Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-30 @ 11:29 AM
Study NCT ID:
NCT01326169
Status:
COMPLETED
Last Update Posted:
2014-09-11
First Post:
2011-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003419', 'term': 'Crisis Intervention'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 730}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-10', 'studyFirstSubmitDate': '2011-03-28', 'studyFirstSubmitQcDate': '2011-03-29', 'lastUpdatePostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number of patients with alcohol-related negative consequences from baseline to 4, 8, and 12 months post-randomization', 'timeFrame': 'Change from baseline in alcohol-related negatve consequences at 4, 8, and 12 months', 'description': 'Specifically, the effect of the intervention on alcohol-related injuries and alcohol-related psychosocial consequences from baseline at 4, 8, and 12 months post-randomization.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of mechanisms of change model', 'timeFrame': '12 months post-randomization', 'description': 'Determine the moderators and mediators of primary outcomes.'}]}, 'conditionsModule': {'keywords': ['Alcohol', 'brief intervention', 'injuries'], 'conditions': ['Alcohol Drinking']}, 'referencesModule': {'references': [{'pmid': '26585044', 'type': 'DERIVED', 'citation': 'Mello MJ, Baird J, Lee C, Strezsak V, French MT, Longabaugh R. A Randomized Controlled Trial of a Telephone Intervention for Alcohol Misuse With Injured Emergency Department Patients. Ann Emerg Med. 2016 Feb;67(2):263-75. doi: 10.1016/j.annemergmed.2015.09.021. Epub 2015 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to reduce impaired driving, risky driving and alcohol-related negative consequences among injured emergency department (ED) patients through a telephone brief intervention. This study will allow researchers to test a novel method of brief intervention that has the potential to be convenient and efficient mechanism to deliver an intervention to an at-risk population. Eligible patients will be consented in the ED, will receive an assessment and then will be randomized into one of two conditions: 1) telephone brief intervention or 2) a comparison control group with a home safety educational program. The participant will also receive an appointment for an initial telephone call. Both conditions will be provided over three telephone sessions: the initial call (immediately following randomization) and two booster calls at 2 weeks and 6 weeks after randomization. Participants will provide information about their alcohol use, alcohol-related injuries, impaired driving, and other driving related negative consequences at 4, 8, and 12 months post-randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English or Spanish speaking\n* Age greater than 17 years\n* ASSIST score \\>=11\n* Injured Emergency Department patient at time of consent\n\nExclusion Criteria:\n\n* Medically unable to give consent\n* Not English or Spanish speaking\n* Homeless\n* Cannot be contacted by telephone'}, 'identificationModule': {'nctId': 'NCT01326169', 'acronym': 'ReDIAL', 'briefTitle': 'ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rhode Island Hospital'}, 'officialTitle': 'ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients', 'orgStudyIdInfo': {'id': '1R01AA017895', 'link': 'https://reporter.nih.gov/quickSearch/1R01AA017895', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'No intervention', 'interventionNames': ['Behavioral: Standard care']}, {'type': 'EXPERIMENTAL', 'label': 'Counseling', 'description': 'Telephone-delivered counseling', 'interventionNames': ['Behavioral: Brief intervention']}], 'interventions': [{'name': 'Brief intervention', 'type': 'BEHAVIORAL', 'description': 'Telephone-delivered counseling', 'armGroupLabels': ['Counseling']}, {'name': 'Standard care', 'type': 'BEHAVIORAL', 'description': 'No intervention', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Michael J Mello, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rhode Island Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael J. Mello, MD, MPH', 'investigatorAffiliation': 'Rhode Island Hospital'}}}}