], 'classes': [{'title': 'Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24145', 'groupId': 'OG000'}, {'value': '5799', 'groupId': 'OG001'}, {'value': '9489', 'groupId': 'OG002'}, {'value': '8041', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '110.19', 'spread': '219.28', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '77.22', 'spread': '183.37', 'groupId': 'OG002'}, {'value': '1.96', 'spread': '3.71', 'groupId': 'OG003'}]}]}, {'title': 'Buprenorphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24145', 'groupId': 'OG000'}, {'value': '5799', 'groupId': 'OG001'}, {'value': '9489', 'groupId': 'OG002'}, {'value': '8041', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '127.32', 'spread': '177.17', 'groupId': 'OG000'}, {'value': '154.78', 'spread': '227.42', 'groupId': 'OG001'}, {'value': '43.71', 'spread': '43.31', 'groupId': 'OG002'}, {'value': '78.24', 'spread': '136.17', 'groupId': 'OG003'}]}]}, {'title': 'Naltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24145', 'groupId': 'OG000'}, {'value': '5799', 'groupId': 'OG001'}, {'value': '9489', 'groupId': 'OG002'}, {'value': '8041', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '1.56', 'groupId': 'OG001'}, {'value': '10.86', 'spread': '18.72', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '6.44', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.045', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.617', 'pValueComment': 'a priori threshold: 0.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.307', 'estimateComment': 'Slope is per month.', 'groupDescription': 'Change in census patient counts (Combined MOUD) for Sustainability Phase (from 13 to 24 months)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.000002', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.103', 'pValueComment': 'a priori threshold: 0.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.229', 'estimateComment': 'Slope is per month.', 'groupDescription': 'Change in census patient counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.076', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.387', 'pValueComment': 'a priori threshold: 0.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.218', 'estimateComment': 'Slope is per month', 'groupDescription': 'Change in census patient counts (Methadone) for Sustainability Phase (13 to 24 months)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.086', 'pValueComment': 'a priori threshold: 0.05', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.036', 'estimateComment': 'Slope is per month.', 'groupDescription': 'Change in census patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '13 months to 24 months', 'description': "The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.", 'unitOfMeasure': 'Justice Involved Persons per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sites', 'denomUnitsSelected': 'sites', 'populationDescription': 'The Overall Number of Participants Analyzed reported are justice involved individuals staff (who were not consented and enrolled). Staff (consented participants) collected counts of justice involved individuals with various MOUD from their sites. Not all sites provided all three forms of medication at all times. Due to lack of tracking systems in the jail, some sites were only able to provide one of the two monthly counts.'}, {'type': 'PRIMARY', 'title': 'Change in Number of Prescribers Using MOUD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG001', 'title': 'Low-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG002', 'title': 'High-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team'}, {'id': 'OG003', 'title': 'Low-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team'}], 'classes': [{'title': 'baseline'}, {'title': '12 months'}, {'title': '24 months'}], 'timeFrame': 'baseline, 12 months, 24 months', 'description': 'The adoption of each intervention will be in part measured by tracking the number of prescribers using MOUD at each time point.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for this outcome. This outcome was determined to not be a key variable at study start and should have been removed from the protocol. It was apparent from listening to sites that increasing the number of prescribers was not a goal as they were already encountering high turnover rates and staffing.'}, {'type': 'SECONDARY', 'title': 'MOUD Sustainability Measured Using the Program Sustainability Assessment Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG001', 'title': 'Low-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG002', 'title': 'High-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team'}, {'id': 'OG003', 'title': 'Low-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '44.79487', 'spread': '17.88808', 'groupId': 'OG000'}, {'value': '43.75385', 'spread': '15.68342', 'groupId': 'OG001'}, {'value': '43.16667', 'spread': '14.61386', 'groupId': 'OG002'}, {'value': '43.96226', 'spread': '12.7701', 'groupId': 'OG003'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50.71429', 'spread': '8.827025', 'groupId': 'OG000'}, {'value': '50.78571', 'spread': '8.252304', 'groupId': 'OG001'}, {'value': '45.95556', 'spread': '10.73642', 'groupId': 'OG002'}, {'value': '51.61905', 