Brief Intervention for Drug Misuse in the Emergency Department

NCT ID: NCT01124591

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1030 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

Conditions

Substance Abuse Detection; HIV; Hepatitis B; Hepatitis C; Brief Intervention; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment

Assessment and brief intervention

Group Type: EXPERIMENTAL

Brief motivational intervention

Intervention Type: BEHAVIORAL

two session delivered two weeks apart

Interventions

Brief motivational intervention

two session delivered two weeks apart

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Roland C. Merchant, MD. MPH, ScD

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roland C Merchant, MD; ScD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Ted Nirenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

References

Merchant RC, Zhang Z, Zhang Z, Liu T, Baird JR. Lack of efficacy in a randomised trial of a brief intervention to reduce drug use and increase drug treatment services utilisation among adult emergency department patients over a 12-month period. Emerg Med J. 2018 May;35(5):282-288. doi: 10.1136/emermed-2016-206540. Epub 2018 Feb 2.

Reference Type: DERIVED

PMID: 29437758 (View on PubMed)

Guan W, Liu T, Baird JR, Merchant RC. Evaluation of a brief intervention to reduce the negative consequences of drug misuse among adult emergency department patients. Drug Alcohol Depend. 2015 Dec 1;157:44-53. doi: 10.1016/j.drugalcdep.2015.10.007. Epub 2015 Oct 13.

Reference Type: DERIVED

PMID: 26482090 (View on PubMed)

Merchant RC, Baird JR, Liu T. Short-term Efficacy of a Brief Intervention to Reduce Drug Misuse and Increase Drug Treatment Utilization Among Adult Emergency Department Patients. Acad Emerg Med. 2015 Oct;22(10):1172-80. doi: 10.1111/acem.12767. Epub 2015 Sep 16.

Reference Type: DERIVED

PMID: 26375468 (View on PubMed)

Bernardino VL, Baird JR, Liu T, Merchant RC. Comparison of substance-use prevalence among Rhode Island and The Miriam Hospital Emergency Department patients to state and national general population prevalence estimates. R I Med J (2013). 2014 Apr 1;98(4):30-4.

Reference Type: DERIVED

PMID: 25830171 (View on PubMed)

Merchant RC, Baird JR, Liu T, Taylor LE. HCV among The Miriam Hospital and Rhode Island Hospital Adult ED Patients. R I Med J (2013). 2014 Jul 1;97(7):35-9.

Reference Type: DERIVED

PMID: 24983020 (View on PubMed)

Other Identifiers

0113-09

Identifier Type: -

Identifier Source: org_study_id