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CompletedNCT03023930Updated Dec 18, 2023Results posted

Opioid Use Disorder in the Emergency Department: CTN 0069

An interventional study of Standard Dissemination Practice and Implementation Facilitation (IF) in Opioid Use Disorder, sponsored by Yale University. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-18.

Sponsored by Yale University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,731
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The study was originally proposed to use a Hybrid Type 3 Effectiveness-Implementation framework and a modified stepped wedge design.

Original protocol registration language: 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.

Exploratory analyses have been added to assess the impact of COVID-19 and social distancing guidance on drug use and drug supply; access to medications for opioid use disorder; and COVID19 disease from the perspectives of patient participants and ED leadership.

Upon results entry, changes were made to reflect that the study design originally was described as a "modified step wedge" but ultimately was not designed or implemented as such, as there was no substantial overlap of the baseline evaluation and IF evaluation periods. Thus, the statistical plan was adjusted accordingly.

02

Conditions studied

  • Opioid Use Disorder

Keywords

  • Opioid Use Disorder
03

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 1,731 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,731 participants (actual)

Study arms

  • Experimental
    Evidenced-based Practice Dissemination

    Evaluating standard dissemination practice compared with implementation facilitation

    Other: Standard Dissemination Practice · Other: Implementation Facilitation (IF)

Interventions

  • OtherStandard 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.

  • OtherImplementation 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

  2. Effectiveness

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

    Time frame: 30 Days Post Enrollment

Secondary outcomes

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

    ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT. Scores are dichotomized as less ready (scores 0-6) or most ready (scores 7-10).

    Time frame: Pre IF (Baseline)

Other outcomes

  1. Implementation: ED Provider Readiness and Preparedness Ruler Score

    ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT.

    Time frame: Pre IF (Baseline)

  2. Implementation: ED Provider Readiness and Preparedness Ruler Score

    ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT

    Time frame: post IF Evaluation Period (12 months)

  3. Implementation: ED Provider Readiness and Preparedness Ruler Score

    ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT

    Time frame: Post IF (6 months)

  4. Effectiveness: Illicit Opioid Urine Toxicology

    Rates of illicit opioid negative urines

    Time frame: 30 days post enrollment

  5. Effectiveness: Healthcare Service Utilization

    All Healthcare Service Utilization Inpatient and Outpatient

    Time frame: 30 days post enrollment

  6. Effectiveness: Overdose Event

    Overdose event (past 30 days) captured by participant self-report, state medical examiner records, National Death Index and review of medical records

    Time frame: 30 days post enrollment

  7. Effectiveness: Opioid Use

    Self-reported days of illicit opioid use (past 7 days) as measured by Time-Line Follow-Back methods at 30 days

    Time frame: 30 days post enrollment

  8. Effectiveness: HIV Risk

    HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale

    Time frame: 30 days post enrollment

  9. Implementation: Community ORCA Score

    Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP

    Time frame: Pre IF (Baseline)

  10. Implementation: Community ORCA Score

    Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP

    Time frame: Post IF (6 months)

  11. Implementation: Community ORCA Score

    Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP

    Time frame: post IF Evaluation Period (12 months)

  12. Implementation: Community Readiness and Preparedness Ruler Score

    Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP

    Time frame: Pre IF (Baseline)

  13. Implementation: Community Readiness and Preparedness Ruler Score

    Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP

    Time frame: Post IF (6 months)

  14. Implementation: Community Readiness and Preparedness Ruler Score

    Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP

    Time frame: post IF Evaluation Period (12 months)

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

    ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT

    Time frame: Post IF (6 months)

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

    ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT

    Time frame: Post IF Evaluation Period (12 months)

  17. Implementation: Fidelity

    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.

    Time frame: Baseline Period (Baseline)

  18. Implementation: Fidelity

    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.