'spread': '10.70736', 'groupId': 'OG003'}]}]}, {'title': '24 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}, {'units': 'sites', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '51.51429', 'spread': '13.18504', 'groupId': 'OG000'}, {'value': '49.30435', 'spread': '8.704413', 'groupId': 'OG001'}, {'value': '48.37143', 'spread': '11.95847', 'groupId': 'OG002'}, {'value': '53.70833', 'spread': '14.0077', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 12 months, 24 months', 'description': 'The maintenance of the intervention (MOUD Sustainability) will be measured using the Program Sustainability Assessment Tool included in the Staff Survey at three points during the study (baseline, 12-months \\& 24-months) to determine if likelihood of sustainability increases as study progresses. This tool has a total possible range of scores from 0-63 with higher scores indicating increased sustainability of the intervention.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sites', 'denomUnitsSelected': 'sites', 'populationDescription': 'Number of participants and sites included in data analysis changed through study conduct.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'NIATx Fidelity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG001', 'title': 'Low-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'OG002', 'title': 'High-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team'}, {'id': 'OG003', 'title': 'Low-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team'}], 'classes': [{'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.2381', 'spread': '6.449842', 'groupId': 'OG000'}, {'value': '25.39286', 'spread': '4.474945', 'groupId': 'OG001'}, {'value': '24.11111', 'spread': '6.544332', 'groupId': 'OG002'}, {'value': '24.71429', 'spread': '5.917287', 'groupId': 'OG003'}]}]}, {'title': '24 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.57143', 'spread': '5.494841', 'groupId': 'OG000'}, {'value': '23.13043', 'spread': '4.07101', 'groupId': 'OG001'}, {'value': '24.62857', 'spread': '7.272372', 'groupId': 'OG002'}, {'value': '27.16667', 'spread': '6.112472', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months, 24 months', 'description': 'Assess fidelity to the NIATx implementation strategies at two points during the study using a 10-item measure with scores ranging from 0-40 with higher scores indicating stronger fidelity of the intervention.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants included in data analysis changed through study conduct.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls\n\nNIATx Coaching: NIATx framework provides each participating site with a NIATx Coach who is an expert in MOUD implementation and organizational change and will help the organization adopt, implement, and increase the use of MOUD. Coaches help the sites think through key issues, offer process improvement training, and suggest changes.\n\nECHO: The ECHO model connects MOUD prescribers and experts with primary care providers and medical teams to promote high-quality MOUD practices. ECHO is provided monthly through videoconferences. Experienced MOUD prescribers address topics such as counseling strategies, urine test interpretation, and transitioning from buprenorphine, naltrexone and methadone.'}, {'id': 'FG001', 'title': 'Low-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls\n\nNIATx Coaching: NIATx framework provides each participating site with a NIATx Coach who is an expert in MOUD implementation and organizational change and will help the organization adopt, implement, and increase the use of MOUD. Coaches help the sites think through key issues, offer process improvement training, and suggest changes.\n\nECHO: The ECHO model connects MOUD prescribers and experts with primary care providers and medical teams to promote high-quality MOUD practices. ECHO is provided monthly through videoconferences. Experienced MOUD prescribers address topics such as counseling strategies, urine test interpretation, and transitioning from buprenorphine, naltrexone and methadone.'}, {'id': 'FG002', 'title': 'High-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team\n\nNIATx Coaching: NIATx framework provides each participating site with a NIATx Coach who is an expert in MOUD implementation and organizational change and will help the organization adopt, implement, and increase the use of MOUD. Coaches help the sites think through key issues, offer process improvement training, and suggest changes.'