Opioid Use Disorder in the Emergency Department: CTN 0069

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT03023930

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), The Emmes Company, LLC (Industry)

2,000

Enrollment

Locations

Arm

51.4

Actual Duration (Months)

400

Patients Per Site

7.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder	Other: Standard Dissemination Practice Other: Implementation Facilitation (IF)	N/A

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

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

Actual Study Start Date :

Apr 3, 2017

Actual Primary Completion Date :

Jul 16, 2021

Actual Study Completion Date :

Jul 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Implementation (Considered the Primary Outcome) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [30 days post enrollment]
HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale
Effectiveness: Healthcare Service Utilization [30 days post enrollment]
All Healthcare Service Utilization Inpatient and Outpatient
Effectiveness: Illicit Opioid Urine Toxicology [30 days post enrollment]
Rates of illicit opioid negative urines

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
2	The Mount Sinai Hospital	New York	New York	United States	10029
3	Weill Cornell Medical College	New York	New York	United States	10065
4	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45219
5	Harborview Medical Center	Seattle	Washington	United States	98104

Sponsors and Collaborators

Yale University
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC

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