    Time frame: IF Evaluation Period (18 months)

07

Results

Posted Feb 21, 2023

Participant flow

A total of 27,748 patients were screened during the baseline evaluation period and 394 were enrolled and analyzed. During the IF evaluation period, 26,456 were screened and 362 enrolled and analyzed. The study was originally conceived as a "modified step wedge" but not designed or implemented as such, as there was no substantial overlap of the baseline evaluation and IF evaluation periods. A total of 975 unique providers were assessed across the study periods via survey.

Participant flow — Overall Study
MilestoneBaseline Evaluation Period CohortIF Evaluation PeriodProviders - Baseline PeriodProviders - 6 Month PeriodProviders - 12 Month Period
Started39436270692177
Completed39436270692177
Not completed00000

Outcome measures

PrimaryImplementation (Considered the Primary Outcome)

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

Time frame:
12 months
Reported as:
Count of participants · Participants
Implementation (Considered the Primary Outcome)
ParticipantsBaseline Evaluation Period CohortIF Evaluation Period Cohort
Implementation (Considered the Primary Outcome)253
Statistical analysis
  • Baseline Evaluation Period Cohort vs IF Evaluation Period Cohort · Regression, Logistic · p = <0.001proc logistic
PrimaryEffectiveness

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

Time frame:
30 Days Post Enrollment
Reported as:
Count of participants · Participants
Effectiveness
ParticipantsBaseline Evaluation Period CohortIF Evaluation Period Cohort
Effectiveness4059
Statistical analysis
  • Baseline Evaluation Period Cohort vs IF Evaluation Period Cohort · Regression, Logistic · p = 0.011proc logistic
SecondaryImplementation: ED Organizational Readiness to Change Assessment (ORCA) Score

ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT. Scores are dichotomized as less ready (scores 0-6) or most ready (scores 7-10).

Time frame:
Pre IF (Baseline)
Reported as:
Count of participants · Participants
Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score
ParticipantsBaseline Evaluation Period Cohort
Most Ready56
Less Ready212
Other pre-specifiedImplementation: ED Provider Readiness and Preparedness Ruler Score

ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT.

Time frame:
Pre IF (Baseline)

Results for this outcome have not been posted.

Other pre-specifiedImplementation: ED Provider Readiness and Preparedness Ruler Score

ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT

Time frame:
post IF Evaluation Period (12 months)

Results for this outcome have not been posted.

Other pre-specifiedImplementation: ED Provider Readiness and Preparedness Ruler Score

ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT

Time frame:
Post IF (6 months)

Results for this outcome have not been posted.

Other pre-specifiedEffectiveness: Illicit Opioid Urine Toxicology

Rates of illicit opioid negative urines

Time frame:
30 days post enrollment

Results for this outcome have not been posted.

Other pre-specifiedEffectiveness: Healthcare Service Utilization

All Healthcare Service Utilization Inpatient and Outpatient

Time frame:
30 days post enrollment

Results for this outcome have not been posted.

Other pre-specifiedEffectiveness: Overdose Event

Overdose event (past 30 days) captured by participant self-report, state medical examiner records, National Death Index and review of medical records

Time frame:
30 days post enrollment

Results for this outcome have not been posted.

Other pre-specifiedEffectiveness: Opioid Use

Self-reported days of illicit opioid use (past 7 days) as measured by Time-Line Follow-Back methods at 30 days

Time frame:
30 days post enrollment

Results for this outcome have not been posted.

Other pre-specifiedEffectiveness: HIV Risk

HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale

Time frame:
30 days post enrollment

Results for this outcome have not been posted.

Other pre-specifiedImplementation: Community ORCA Score

Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP

Time frame:
Pre IF (Baseline)

Results for this outcome have not been posted.

Other pre-specifiedImplementation: Community ORCA Score

Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP

Time frame:
Post IF (6 months)

Results for this outcome have not been posted.

Other pre-specifiedImplementation: Community ORCA Score

Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP

Time frame:
post IF Evaluation Period (12 months)

Results for this outcome have not been posted.

Other pre-specifiedImplementation: Community Readiness and Preparedness Ruler Score

Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP

Time frame:
Pre IF (Baseline)

Results for this outcome have not been posted.