}, {'id': 'FG003', 'title': 'Low-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team\n\nNIATx Coaching: NIATx framework provides each participating site with a NIATx Coach who is an expert in MOUD implementation and organizational change and will help the organization adopt, implement, and increase the use of MOUD. Coaches help the sites think through key issues, offer process improvement training, and suggest changes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Staff were consented at sites.', 'achievements': [{'groupId': 'FG000', 'numUnits': '14', 'numSubjects': '78'}, {'groupId': 'FG001', 'numUnits': '11', 'numSubjects': '65'}, {'groupId': 'FG002', 'numUnits': '10', 'numSubjects': '60'}, {'groupId': 'FG003', 'numUnits': '13', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'comment': 'Reasons for sites dropping included change in leadership (new leadership not interested in participating), lack of referrals from the jail, or doors closed due to lack loss of funding.', 'achievements': [{'groupId': 'FG000', 'numUnits': '9', 'numSubjects': '35'}, {'groupId': 'FG001', 'numUnits': '10', 'numSubjects': '23'}, {'groupId': 'FG002', 'numUnits': '9', 'numSubjects': '35'}, {'groupId': 'FG003', 'numUnits': '10', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '43'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '42'}, {'groupId': 'FG002', 'numUnits': '1', 'numSubjects': '25'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Sites', 'recruitmentDetails': '48 sites were recruited, 38 (25 jails \\& 13 Community based treatment provider (CBTP) sites completed the study (sites per intervention listed in the participant flow). Consenting Participants are staff at the sites who provided data, including counts of people prescribed medications for opioid use disorder (MOUD) at their sites (see outcome measures for this data).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '256', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'High-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'BG001', 'title': 'Low-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls'}, {'id': 'BG002', 'title': 'High-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team'}, {'id': 'BG003', 'title': 'Low-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '256', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '68'}, {'value': '42', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '74'}, {'value': '46', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '74'}, {'value': '46', 'groupId': 'BG003', 'lowerLimit': '24', 'upperLimit': '76'}, {'value': '46', 'groupId': 'BG004', 'lowerLimit': '22', 'upperLimit': '76'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex/Gender, Customized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '256', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '146', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '256', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '224', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '256', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '169', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '256', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '256', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Geographic Location of Sites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '256', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'classes': [{'categories': [{'title': 'Rural', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Suburban', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Urban', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Sites Starting Study', 'denomUnitsSelected': 'Sites Starting Study', 'populationDescription': 'Data applies to site characteristics.'}, {'title': 'Gender Served', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '256', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'classes': [{'categories': [{'title': 'Male only', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Female only', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Both', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Sites Starting Study', 'denomUnitsSelected': 'Sites Starting Study', 'populationDescription': 'Data applies to site characteristics.'}, {'title': 'Average Daily Population (Jails only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '180', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}], 'classes': [{'categories': [{'title': 'less than 100', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': '101-250', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': '251-500', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'greater than 500', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Sites Starting Study', 'denomUnitsSelected': 'Sites Starting Study', 'populationDescription': 'Data applies to site characteristics for Jails only.'}, {'title': 'Average Monthly OUD Intakes (CBTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'classes': [{'categories': [{'title': 'less than 50', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': '51-200', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': '201-500', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'greater than 500', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'unknown', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Sites Starting Study', 'denomUnitsSelected': 'Sites Starting Study', 'populationDescription': 'Data applies to site characteristics for CBTP only.'}, {'title': 'Type of Healthcare Model at Jails', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '180', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}], 'classes': [{'categories': [{'title': 'Direct', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Contracted', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Hybrid', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Sites Starting Study', 'denomUnitsSelected': 'Sites Starting Study', 'populationDescription': 'Data applies to site characteristics at Jails only.'