Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT00607620
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2008-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Disseminating Organizational SBI Services at Trauma Centers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003419', 'term': 'Crisis Intervention'}, {'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dzatzick@uw.edu', 'phone': '206-744-6701', 'title': 'Douglas Zatzick, MD', 'phoneExt': '206', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': "Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate\n\nBrief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing", 'otherNumAtRisk': 409, 'deathsNumAtRisk': 409, 'otherNumAffected': 62, 'seriousNumAtRisk': 409, 'deathsNumAffected': 10, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Usual Care', 'description': "Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate", 'otherNumAtRisk': 469, 'deathsNumAtRisk': 469, 'otherNumAffected': 65, 'seriousNumAtRisk': 469, 'deathsNumAffected': 3, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Patient Health Questionnaire (PHQ-9) Score of >0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 469, 'numAffected': 65}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 409, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 469, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Hazardous Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate\n\nBrief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate"}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.79', 'ciUpperLimit': '0.98', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The investigators will assess at baseline, 6-month and 12-month.', 'description': 'The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a dichotomous measure. AUDIT Scores of ≥8 for men and ≥5 for women indicate hazardous drinking.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up'}, {'type': 'PRIMARY', 'title': 'Alcohol Use Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate\n\nBrief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate"}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '4.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.2', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '6.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-0.3', 'estimateComment': 'The data represented refers to the group mean difference (intervention versus control) of the change score between baseline to 12-months.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The investigators will assess at baseline, 6-month and 12-month.', 'description': 'The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up'}, {'type': 'SECONDARY', 'title': 'Number of Abstinent Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate\n\nBrief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate"}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.2', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '73.4', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.5', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '71.3', 'spread': '1.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '0.4', 'ciUpperLimit': '6.4', 'estimateComment': 'The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The investigators will assess at 6- and 12-month.', 'description': 'The investigators will use the Form 90 to assess the number of days within the last 90 days in which a patient did not consume alcohol.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up'}, {'type': 'SECONDARY', 'title': 'Number of Binge Drinking Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate\n\nBrief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate"}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '1.9', 'estimateComment': 'The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The investigators will assess at 6-month and 12-month.', 'description': 'The investigators will use the Form 90 to assess the number of days in which a male participants consumed ≥5 alcoholic drinks and female participants consumed ≥4 alcoholic drinks', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up'}, {'type': 'SECONDARY', 'title': 'Alcohol Use Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate\n\nBrief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate"}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.99', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '0.99', 'estimateComment': 'The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The investigators will assess at 6-month and 12-month.', 'description': 'The investigators will use the Short Inventory of Problems (SIP) as a continuous measure. The 16-item scale score ranges from 0-48 with higher scores indicating worse outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': "Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate\n\nBrief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"}, {'id': 'FG001', 'title': 'Usual Care', 'description': "Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '409'}, {'groupId': 'FG001', 'numSubjects': '469'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '409'}, {'groupId': 'FG001', 'numSubjects': '469'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'BG000'}, {'value': '469', 'groupId': 'BG001'}, {'value': '878', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': "Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate\n\nBrief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing"}, {'id': 'BG001', 'title': 'Usual Care', 'description': "Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'spread': '14.7', 'groupId': 'BG000'}, {'value': '36.4', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '36.9', 'spread': '14.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '304', 'groupId': 'BG000'}, {'value': '366', 'groupId': 'BG001'}, {'value': '670', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Baseline', 'categories': [{'title': 'White', 'measurements': [{'value': '253', 'groupId': 'BG000'}, {'value': '292', 'groupId': 'BG001'}, {'value': '545', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 878}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-02', 'studyFirstSubmitDate': '2008-01-29', 'resultsFirstSubmitDate': '2017-10-26', 'studyFirstSubmitQcDate': '2008-01-29', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-02', 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Hazardous Drinking', 'timeFrame': 'The investigators will assess at baseline, 6-month and 12-month.', 'description': 'The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a dichotomous measure. AUDIT Scores of ≥8 for men and ≥5 for women indicate hazardous drinking.'