Brief Intervention for Drug Misuse in the Emergency Department (BIDMED)
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Purpose
Although screening, brief intervention, and referral to treatment (SBIRT) approaches are effective in reducing alcohol misuse and its associated risk-taking behaviors and negative consequences, there is little research demonstrating the effectiveness of SBIRT for illicit and/or prescription drug misuse. Misusers of illicit and/or prescription drugs frequently seek medical care in emergency departments (EDs), particularly for reasons related to their misuse. As a result, the ED is well suited as a site to conduct an analysis of the effectiveness of SBIRT for this population.
The Brief Intervention for Drug Misuse for the Emergency Department (BIDMED) study is a randomized, controlled, trial that will include adult ED patients at a large, academic, trauma center (Rhode Island Hospital) and a community hospital (The Miriam Hospital) who have a subcritical illness or injury and whose screening indicates illicit and/or prescription drug misuse. BIDMED participants will be randomized to receive screening only (SO) or brief intervention (BI) with appropriate referral to treatment. Participants will complete a battery of blinded baseline assessments using standardized instruments as well as adapted instruments specific to the aims of this study. All participants will undergo blinded follow-up assessments at three, six, and twelve months post-randomization. The primary hypotheses addressed in the BIDMED study are that, compared to participants in the SO arm, participants in the BI arm will show a significantly greater reduction in: (1) drug misuse within the prior 30 days at three months post-randomization, (2) behaviors associated with drug misuse at six months post-randomization; and (3) negative physical health, psychosocial health, and socioeconomic consequences at twelve months post-randomization. As a secondary aim, the impact of BI compared to SO will be assessed on participants contacting, enrolling in, and completing a drug treatment program. In addition, the impact of BI compared to SO on increasing uptake of HIV and hepatitis B/C screening will be measured. A mechanisms of change model that addresses the expected mediators and moderators of change to explain the effects of SBIRT in this setting will also be developed and tested. Further, the epidemiology of illicit and/or prescription drug misuse will be assessed in a random sample of ED patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Substance Abuse Detection Acquired Immunodeficiency Syndrome Hepatitis B Hepatitis C Brief Intervention HIV Infections |
Behavioral: Brief motivational intervention |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Clinical Trial to Determine the Effect of a Brief Behavioral Intervention in Reducing Drug Misuse Among an Emergency Department Population |
- Reduction in past 30 drug misuse [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
- Reduction in behaviors associated with drug misuse [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
- Reduction negative physical health, psychosocial health, and socioeconomic consequences [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
- Uptake of HIV and hepatitis B/C screening [ Time Frame: 3 months post randomization ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1100 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
Assessment and brief intervention
|
Behavioral: Brief motivational intervention
two session delivered two weeks apart
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Self-report of illicit and/or prescription drug misuse in the past three-months. Presenting at the emergency department for medical care.
Exclusion Criteria:
Not age appropriate, in custody, medically unstable, actively psychotic, suicidal
-
Contacts and Locations| Contact: Roland C Merchant, MD, ScD | 401-444-5107 | rmerchant@lifespan.org |
| Contact: Janette Baird, PhD | 401-444-2976 | jbaird@lifespan.org |
| United States, Rhode Island | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Principal Investigator: | Roland C Merchant, MD; ScD | Rhode Island Hospital |
| Principal Investigator: | Ted Nirenberg, PhD | Rhode Island Hospital |
More Information
No publications provided
| Responsible Party: | Roland C Merchant; Ted Nirenberg, Rhode Island Hospital |
| ClinicalTrials.gov Identifier: | NCT01124591 History of Changes |
| Other Study ID Numbers: | 0113-09 |
| Study First Received: | May 10, 2010 |
| Last Updated: | February 24, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Emergencies Hepatitis Hepatitis A Hepatitis B Hepatitis C Immunologic Deficiency Syndromes Substance-Related Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Disease Attributes Pathologic Processes Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Hepadnaviridae Infections DNA Virus Infections Flaviviridae Infections Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013