Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-02 @ 6:23 PM
Study NCT ID:
NCT01963234
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2013-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arquanbe@wisc.edu', 'phone': '6082627385', 'title': 'Andrew Quanbeck', 'organization': 'University of Wisconsin - Madison'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 year.', 'eventGroups': [{'id': 'EG000', 'title': 'Seva - Patients', 'description': 'Patients will receive access to the Seva mobile health system for drug use disorders.', 'otherNumAtRisk': 268, 'deathsNumAtRisk': 268, 'otherNumAffected': 0, 'seriousNumAtRisk': 268, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Seva - Clinicians', 'description': 'Clinicians who worked at Seva sites were also monitored for Adverse events.', 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 0, 'seriousNumAtRisk': 171, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Death', 'notes': 'These deaths were non-study related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'This was a non-study related death. This participant died of Chronic Obstructive Pulmonary Disease and emphysema.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Implementation Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}, {'units': 'Milestones', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva - Madison Site', 'description': 'We identified 12 milestones for to meet for each site.'}, {'id': 'OG001', 'title': 'Seva - Missoula', 'description': 'We identified 12 milestones for to meet for each site.'}, {'id': 'OG002', 'title': 'Seva - Bronx', 'description': 'We identified 12 milestones for to meet for each site.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 3 years', 'description': 'The number of implementation milestones completed', 'unitOfMeasure': 'milestones', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Milestones', 'denomUnitsSelected': 'Milestones', 'populationDescription': 'These are milestones achieved for each site.'}, {'type': 'PRIMARY', 'title': 'Any Drinking Days in Last 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva', 'description': 'Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.67', 'spread': '4.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.'}, {'type': 'PRIMARY', 'title': 'Risky Drinking Days in the Last 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva', 'description': 'Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.70', 'spread': '2.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.'}, {'type': 'PRIMARY', 'title': 'Illicit Drug-use Within the Last 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva', 'description': 'Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.14', 'spread': '6.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.'}, {'type': 'PRIMARY', 'title': 'Overall Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva', 'description': 'Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.03', 'spread': '7.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. Value was calculated by adding the mental and physical subscale values. Values could range from 8 to 40.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.'}, {'type': 'PRIMARY', 'title': 'Physical Subscale Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva', 'description': 'Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.48', 'spread': '3.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This scare consisted of 4 questions that had scales ranging from 1 to 5. The scores were summed and values could range from 4 to 20.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.'}, {'type': 'PRIMARY', 'title': 'Mental Subscale Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva', 'description': 'Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.77', 'spread': '3.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This consisted of 4 questions that had scaled ranging from 1 to 5. The scores of the scales were summed and values could range from 4 to 20.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.'}, {'type': 'PRIMARY', 'title': 'Patient Had Any Drink Within the Last 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva', 'description': 'Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.'}, {'type': 'PRIMARY', 'title': 'Patient Had Illicit Drug Use Within the Last 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva', 'description': 'Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.'}, {'type': 'PRIMARY', 'title': 'Patient Had Any Drink or Drug Use Within the Last 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva', 'description': 'Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed because data was self reported and patients were allowed to not answer questions if they chose.'}, {'type': 'PRIMARY', 'title': 'Patients, Within the Last 6 Months Have Received Other Addiction Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva', 'description': 'Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patients Partook in HIV Risky Behavior in the Last 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva', 'description': 'Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patients Partook in HIV Testing in the Last 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva', 'description': 'Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed is lower because data is self reported and patients could chose not to answer some questions.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Using System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva', 'description': 'Patients in each of 3 intervention clinics who received access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 years', 'description': 'Analysis for measure was done for the total of all three sites combined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Adoption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva - Clinicians', 'description': 'This is the number of clinicians who work within clinics where Seva was implemented.'}], 'classes': [{'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3 years', 'description': 'We analyzed computerized system log files to produce patterns of system adoption of the staff.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This is the number of primary care clinical staff at the 3 sites who adopted using Seva.'}, {'type': 'SECONDARY', 'title': 'Total Costs for Clinic', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}]}, {'units': 'clinic', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Seva - Madison Site', 'description': 'Patients will receive access to the Seva mobile health system for drug use disorders.'}, {'id': 'OG001', 'title': 'Seva - Missoula', 'description': 'Patients will receive access to the Seva mobile health system for drug use disorders.'