Other pre-specifiedImplementation: Community Readiness and Preparedness Ruler Score

Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP

Time frame:
Post IF (6 months)

Results for this outcome have not been posted.

Other pre-specifiedImplementation: Community Readiness and Preparedness Ruler Score

Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP

Time frame:
post IF Evaluation Period (12 months)

Results for this outcome have not been posted.

Other pre-specifiedImplementation: ED Organizational Readiness to Change Assessment (ORCA) Score

ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT

Time frame:
Post IF (6 months)

Results for this outcome have not been posted.

Other pre-specifiedImplementation: ED Organizational Readiness to Change Assessment (ORCA) Score

ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT

Time frame:
Post IF Evaluation Period (12 months)

Results for this outcome have not been posted.

Other pre-specifiedImplementation: Fidelity

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.

Time frame:
Baseline Period (Baseline)

Results for this outcome have not been posted.

Other pre-specifiedImplementation: Fidelity

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.

Time frame:
IF Evaluation Period (18 months)

Results for this outcome have not been posted.

Adverse events

Collected over Data was collected over 12 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Baseline Evaluation Period Cohort1/394 (0.3%)0/394 (0%)0/394 (0%)
IF Evaluation Period2/362 (0.6%)0/362 (0%)0/362 (0%)

Baseline characteristics

Baseline characteristics were not collected for providers.

Age, Continuous
Age, Continuous(years)Baseline Evaluation Period CohortIF Evaluation Period CohortTotal
Mean38.9 ± 11.739.7 ± 11.739.3 ± 11.7
Sex: Female, Male
Sex: Female, Male(Participants)Baseline Evaluation Period CohortIF Evaluation Period CohortTotal
Female12195216
Male273267540
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Baseline Evaluation Period CohortIF Evaluation Period CohortTotal
Hispanic or Latino493988
Not Hispanic or Latino345323668
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Baseline Evaluation Period CohortIF Evaluation Period CohortTotal
American Indian or Alaska Native121527
Asian347
Native Hawaiian or Other Pacific Islander224
Black or African American110113223
White206188394
More than one race141630
Unknown or Not Reported472471
Region of Enrollment
Region of Enrollment(participants)Baseline Evaluation Period CohortIF Evaluation Period CohortTotal
United States394362756
Education
Education(Participants)Baseline Evaluation Period CohortIF Evaluation Period CohortTotal
Less than high school diploma140126266
High school graduate or equivalent (GED)130146276
Some college, no degree7462136
≥ College degree502878
Employment
Employment(Participants)Baseline Evaluation Period CohortIF Evaluation Period CohortTotal
Working6366129
Unemployed228192420
Disabled permanently or temporarily8062142
Unstable Housing
Unstable Housing(Participants)Baseline Evaluation Period CohortIF Evaluation Period CohortTotal
Shelter for homeless persons102108210
On the street/public place not intended for sleeping191192383
Doubled up in someone else's house apartment190135325

6 further baseline measures are reported on the registry.

08

Study locations

5 sites
  • Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
  • The Mount Sinai Hospital
    New York, New York 10029, United States
  • Weill Cornell Medical College
    New York, New York 10065, United States
  • University of Cincinnati Medical Center
    Cincinnati, Ohio 45219, United States
  • Harborview Medical Center
    Seattle, Washington 98104, United States
09

References and documents

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. PubMed 25919527 ↗
  • 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. PubMed 33307301 ↗
  • 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. PubMed 32782084 ↗
  • 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. PubMed 32391893 ↗
  • 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. PubMed 31064390 ↗

Study documents

  • Study protocol · May 22, 2018
  • Statistical analysis plan · Sep 20, 2021
  • Informed consent form · Oct 18, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03023930
Lead sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
Responsible party
Sponsor
First posted
Jan 18, 2017
Start date
Apr 3, 2017
Primary completion
Jul 16, 2021
Completion
Apr 23, 2022
Results posted
Feb 21, 2023
Last update
Dec 18, 2023

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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