Opioid Use Disorder in the Emergency Department: CTN 0069 - Full Text View

Purpose

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.

Condition	Intervention
Opioid Use Disorder	Other: Standard Dissemination Practice Other: Implementation Facilitation (IF)


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Masking Description: Note: Care Providers and Research Associates are masked during Baseline Evaluation Period Primary Purpose: Health Services Research
Official Title:	Opioid Use Disorder in the Emergency Department: Clinical Trials Network-0069

Further study details as provided by Yale University:

Primary Outcome 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 Outcome 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


Estimated Enrollment:	2000
Actual Study Start Date:	April 3, 2017
Estimated Study Completion Date:	January 2021
Estimated Primary Completion Date:	July 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Evidenced-based Practice Dissemination Evaluating standard dissemination practice compared with implementation facilitation	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

Assigned Interventions

Experimental: Evidenced-based Practice Dissemination

Evaluating standard dissemination practice compared with implementation facilitation

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.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03023930

Contacts


Contact: Gail D'Onofrio, MD, MS	203-785-4404	gail.donofrio@yale.edu
Contact: David Fiellin, MD	203-737-3347	david.fiellin@yale.edu

Locations


United States, Maryland
Johns Hopkins Hospital	Recruiting
Baltimore, Maryland, United States, 21287
Contact: Richard Rothman, MD, PhD 410-735-6428 rrothma1@jhmi.edu
Principal Investigator: Richard Rothman, MD, PhD
Sub-Investigator: Robert Schwartz, MD
United States, New York
The Mount Sinai Hospital	Recruiting
New York, New York, United States, 10029
Contact: Lynne Richardson, MD 212-824-8066 lynne.richardson@mssm.edu
Principal Investigator: Lynne Richardson, MD
Sub-Investigator: Richard Rosenthal, MD
United States, Ohio
University of Cincinnati Medical Center	Not yet recruiting
Cincinnati, Ohio, United States, 45219
Contact: Michael Lyons, MD, MPH 513-558-0890 lyonsme@ucmail.uc.edu
Principal Investigator: Michael Lyons, MD, MPH
Sub-Investigator: Christine Wilder, MD
United States, Washington
Harborview Medical Center	Not yet recruiting
Seattle, Washington, United States, 98104
Contact: Lauren Whiteside, MD, MS 203-744-8464 laurenkw@uw.edu
Principal Investigator: Lauren Whiteside, MD
Sub-Investigator: Judith Tsui, MD

Sponsors and Collaborators

Yale University

National Institute on Drug Abuse (NIDA)

The EMMES Corporation

Investigators


Principal Investigator:	Gail D'Onofrio, MD, MS	Department of Emergency Medicine, Yale School of Medicine
Principal Investigator:	David A Fiellin, MD	Department of Internal Medicine, Yale School of Medicine

More Information

Publications:

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.


Responsible Party:	Yale University
ClinicalTrials.gov Identifier:	NCT03023930 History of Changes
Other Study ID Numbers:	1611018631 5UG1DA015831-15 ( U.S. NIH Grant/Contract )
Study First Received:	January 10, 2017
Last Updated:	July 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Yale University:


Opioid Use Disorder

Additional relevant MeSH terms:


Disease Emergencies Pathologic Processes Disease Attributes Analgesics, Opioid Narcotics	Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 17, 2017