}, {'title': 'CBTP Arrangements with Jails', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'classes': [{'title': 'Joint Staffings', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Shared Written Agreements', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'Electronic Health Record Access', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Referral Processes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Sites Starting Study', 'denomUnitsSelected': 'Sites Starting Study', 'populationDescription': 'Data applies to site characteristics CBTP only.'}, {'title': 'MOUD Offered at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '256', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'classes': [{'title': 'Buprenorphine/Naloxone', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}, {'title': 'Naltrexone (injectable)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}, {'title': 'Naltrexone (oral)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}, {'title': 'Methadone', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}, {'title': 'No MOUD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Sites Starting Study', 'denomUnitsSelected': 'Sites Starting Study', 'populationDescription': 'Data applies to site characteristics.'}, {'title': 'Type of Study Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '256', 'groupId': 'BG004'}]}, {'units': 'Sites Starting Study', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'classes': [{'categories': [{'title': 'Jails', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'title': 'Community Based Treatment Providers', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Sites Starting Study', 'denomUnitsSelected': 'Sites Starting Study'}], 'typeUnitsAnalyzed': 'Sites Starting Study', 'populationDescription': 'The overall number analyzed includes the count of staff participants consented. The overall number of units analyzed is the number of sites that started the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-02', 'size': 1190636, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-04T16:04', 'hasProtocol': True}, {'date': '2020-04-06', 'size': 255508, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-04T16:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'The proposed study will implement a cluster randomized block design where staff are nested within sites. The community-based provider sites and jails will be grouped into homogeneous blocks and then randomly assigned into 2x2 factorial design for each block. The forty-eights sites will be assigned to one of four study arms using a matching strategy within the blocks that groups four jail-clinic combination together prior to randomization. Each jail and cognitive behavioral (CB) treatment provider (or clinic) in these combinations will be treated as a site.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2020-04-23', 'resultsFirstSubmitDate': '2025-02-28', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-07', 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'NIATx Fidelity', 'timeFrame': '12 months, 24 months', 'description': 'Assess fidelity to the NIATx implementation strategies at two points during the study using a 10-item measure with scores ranging from 0-40 with higher scores indicating stronger fidelity of the intervention.'}], 'primaryOutcomes': [{'measure': 'Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase', 'timeFrame': 'baseline to 12 months', 'description': "The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use."}, {'measure': 'Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase', 'timeFrame': '13 months, 24 months', 'description': "The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use."}, {'measure': 'Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase', 'timeFrame': 'baseline to 12 months', 'description': "The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use."}, {'measure': 'Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase', 'timeFrame': '13 months to 24 months', 'description': "The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use."}, {'measure': 'Change in Number of Prescribers Using MOUD', 'timeFrame': 'baseline, 12 months, 24 months', 'description': 'The adoption of each intervention will be in part measured by tracking the number of prescribers using MOUD at each time point.'}], 'secondaryOutcomes': [{'measure': 'MOUD Sustainability Measured Using the Program Sustainability Assessment Tool', 'timeFrame': 'baseline, 12 months, 24 months', 'description': 'The maintenance of the intervention (MOUD Sustainability) will be measured using the Program Sustainability Assessment Tool included in the Staff Survey at three points during the study (baseline, 12-months \\& 24-months) to determine if likelihood of sustainability increases as study progresses. This tool has a total possible range of scores from 0-63 with higher scores indicating increased sustainability of the intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MOUD', 'OUD', 'Justice Populations', 'Jails', 'ECHO', 'NIATx', 'Inter-agency'], 'conditions': ['Opioid-use Disorder', 'Recidivism']}, 'referencesModule': {'references': [{'pmid': '39901259', 'type': 'RESULT', 'citation': 'Molfenter T, Vechinski J, Kim JS, Zhang J, Meng L, Tveit J, Madden L, Taxman FS. Assessing the comparative effectiveness of ECHO and coaching implementation strategies in a jail/provider MOUD implementation trial. Implement Sci. 2025 Feb 3;20(1):7. doi: 10.1186/s13012-025-01419-6.'