Opioid Use Disorder in the Emergency Department: CTN 0069

Overview

The purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF) on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) treatment with referral for ongoing medication-assisted treatment (MAT) and the (2) effectiveness of IF on patient engagement in formal addiction treatment at 30 days.

Full Title of Study: “Opioid Use Disorder in the Emergency Department: Clinical Trials Network-0069″

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2020

Detailed Description

The study uses a Hybrid Type 3 Effectiveness-Implementation framework and a modified stepped wedge design. The study will be conducted at four EDs with a high prevalence of patients with untreated opioid use disorder (OUD). The four sites will receive the same sequence of evaluations and interventions: the baseline evaluation period after the standard dissemination practice, the IF phase, and continuation of facilitation into the IF evaluation period. The timing of initiation of the study activities at each site will be randomly offset by ~ 3 month increments to accommodate logistical constraints of simultaneous implementation at all sites. The study populations will include (1) ED providers and staff involved in the treatment of patients with OUD; (2) Community opioid treatment provider and program staff involved in providing care for patients with OUD referred from the ED; and (3) ED patients with moderate to severe OUD.

Interventions

  • Other: Standard Dissemination Practice
    • Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.
  • Other: Implementation Facilitation (IF)
    • IF involves a “formative evaluation” to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.

Arms, Groups and Cohorts

  • Experimental: Evidenced-based Practice Dissemination
    • Evaluating standard dissemination practice compared with implementation facilitation

Clinical Trial Outcome Measures

Primary Measures

  • Implementation (Considered the Primary Outcome)
    • Time Frame: 12 months
    • The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT over the 12 month period.
  • Effectiveness
    • Time Frame: 30 Days Post Enrollment
    • The primary effectiveness outcome is defined as the rates of patient engagement in formal addiction treatment on the 30th day post enrollment.

Secondary Measures

  • Implementation: Fidelity
    • Time Frame: Baseline Period (Baseline)
    • Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.
  • Implementation: Fidelity
    • Time Frame: IF Evaluation Period (18 months)
    • Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.
  • Implementation: ED provider Readiness and Preparedness Ruler Score
    • Time Frame: Pre IF (Baseline)
    • ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
  • Implementation: ED provider Readiness and Preparedness Ruler Score
    • Time Frame: Post IF (6 months)
    • ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
  • Implementation: ED provider Readiness and Preparedness Ruler Score
    • Time Frame: post IF Evaluation Period (12 months)
    • ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
  • Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score
    • Time Frame: Pre IF (Baseline)
    • ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
  • Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score
    • Time Frame: Post IF (6 months)
    • ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
  • Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score
    • Time Frame: Post IF Evaluation Period (12 months)
    • ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
  • Implementation: Community Readiness and Preparedness Ruler Score
    • Time Frame: Pre IF (Baseline)
    • Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
  • Implementation: Community Readiness and Preparedness Ruler Score
    • Time Frame: Post IF (6 months)
    • Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
  • Implementation: Community Readiness and Preparedness Ruler Score
    • Time Frame: post IF Evaluation Period (12 months)
    • Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
  • Implementation: Community ORCA Score
    • Time Frame: Pre IF (Baseline)
    • Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
  • Implementation: Community ORCA Score
    • Time Frame: Post IF (6 months)
    • Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
  • Implementation: Community ORCA Score
    • Time Frame: post IF Evaluation Period (12 months)
    • Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
  • Effectiveness: Opioid Use
    • Time Frame: 30 days post enrollment
    • Self-reported days of illicit opioid use (past 7 days) as measured by Time-Line Follow-Back methods at 30 days
  • Effectiveness: Overdose Event
    • Time Frame: 30 days post enrollment
    • Overdose event (past 30 days) captured by participant self-report, state medical examiner records, National Death Index and review of medical records
  • Effectiveness: HIV Risk
    • Time Frame: 30 days post enrollment
    • HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale
  • Effectiveness: Healthcare Service Utilization
    • Time Frame: 30 days post enrollment
    • All Healthcare Service Utilization Inpatient and Outpatient
  • Effectiveness: Illicit Opioid Urine Toxicology
    • Time Frame: 30 days post enrollment
    • Rates of illicit opioid negative urines

Participating in This Clinical Trial

Patient Inclusion Criteria:

  • Patients who are treated in the ED during study screening hours with Diagnostic and Statistical Manual (DSM)-5 criteria for moderate to severe OUD and provide an opioid positive urine sample will be eligible to participate.

Patient Exclusion Criteria:

  • Patients who test positive for fentanyl only are not eligible due to lack of uniformly available rapid urine tests.
  • Patients will be excluded if they have a medical or psychiatric condition requiring hospitalization at the index ED visit, are acutely suicidal or severely cognitively impaired precluding informed consent, present from an extended care facility, require continued prescription opioids for a pain condition, are a prisoner or in police custody at time of index ED visit, are currently (past 30 days) enrolled in formal addiction treatment including by court order, are unable to provide 2 contact numbers, are unwilling to follow study procedures, have been previously enrolled in the current study or do not speak English.

ED and Community Participants Inclusion Criteria:

  • ED and community providers and administrators (i.e. physicians, residents, fellows, nursing, nurse practitioners, physician assistants, pharmacists, social workers, counselors, administrative directors, office-based physicians and opioid treatment program representatives) as well as ED patients with OUD.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yale University
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gail D’Onofrio, MD, MS, Principal Investigator, Department of Emergency Medicine, Yale School of Medicine
    • David A Fiellin, MD, Principal Investigator, Department of Internal Medicine, Yale School of Medicine
  • Overall Contact(s)
    • Gail D’Onofrio, MD, MS, 203-785-4404, gail.donofrio@yale.edu

References

D'Onofrio G, O'Connor PG, Pantalon MV, Chawarski MC, Busch SH, Owens PH, Bernstein SL, Fiellin DA. Emergency department-initiated buprenorphine/naloxone treatment for opioid dependence: a randomized clinical trial. JAMA. 2015 Apr 28;313(16):1636-44. doi: 10.1001/jama.2015.3474.

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