}, {'id': 'OG002', 'title': 'Seva - Bronx', 'description': 'Patients will receive access to the Seva mobile health system for drug use disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '123584', 'groupId': 'OG000'}, {'value': '140495', 'groupId': 'OG001'}, {'value': '111298', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'This includes the clinic operating costs and clinic implementation costs of the intervention.', 'unitOfMeasure': 'US dollars', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'clinic', 'denomUnitsSelected': 'clinic', 'populationDescription': 'This outcome measure was analyzed at the clinic level. Thus, NA is indicated for "Overall number of participants analyzed."'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Seva - Patients', 'description': 'Up to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders.'}, {'id': 'FG001', 'title': 'Seva - Clinicians', 'description': 'We will analyze data of clinicians who use Seva (e.g. clinical adoption).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '268'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Seva - Madison Site', 'description': 'Patients will receive access to the Seva mobile health system for drug use disorders. Data on clinician participants were not collected due to the focus of the study being the patient.'}, {'id': 'BG001', 'title': 'Seva - Missoula', 'description': 'Patients will receive access to the Seva mobile health system for drug use disorders. Data on clinician participants were not collected due to the focus of the study being the patient.'}, {'id': 'BG002', 'title': 'Seva - Bronx', 'description': 'Patients will receive access to the Seva mobile health system for drug use disorders. Data on clinician participants were not collected due to the focus of the study being the patient.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Insured by medicare', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insured by medicaid', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insured by private/other', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Not insured', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Patient-centered medical home (PCMH) designation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Site specific.', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Three levels of recognition exist, based on practice sites meeting six standards. Level three clinics have the best adherence to the standards. Those standards include team-based care and practice organization, knowing and managing patients, patient-centered access and continuity, care management and support, care coordination and care transitions, and performance measurement and quality improvement.', 'unitOfMeasure': 'Level'}, {'title': 'Patients enrolled in Seva', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Any drinking days', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '2.53', 'spread': '6.01', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'within the last 30 days.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics.'}, {'title': 'Risky drinking days', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '1.25', 'spread': '3.78', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'within the last 30 days.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics.'}, {'title': 'Illicit drug-use days', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '3.22', 'spread': '7.57', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'within the last 30 days.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics.'}, {'title': 'Overall quality of life (QoL)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '202', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '28.47', 'spread': '6.46', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Higher scores on the scale indicate higher quality of life. Scale ranges from 8 to 40. It includes mental and physical health sub scale values. These values are summed', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics.'}, {'title': 'Physical subscale Quality of Life', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '13.2', 'spread': '3.01', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Higher scores on the scale indicate higher quality of life. It includes 4 items on overall physical health, physical function, pain, and fatigue that each has a scale ranging from 1 to 5. These values are summed. Scale ranges from 4 to 20.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants dropped out over the duration of the study. Data for each specific clinic was not collected and analyzed. Data was collected and analyzed at the total level for all three clinics.'}, {'title': 'Mental subscale Quality of Life', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '204', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '9.75', 'spread': '2.99', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Higher scores on the scale indicate higher quality of life. There are 4 questions that have scales that range from values of 1 to 5. These values are summed to give the score for the mental subscale quality of life. Scale ranges from 4 to 20.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants dropped out of the study over the duration.'}, {'title': 'Number of hospitalizations', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '0.43', 'spread': '1.03', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Within the last 6 months.', 'unitOfMeasure': 'hospitalizations', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants dropped out of the study over the duration.'}, {'title': 'Number of ER visits', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '1.10', 'spread': '2.79', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'within the past 6 months.', 'unitOfMeasure': 'ER visits', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants dropped out over the duration of the study.'}, {'title': 'Any drink', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'within the last 30 days.', 'unitOfMeasure': 'participants', 'populationDescription': 'Participants dropped out over the duration of the study.'}, {'title': 'Illicit drug use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'within the last 30 days.', 'unitOfMeasure': 'participants', 'populationDescription': 'Participants dropped out of the study over time.'}, {'title': 'Any drink or drug', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'within the last 30 days.', 'unitOfMeasure': 'participants', 'populationDescription': 'Participants dropped out of the study over time.'}, {'title': 'Currently receive other addiction treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'within the last 6 months.', 'unitOfMeasure': 'participants', 'populationDescription': 'Participants dropped out over time.'}, {'title': 'HIV risky behavior', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'within the last 6 months.', 'unitOfMeasure': 'participants', 'populationDescription': 'Participants dropped out over time.'}, {'title': 'HIV testing', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'within the past 6 months.', 'unitOfMeasure': 'participants', 'populationDescription': 'Participants dropped out over time.'