}]}, 'descriptionModule': {'briefSummary': 'The grant will test two timely and successful evidence-based implementation practices, NIATx Coaching and ECHO, with jail/community-based healthcare providers to increase medication assisted treatment (MAT) use with justice populations.', 'detailedDescription': 'In this trial, the investigators will test two implementation interventions being applied to medications for opioid use disorder (MOUD) dissemination and implementation in justice settings for justice-involved populations: NIATx Coaching and the Extension for Community Healthcare Outcomes (ECHO) model. NIATx Coaches provide expertise in MOUD implementation and organizational change to help treatment organizations and staff make, sustain, and spread MOUD. The ECHO platform focuses only on the provider side by connecting the primary care provider with expert MOUD prescribers to promote high-quality MOUD practices. This will be the first trial that assesses the comparative effectiveness of these approaches overall, and in justice settings.\n\nThe trial will be conducted with a combination of 48 jails and community-based organizations that treat individuals with opioid use disorders (OUDs) post-incarceration. Sites will be randomly assigned to one of four study arms, with 12 sites in each arm: High-Dose Coaching/ECHO, Low-Dose Coaching/ECHO, High-Dose Coaching/No ECHO, and Low-Dose Coaching/No ECHO. The intervention period will be over a 12-month span with an additional 12-months for sustainability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Site Inclusion Criteria:\n\n* Have an interest in embedding or increasing the use of MOUD within their site.\n* Have the funds to pay for medications for the duration of the study (24 months); whether it be from grants, insurance or private pay.\n* Sites agree to implement or continue to use at least one medication, although they will be encouraged to offer more than one medication.\n* Have leadership support at all levels.\n* Agree to provide data described in the MOU or Information Sheet.\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT04363320', 'briefTitle': 'Fostering MAT Use in Justice Populations', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Fostering MAT Use in Justice Populations', 'orgStudyIdInfo': {'id': '2019-1473'}, 'secondaryIdInfos': [{'id': '3U2CDA050097-01S1', 'link': 'https://reporter.nih.gov/quickSearch/3U2CDA050097-01S1', 'type': 'NIH'}, {'id': '20200548', 'type': 'OTHER', 'domain': 'WIRB protocol number'}, {'id': 'A195010', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'ENGR/CHESS PROGRAM', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls', 'interventionNames': ['Behavioral: NIATx Coaching', 'Behavioral: ECHO']}, {'type': 'EXPERIMENTAL', 'label': 'Low-Dose NIATx Coaching & ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team\n* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls', 'interventionNames': ['Behavioral: NIATx Coaching', 'Behavioral: ECHO']}, {'type': 'EXPERIMENTAL', 'label': 'High-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* 12 monthly (one-hour) coaching calls with Change Leader/Team', 'interventionNames': ['Behavioral: NIATx Coaching']}, {'type': 'EXPERIMENTAL', 'label': 'Low-Dose NIATx Coaching & No ECHO', 'description': '* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \\& Coaches\n* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team', 'interventionNames': ['Behavioral: NIATx Coaching']}], 'interventions': [{'name': 'NIATx Coaching', 'type': 'BEHAVIORAL', 'description': 'NIATx framework provides each participating site with a NIATx Coach who is an expert in MOUD implementation and organizational change and will help the organization adopt, implement, and increase the use of MOUD. Coaches help the sites think through key issues, offer process improvement training, and suggest changes.', 'armGroupLabels': ['High-Dose NIATx Coaching & ECHO', 'High-Dose NIATx Coaching & No ECHO', 'Low-Dose NIATx Coaching & ECHO', 'Low-Dose NIATx Coaching & No ECHO']}, {'name': 'ECHO', 'type': 'BEHAVIORAL', 'otherNames': ['Extension for Community Healthcare Outcomes'], 'description': 'The ECHO model connects MOUD prescribers and experts with primary care providers and medical teams to promote high-quality MOUD practices. ECHO is provided monthly through videoconferences. Experienced MOUD prescribers address topics such as counseling strategies, urine test interpretation, and transitioning from buprenorphine, naltrexone and methadone.', 'armGroupLabels': ['High-Dose NIATx Coaching & ECHO', 'Low-Dose NIATx Coaching & ECHO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53706', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Todd Molfenter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}, {'name': 'Faye Taxman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Mason University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'George Mason University', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}