Emergency Department Outcomes for Patients With Opioid Use Disorder

NCT04289363 | Completed Results DMC

• 2 other identifiers: 19-014443UG1DA013035-18S3
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

Using mixed methods and triangulating multiples sources of data collected over the course of the parent (CTN-0079 - NCT03544112) and the ancillary studies to evaluate the feasibility, acceptability, sustainability and impact of the emergency department (ED)-initiated Buprenorphine (BUP) clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (2)

• Percent of Participants Who Received Emergency Department (ED)-Initiated/Expedited Buprenorphine (BUP)

  The outcome will be calculated using the following formula: \[(Candidates who receive ED-initiated BUP with any disposition) + (Candidates who receive ED-expedited BUP and who are discharged)\] / \[(Candidates who are discharged) + (Candidates who receive ED-initiated BUP that are not discharged)\].

  Up to Month 12

• Percent of Participants Who Received ED-Initiated/Expedited BUP Who Were Confirmed to be Engaged in Formal Addiction Treatment for Opioid Use Disorder (OUD) on the 30th Day Following Discharge

  The outcome will be calculated using the following formula: (participants who are confirmed to be engaged in formal addiction treatment for Opioid Use Disorder (OUD) on the 30th day following discharge / total number of participants who received ED-initiated/expedited BUP).

  Day 30 Post-Discharge (Up to Month 12)

Secondary Outcomes (6)

• Percent of Discharged Participants Who Received ED-Initiated BUP

  Up to Month 12

• Percent of Not-Admitted Participants Who Received ED-Initiated BUP

  Up to Month 12

• Percent of Participants Who Received ED-Initiated BUP

  Up to Month 12

• Percent of Participants Who Received ED-Initiated/Expedited BUP

  Up to Month 12

• Change in Number of Days of Opioid and/or Other Drug Use as Assessed by Timeline Followback (TLFB) Assessment

  Baseline, Day 30

Study Arms (1)

ED patients

Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc.

Behavioral: Clinical program implementation

Interventions

Clinical program implementation BEHAVIORAL

Using mixed methods and triangulating multiple sources of data collected over the course of parent and ancillary studies to evaluate the feasibility, acceptability, sustainability, and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness. Converging provider and patient perspectives and field notes with process measures and intervention outcomes, including proportions screened, treated, and engaged in treatment, will provide explanation to contextualize and better understand feasibility, acceptability, and factors associated with the rate with which the ED-initiated BUP innovation is adopted and how well it is sustained.

ED patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include ED patients.

You may qualify if:

• Qualitative Population:
• Key stakeholder or opinion leader for ED-initiated BUP
• years of age or older
• Full Study Population \& Limited Study Population:
• Be able to speak English sufficiently to understand study procedures
• Be a potential candidate for ED-initiated BUP by meeting either of the 2 criteria:
• Clinical determination: patient is a willing and eligible candidate for ED-initiated BUP or for whom this can be reasonably inferred, including any patient who is administered and/or prescribed BUP as part of the index ED visit.
• Research determination: Both a and b below must be true at the time of study enrollment:
• a) Assessment conducted by an RA indicates that the patient- (all must be true): i. has had nonmedical opioid use within the last 7 days, ii. meets DSM-5 criteria for moderate or severe opioid use disorder (OUD), iii. denies methadone use within 72 hours of ED visit registration, iv. is not engaged in formal medications for opioid use disorder (MOUD) treatment, v. is not prescribed opioids for chronic pain management, vi. reports being interested or "not sure" if interested in receiving BUP as elicited on the ED Health Survey during the index ED visit.
• b) Absence of clinical documentation associated with the ED visit indicating that the patient is not a candidate for ED-initiated BUP.

You may not qualify if:

• Qualitative Population:
• Unwilling or unable to provide consent
• currently in jail, prison, or any inpatient overnight facility
• Full Study Population:
• Unwilling or unable to provide written/electronic informed consent
• Currently engaged in formal MOUD treatment at the time of index ED visit
• Currently in jail, prison or any inpatient overnight facility as required by court of law
• Previous participation as a patient- participant in CTN-0079 or previous participation as a Full Study participant in the current study
• Presents from a medical-based extended care facility
• Current research participant in a substance use intervention study
• Inadequate locator information (unable or unwilling to provide 2 unique means of contact)
• Unable or unwilling to complete research visits at baseline and Day 30.
• Limited Study Population:
• Unwilling or unable to provide written/electronic informed consent
• Currently engaged in formal MOUD treatment at the time of index ED visit

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Bellevue Hospital Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Ryan McCormack
• Organization: NYU Langone Health

Ryan.McCormack@nyulangone.org

2122632862

Study Officials

• Ryan McCormack, MD, MS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: November 25, 2020
• Primary Completion: January 28, 2022
• Study Completion: February 18, 2022
• Last Updated: July 6, 2023
• Results First Posted: July 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data sets for CTN protocols will be available after (1) the primary paper has been accepted for publication, or (2) the data is locked for more than 18 months, whichever comes first.
• Access Criteria: Anyone who wishes to access the data.Any purpose. Data are available indefinitely at https://datashare.nida.nih.gov/

Locations

US (2)