We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Opioid Use Disorder in the Emergency Department: CTN 0069

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03023930
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : October 24, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
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 : April 3, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : January 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.


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. Effectiveness: HIV Risk [ Time Frame: 30 days post enrollment ]
    HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale

  18. Effectiveness: Healthcare Service Utilization [ Time Frame: 30 days post enrollment ]
    All Healthcare Service Utilization Inpatient and Outpatient

  19. Effectiveness: Illicit Opioid Urine Toxicology [ Time Frame: 30 days post enrollment ]
    Rates of illicit opioid negative urines


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Michael Fiori, MD         
Sub-Investigator: Ethan Cowan, MD         
United States, Ohio
University of Cincinnati Medical Center 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:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03023930     History of Changes
Other Study ID Numbers: 1611018631
5UG1DA015831-15 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 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