search
Back to results

Brief Intervention for Drug Misuse in the Emergency Department (BIDMED)

Primary Purpose

Substance Abuse Detection, HIV, Hepatitis B

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brief motivational intervention
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse Detection

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Assessment and brief intervention

Outcomes

Primary Outcome Measures

Reduction in past 30 day drug misuse
Reduction in behaviors associated with drug misuse
Reduction negative physical health, psychosocial health, and socioeconomic consequences

Secondary Outcome Measures

Uptake of HIV and hepatitis B/C screening

Full Information

First Posted
May 10, 2010
Last Updated
June 8, 2015
Sponsor
Rhode Island Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT01124591
Brief Title
Brief Intervention for Drug Misuse in the Emergency Department
Acronym
BIDMED
Official Title
Clinical Trial to Determine the Effect of a Brief Behavioral Intervention in Reducing Drug Misuse Among an Emergency Department Population
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse Detection, HIV, Hepatitis B, Hepatitis C, Brief Intervention, HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1030 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Assessment and brief intervention
Intervention Type
Behavioral
Intervention Name(s)
Brief motivational intervention
Intervention Description
two session delivered two weeks apart
Primary Outcome Measure Information:
Title
Reduction in past 30 day drug misuse
Time Frame
12 months post-randomization
Title
Reduction in behaviors associated with drug misuse
Time Frame
12 months post-randomization
Title
Reduction negative physical health, psychosocial health, and socioeconomic consequences
Time Frame
12 months post-randomization
Secondary Outcome Measure Information:
Title
Uptake of HIV and hepatitis B/C screening
Time Frame
3 months post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland C Merchant, MD; ScD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ted Nirenberg, PhD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29437758
Citation
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.
Results Reference
derived
PubMed Identifier
26482090
Citation
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.
Results Reference
derived
PubMed Identifier
26375468
Citation
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.
Results Reference
derived
PubMed Identifier
24983020
Citation
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.
Results Reference
derived
PubMed Identifier
25830171
Citation
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.
Results Reference
derived

Learn more about this trial

Brief Intervention for Drug Misuse in the Emergency Department

We'll reach out to this number within 24 hrs