Comparing Interventions for Opioid Dependent Patients Presenting in Medical Emergency Departments

NCT02586896 | Completed Results DMC

• 1 other identifier: 15-00862
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the effects of brief strengths-based case management (SBCM) to the effects of screening, assessment and referral alone (SAR) in opioid-dependent patients. Participants meeting DSM-IV criteria for opioid dependence will be randomly assigned (150 per group) to receive 1) up to 6 sessions of SBCM; or 2) SAR. Follow-up assessments will be completed at 3 and 6 months, by staff who are blinded to treatment condition.

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (2)

• Initiation of Treatment for Opioid Dependence

  "Initiation" is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D.

  3 months

• Engagement in Treatment for Opioid Dependence

  Using the same timeframe as "initiation," "engagement" is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records.

  3 months

Secondary Outcomes (4)

• Number of Participants With Successful Outcome for Opioid Use

  3 months

• Score on World Health Organization Quality of Life (WHOQoL) Brief Questionnaire

  3 months

• Initiation in Participants With Higher Levels of Environmental Instability at Baseline

  3 months

• Engagement in Participants With Higher Levels of Environmental Instability at Baseline

  3 months

Study Arms (2)

Strengths-based Case Management (SBCM)

EXPERIMENTAL

The structure of SBCM follows the widely accepted functions of case management-assessment, planning, linking, monitoring and advocacy-and the theory-driven gestalt of the strengths perspective. Strengths-based principles include an emphasis on client strengths, teaching clients a method for setting and completing goals, and development of a strong working alliance.

Behavioral: Strengths-based Case Management (SBCM)

Screening, Assessment and Referral (SAR)

ACTIVE COMPARATOR

Following randomization, participants in the SAR condition will be provided with minimal scripted feedback to let them know that their assessment indicates substance dependence, and given a recommendation to seek treatment.

Behavioral: Screening, Assessment, and Referral (SAR)

Interventions

Strengths-based Case Management (SBCM) BEHAVIORAL

The six case management sessions for the proposed trial are based on those described in manuals developed by Dr. Rapp for two clinical trials, one supported by National Institute on Drug Abuse (NIDA) and another by the Centers for Disease Control (CDC). Each session is guided by specific objectives that promote linkage with and retention in substance abuse treatment, particularly pharmacotherapy for opioid dependence in a specialty or primary care setting. Objectives from the earlier trials will be adapted to fit the specific context of this trial, linking with and staying in treatment following an emergency department visit. Initiation of the relationship between client and case manager begins immediately following random assignment and termination takes place when either (1) six sessions have occurred; (2) ninety days have elapsed; or (3) clients discontinue involvement.

Strengths-based Case Management (SBCM)

Screening, Assessment, and Referral (SAR) BEHAVIORAL

The research assistant will provide these participants with an information sheet listing treatment (including both specialty treatment centers and primary care clinics that provide buprenorphine) and self-help resources in their community. The referral sheet includes names, addresses, and phone numbers of local addiction treatment agencies. Because the emergency department does not currently screen or refer systematically, the SAR condition represents a level of care significantly higher than "treatment as usual." Participants will also receive an informational pamphlet about drug use and its consequences, addiction, and treatment.

Screening, Assessment and Referral (SAR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Registration as patient in the ED during study screening hours;
• Endorsement of three or more opioid dependence criteria on the DSM-IV checklist
• Age 18 years or older;
• Adequate English proficiency;
• Ability to provide informed consent;
• Self-report use of opioids in the last 30 days

You may not qualify if:

• Inability to participate due to emergency treatment;
• Significant impairment of cognition or judgment rendering the person incapable of informed consent. (e.g., traumatic brain injury, delirium, intoxication);
• Status as a prisoner or in police custody at the time of treatment;
• Current engagement in substance use disorder treatment;
• Residence more than 50 miles from the location of follow-up visits;
• Inability to provide sufficient contact information (must provide at least 2 reliable locators);
• Unavailable for follow-up (e.g., planning to relocate within 6 months)
• Prior participation in the current study.
• Current participation in a research study related to substance use.

Sponsors & Collaborators

• NYU Langone Health: lead
• Wright State University: collaborator

Study Sites (1)

Bellevue Hospital Center

New York, New York, 10016, United States

Location

Related Publications (1)

• Regis A, Meyers-Ohki SE, Mennenga SE, Greco PP, Glisker R, Kolaric R, McCormack RP, Rapp RC, Bogenschutz MP. Implementation of strength-based case management for opioid-dependent patients presenting in medical emergency departments: rationale and study design of a randomized trial. Trials. 2020 Sep 3;21(1):761. doi: 10.1186/s13063-020-04684-6.

  PMID: 32883337 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Mass Screening; Restraint, Physical; Referral and Consultation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Behavior Control; Therapeutics; Immobilization; Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Michael Bogenschutz
• Organization: NYU School of Medicine

michael.bogenschutz@nyulangone.org

646-501-4026

Study Officials

• Michael P Bogenschutz, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 27, 2015
• Study Start: March 1, 2016
• Primary Completion: April 23, 2019
• Study Completion: April 23, 2019
• Last Updated: May 5, 2020
• Results First Posted: March 23, 2020

Record last verified: 2020-04

Locations

US (1)