NCT03023930

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,731

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2022

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 21, 2023

Completed
Last Updated

December 18, 2023

Status Verified

November 1, 2023

Enrollment Period

4.3 years

First QC Date

January 10, 2017

Results QC Date

July 15, 2022

Last Update Submit

November 27, 2023

Conditions

Opioid Use Disorder

Keywords

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

  • Implementation (Considered the Primary Outcome)

    The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT

    12 months

  • Effectiveness

    The primary effectiveness outcome is defined as the rates of patient engagement in formal addiction treatment on the 30th day post enrollment.

    30 Days Post Enrollment

Secondary Outcomes (1)

  • Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score

    Pre IF (Baseline)

Other Outcomes (18)

  • Implementation: ED Provider Readiness and Preparedness Ruler Score

    Pre IF (Baseline)

  • Implementation: ED Provider Readiness and Preparedness Ruler Score

    post IF Evaluation Period (12 months)

  • Implementation: ED Provider Readiness and Preparedness Ruler Score

    Post IF (6 months)

  • +15 more other outcomes

Study Arms (1)

Evidenced-based Practice Dissemination

EXPERIMENTAL

Evaluating standard dissemination practice compared with implementation facilitation

Other: Standard Dissemination PracticeOther: Implementation Facilitation (IF)

Interventions

Standard Dissemination PracticeOTHER

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.

Evidenced-based Practice Dissemination
Implementation Facilitation (IF)OTHER

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.

Evidenced-based Practice Dissemination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (6)

  • 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.

    PMID: 25919527BACKGROUND

  • Coupet E Jr, D'Onofrio G, Chawarski M, Edelman EJ, O'Connor PG, Owens P, Martel S, Fiellin DA, Cowan E, Richardson L, Huntley K, Whiteside LK, Lyons MS, Rothman RE, Pantalon M, Hawk K. Emergency department patients with untreated opioid use disorder: A comparison of those seeking versus not seeking referral to substance use treatment. Drug Alcohol Depend. 2021 Feb 1;219:108428. doi: 10.1016/j.drugalcdep.2020.108428. Epub 2020 Nov 26.

    PMID: 33307301BACKGROUND

  • Chawarski MC, Hawk K, Edelman EJ, O'Connor P, Owens P, Martel S, Coupet E Jr, Whiteside L, Tsui JI, Rothman R, Cowan E, Richardson L, Lyons MS, Fiellin DA, D'Onofrio G. Use of Amphetamine-Type Stimulants Among Emergency Department Patients With Untreated Opioid Use Disorder. Ann Emerg Med. 2020 Dec;76(6):782-787. doi: 10.1016/j.annemergmed.2020.06.046. Epub 2020 Aug 8.

    PMID: 32782084BACKGROUND

  • Hawk KF, D'Onofrio G, Chawarski MC, O'Connor PG, Cowan E, Lyons MS, Richardson L, Rothman RE, Whiteside LK, Owens PH, Martel SH, Coupet E Jr, Pantalon M, Curry L, Fiellin DA, Edelman EJ. Barriers and Facilitators to Clinician Readiness to Provide Emergency Department-Initiated Buprenorphine. JAMA Netw Open. 2020 May 1;3(5):e204561. doi: 10.1001/jamanetworkopen.2020.4561.

    PMID: 32391893BACKGROUND

  • D'Onofrio G, Edelman EJ, Hawk KF, Pantalon MV, Chawarski MC, Owens PH, Martel SH, VanVeldhuisen P, Oden N, Murphy SM, Huntley K, O'Connor PG, Fiellin DA. Implementation facilitation to promote emergency department-initiated buprenorphine for opioid use disorder: protocol for a hybrid type III effectiveness-implementation study (Project ED HEALTH). Implement Sci. 2019 May 7;14(1):48. doi: 10.1186/s13012-019-0891-5.

    PMID: 31064390BACKGROUND

  • D'Onofrio G, Edelman EJ, Hawk KF, Chawarski MC, Pantalon MV, Owens PH, Martel SH, Rothman R, Saheed M, Schwartz RP, Cowan E, Richardson L, Salsitz E, Lyons MS, Freiermuth C, Wilder C, Whiteside L, Tsui JI, Klein JW, Coupet E, O'Connor PG, Matthews AG, Murphy SM, Huntley K, Fiellin DA. Implementation Facilitation to Promote Emergency Department-Initiated Buprenorphine for Opioid Use Disorder. JAMA Netw Open. 2023 Apr 3;6(4):e235439. doi: 10.1001/jamanetworkopen.2023.5439.

    PMID: 37017967DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Gail D'Onofrio
Organization
Yale University
gail.donofrio@yale.edu
(203) 785-7059

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Note: Care Providers and Research Associates are masked during Baseline Evaluation Period
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 18, 2017

Study Start

April 3, 2017

Primary Completion

July 16, 2021

Study Completion

April 23, 2022

Last Updated

December 18, 2023

Results First Posted

February 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Locations

US(5)