}, {'measure': 'Alcohol Use Problems', 'timeFrame': 'The investigators will assess at baseline, 6-month and 12-month.', 'description': 'The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Number of Abstinent Days', 'timeFrame': 'The investigators will assess at 6- and 12-month.', 'description': 'The investigators will use the Form 90 to assess the number of days within the last 90 days in which a patient did not consume alcohol.'}, {'measure': 'Number of Binge Drinking Days', 'timeFrame': 'The investigators will assess at 6-month and 12-month.', 'description': 'The investigators will use the Form 90 to assess the number of days in which a male participants consumed ≥5 alcoholic drinks and female participants consumed ≥4 alcoholic drinks'}, {'measure': 'Alcohol Use Problems', 'timeFrame': 'The investigators will assess at 6-month and 12-month.', 'description': 'The investigators will use the Short Inventory of Problems (SIP) as a continuous measure. The 16-item scale score ranges from 0-48 with higher scores indicating worse outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alcohol Abuse', 'Alcohol Dependence', 'Alcohol Use Disorder', 'Screening', 'Brief Intervention', 'Motivational Interviewing'], 'conditions': ['Alcohol Abuse', 'Alcohol Dependence']}, 'referencesModule': {'references': [{'pmid': '24450612', 'type': 'RESULT', 'citation': 'Zatzick D, Donovan DM, Jurkovich G, Gentilello L, Dunn C, Russo J, Wang J, Zatzick CD, Love J, McFadden C, Rivara FP. Disseminating alcohol screening and brief intervention at trauma centers: a policy-relevant cluster randomized effectiveness trial. Addiction. 2014 May;109(5):754-65. doi: 10.1111/add.12492. Epub 2014 Feb 28.'}, {'pmid': '37085877', 'type': 'DERIVED', 'citation': 'Zatzick D, Palinkas L, Chambers DA, Whiteside L, Moloney K, Engstrom A, Prater L, Russo J, Wang J, Abu K, Iles-Shih M, Bulger E. Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis. Trials. 2023 Apr 21;24(1):288. doi: 10.1186/s13063-023-07313-0.'}]}, 'descriptionModule': {'briefSummary': "The goal of the Disseminating Organizational Screening and Brief Interventions Services (DO-SBIS) investigation is to capitalize on the unique opportunity afforded by the American College of Surgeons' mandate by taking early steps to insure high quality, evidence-based SBI services are implemented and outcomes are assessed. In the first phase of the investigation, SBI services will be assessed for all 190 level I trauma centers in the United States. In the second phase of the investigation, 20 level I trauma centers will be selected for randomization to intervention or control conditions.", 'detailedDescription': 'Each year in the United States approximately 2.5 million individuals are so severely injured that they require inpatient hospital admission. The integration of screening and brief interventions (SBI) into acute injury care has the potential to markedly increase the number of patients who receive needed services and has been a longstanding public health objective. In January of 2005 the American College of Surgeons, the primary agency responsible for developing trauma center requirements, passed a landmark resolution mandating that level I trauma centers must screen injured patients for an alcohol use disorder, and provide an intervention to those who screen positive. Preliminary studies suggest that there is a substantial risk that the SBI mandate will be implemented with marked variability and that low quality SBI procedures could become the default standard of trauma center care.\n\nProviders at each intervention trauma center will receive workshop training and ongoing telephone coaching in the delivery of evidence-based motivational interviewing (MI) intervention; MI training will be embedded within evidence-based organizational development activities that aim to facilitate the integration of SBI services into routine trauma center care. Control trauma centers will implement SBI care as usual. The investigation hypothesizes that intervention trauma centers, when compared to control trauma centers, will demonstrate higher quality SBI, as evidenced by greater provider proficiency in SBI delivery, significant reductions in 6- and 12-month post-injury alcohol use in patients receiving SBI, and enhanced organizational acceptance of SBI services. Without DO-SBIS baseline data on SBI services and follow-up RCT data on patient, provider, and organizational outcomes, a critical opportunity to provide empiric support of a historic policy decision to require alcohol services at level I trauma centers could be lost. The DO-SBIS interdisciplinary research group includes trauma surgery opinion leaders who are dedicated to implementing future policy mandates that derive from the DO-SBIS research program. Future mandates will aim to strengthen and refine trauma center delivery of evidence-based SBI services. The dissemination of high quality SBI services at level I trauma centers has the potential to influence alcohol policy in other health care settings nationwide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For provider subjects: staff at trauma centers selected by study\n* For patient subjects: admitted to trauma centers selected by study, positive blood alcohol levels, able to provide two follow-up contacts\n\nExclusion Criteria:\n\n* For Providers: Once a trauma center is selected for participation, providers will be selected from existing hospital staff.\n* For Patients: Patients so severely injured that they cannot participate in study procedures will be excluded;\n* Patients who are admitted after self-inflicted injury, or are psychotic and therefore require more intensive acute interventions, will not be included in the study;\n* Injured hospitalized prisoners are excluded.\n* Children under the age of 18 are excluded.'}, 'identificationModule': {'nctId': 'NCT00607620', 'acronym': 'DO-SBIS', 'briefTitle': 'Disseminating Organizational SBI Services at Trauma Centers', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Disseminating Organizational SBI Services (DO-SBIS) at Trauma Centers', 'orgStudyIdInfo': {'id': '30660'}, 'secondaryIdInfos': [{'id': '1R01AA016102-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01AA016102-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate", 'interventionNames': ['Behavioral: Brief Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': "Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate"}], 'interventions': [{'name': 'Brief Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Motivational Interviewing'], 'description': 'Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Douglas F Zatzick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harborview Injury Prevention and Research Center', 'class': 'OTHER'}, {'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Psychiatry & Behavioral Sciences', 'investigatorFullName': 'Douglas Zatzick', 'investigatorAffiliation': 'University of Washington'}}}}