}, {'title': 'Drug of choice is alcohol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Drug of choice is Opiates', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Drug of choice is crack cocaine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Drug of choice is marijuana', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Drug of choice is methamphetamine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Drug of choice is multiple drugs', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-05', 'size': 826867, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-02-27T11:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-03', 'studyFirstSubmitDate': '2013-10-09', 'resultsFirstSubmitDate': '2018-02-28', 'studyFirstSubmitQcDate': '2013-10-11', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-03', 'studyFirstPostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implementation Status', 'timeFrame': 'up to 3 years', 'description': 'The number of implementation milestones completed'}, {'measure': 'Any Drinking Days in Last 30 Days', 'timeFrame': '6 months'}, {'measure': 'Risky Drinking Days in the Last 30 Days', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.'}, {'measure': 'Illicit Drug-use Within the Last 30 Days', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.'}, {'measure': 'Overall Quality of Life', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. Value was calculated by adding the mental and physical subscale values. Values could range from 8 to 40.'}, {'measure': 'Physical Subscale Quality of Life', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This scare consisted of 4 questions that had scales ranging from 1 to 5. The scores were summed and values could range from 4 to 20.'}, {'measure': 'Mental Subscale Quality of Life', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This consisted of 4 questions that had scaled ranging from 1 to 5. The scores of the scales were summed and values could range from 4 to 20.'}, {'measure': 'Patient Had Any Drink Within the Last 30 Days', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.'}, {'measure': 'Patient Had Illicit Drug Use Within the Last 30 Days', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.'}, {'measure': 'Patient Had Any Drink or Drug Use Within the Last 30 Days', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.'}, {'measure': 'Patients, Within the Last 6 Months Have Received Other Addiction Treatment', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.'}, {'measure': 'Patients Partook in HIV Risky Behavior in the Last 6 Months', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.'}, {'measure': 'Patients Partook in HIV Testing in the Last 6 Months', 'timeFrame': '6 months', 'description': 'Analysis for measure was done for the total of all three sites combined.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Using System', 'timeFrame': 'up to 3 years', 'description': 'Analysis for measure was done for the total of all three sites combined.'}, {'measure': 'Clinical Adoption', 'timeFrame': 'up to 3 years', 'description': 'We analyzed computerized system log files to produce patterns of system adoption of the staff.'}, {'measure': 'Total Costs for Clinic', 'timeFrame': '6 months', 'description': 'This includes the clinic operating costs and clinic implementation costs of the intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Substance Use Disorders', 'HIV']}, 'referencesModule': {'references': [{'pmid': '31237841', 'type': 'DERIVED', 'citation': 'Quanbeck A. Using Stakeholder Values to Promote Implementation of an Evidence-Based Mobile Health Intervention for Addiction Treatment in Primary Care Settings. JMIR Mhealth Uhealth. 2019 Jun 7;7(6):e13301. doi: 10.2196/13301.'}, {'pmid': '27687632', 'type': 'DERIVED', 'citation': "Mares ML, Gustafson DH, Glass JE, Quanbeck A, McDowell H, McTavish F, Atwood AK, Marsch LA, Thomas C, Shah D, Brown R, Isham A, Nealon MJ, Ward V. Implementing an mHealth system for substance use disorders in primary care: a mixed methods study of clinicians' initial expectations and first year experiences. BMC Med Inform Decis Mak. 2016 Sep 29;16(1):126. doi: 10.1186/s12911-016-0365-5."}, {'pmid': '24884976', 'type': 'DERIVED', 'citation': 'Quanbeck AR, Gustafson DH, Marsch LA, McTavish F, Brown RT, Mares ML, Johnson R, Glass JE, Atwood AK, McDowell H. Integrating addiction treatment into primary care using mobile health technology: protocol for an implementation research study. Implement Sci. 2014 May 29;9:65. doi: 10.1186/1748-5908-9-65.'}]}, 'descriptionModule': {'briefSummary': 'Implementing a mobile-phone based system for drug use disorders in primary care settings.', 'detailedDescription': 'The purpose of the research is to study the impact of a recovery support system called Seva on primary care organizations, where issues such as coordination of care, job satisfaction, and the cost of adopting and operating new technologies are critical. The study will also investigate how to best implement this kind of technology into health care delivery systems that care for people diagnosed with substance abuse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatient subjects must be 1) age 18 or older 2) meet criteria for Substance Use Disorder (SUD) according to the clinic. Clinician subjects referring patients will ensure that patients: 3) have no current psychotic disorder severe enough to prevent participation, 4) have no acute medical problem requiring immediate inpatient treatment, 5) are willing to use Seva, and 6) can understand and sign a consent form in English.\n\nClinician subjects include MDs, behavioral health providers, nurses and management staff from the clinics' primary care and behavioral health departments. Clinician must have an interest in the research objectives.\n\nExclusion Criteria:\n\n* Failure to meet inclusion criteria above will exclude patients and clinicians from participating."}, 'identificationModule': {'nctId': 'NCT01963234', 'acronym': 'Seva', 'briefTitle': 'Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)', 'orgStudyIdInfo': {'id': '2012-0937'}, 'secondaryIdInfos': [{'id': 'R01DA034279-01', 'link': 'https://reporter.nih.gov/quickSearch/R01DA034279-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seva', 'description': 'Up to 100 patients in each of 3 intervention clinics will receive access to the Seva mobile health system for drug use disorders.', 'interventionNames': ['Behavioral: Seva']}], 'interventions': [{'name': 'Seva', 'type': 'BEHAVIORAL', 'description': 'Patients were given access to use Seva. This is a mobile application that uses social and behavioral theories to help support people after alcohol use disorder recovery.', 'armGroupLabels': ['Seva']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Partnership Health Center', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Institute for Family Health', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '53706', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW Health Access Clinic', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Dartmouth College', 'class': 'OTHER'}, {'name': 'Center for Health Enhancement System Studies', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}