Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-01-02 @ 1:46 PM
Study NCT ID:
NCT00261859
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2005-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Emergency Practitioner (EP)-Performed Alcohol Interventions in the Emergency Department (ED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2005-12-02', 'studyFirstSubmitQcDate': '2005-12-02', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy of brief intervention', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hazardous drinking'], 'conditions': ['Harmful Drinking']}, 'referencesModule': {'references': [{'pmid': '22459448', 'type': 'BACKGROUND', 'citation': "D'Onofrio G, Fiellin DA, Pantalon MV, Chawarski MC, Owens PH, Degutis LC, Busch SH, Bernstein SL, O'Connor PG. A brief intervention reduces hazardous and harmful drinking in emergency department patients. Ann Emerg Med. 2012 Aug;60(2):181-92. doi: 10.1016/j.annemergmed.2012.02.006. Epub 2012 Mar 28."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of an enhanced emergency practitioner (EP) performed brief intervention (BI), namely, the Enhanced Brief Negotiation Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary care provider, followed by a telephone booster intervention performed by trained nurses 1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled clinical trial 900 hazardous and harmful (HH) drinkers will be randomly assigned to one of the 4 conditions. We, the researchers at Yale University, will conduct cost benefit analysis of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via interactive voice response (IVR).', 'detailedDescription': 'A critical need exists to refine and test brief interventions (BI) for Emergency Department (ED) populations with hazardous and harmful (HH) drinking that can be translated into real-world settings; and to enhance the effects of these BIs so they can be maintained over time. The ED is an ideal setting for BIs, as many ED patients who exceed low-risk recommendations do not have contact with either alcohol treatment specialists or visit primary care medical practitioners. This includes a large segment of young adults ages 18-30 whose only contact with the health care system is often an ED visit. The purpose of this study is to evaluate the effectiveness of an enhanced Emergency Practitioner (EP) performed BI, namely, the Enhanced Brief Negotiation Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary care provider, followed by a telephone booster intervention performed by trained nurses 1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled clinical trial 900 HH drinkers will be randomly assigned to one of the 4 conditions. We will conduct cost benefit analysis of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via interactive voice response (IVR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients, 18 years or older, who present to the adult ED at Yale-New Haven Hospital will be screened for exceeding the NIAAA criteria for low-risk drinking\n* Patients may be hazardous "at-risk" drinkers who screen over the limits, but do not currently exhibit medical, social or legal problems as a result of their drinking, or they may be harmful drinkers, presenting with an alcohol associated injury or illness.\n\nExclusion Criteria:\n\nPatients will be excluded for the following reasons:\n\n* Non-English speaking;\n* Alcohol dependence;\n* Current enrollment in a substance abuse treatment program;\n* Current ED visit for acute psychiatric complaint;\n* Condition that precludes interview i.e., life threatening injury/illness;\n* In police custody; or\n* Inability to provide two contact numbers for follow-up.'}, 'identificationModule': {'nctId': 'NCT00261859', 'briefTitle': 'Enhancing Emergency Practitioner (EP)-Performed Alcohol Interventions in the Emergency Department (ED)', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Enhancing EP-Performed Alcohol Interventions in the ED', 'orgStudyIdInfo': {'id': '0303025116'}, 'secondaryIdInfos': [{'id': 'R01AA014963-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01AA014963-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'SCA', 'description': 'Standard Care with Assessment'}, {'type': 'NO_INTERVENTION', 'label': 'SCNA', 'description': 'Standard Care No Assessment'}, {'type': 'EXPERIMENTAL', 'label': 'BNI', 'description': 'Brief Negotiated Interview', 'interventionNames': ['Behavioral: BNI']}, {'type': 'EXPERIMENTAL', 'label': 'EBNI', 'description': 'Enhanced Brief Negotiated Interview', 'interventionNames': ['Behavioral: BNI']}], 'interventions': [{'name': 'BNI', 'type': 'BEHAVIORAL', 'description': 'behavioral- brief intervention', 'armGroupLabels': ['BNI', 'EBNI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital (Adult Emergency Department)', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': "Gail D'Onofrio, MD, MS", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}