Emergency Department Outcomes for Patients With Opioid Use Disorder

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.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Behavioral: Clinical program implementation

Detailed Description

The ancillary study will use mixed-methods combining quantitative and qualitative inquiry (interview/focus group and field notes) with administrative and health record data with some analyses including data collected from the parent CTN-0079 (NCT03544112) study. Further, qualitative data will be analyzed in the context of themes derived from CTN-0069 (NCT03023930) and CTN-0079. CTN-0079-A1 is planned to be conducted at two of the three sites of the parent study: (1) Catholic Medical Center, Manchester, New Hampshire; (2) Bellevue/NYU Health and Hospitals, New York, NY. Many of the methods, operating procedures, measures and forms will be retained or adapted from the parent study. However, CTN-0079-A1 is a new study in which lessons learned through the parent study have informed important design modifications necessary to improve study rigor and utility.

As in the parent study, CTN-0079, all clinical care (BUP and referral) will be delivered as part of each facility's clinical protocol, rather than as a research procedure. Implementation Facilitation (IF) activities will continue during ancillary trial preparation with a more intensive booster of IF activities occurring in the last month prior to trial commencement. Thereafter, all study IF support will cease and ancillary study data collection will begin. Data collection will occur over a course of approximately 12 months, divided into two 6-month study periods - the Post-IF and Maintenance Periods. A period of at least 6 months should separate the beginning of the Maintenance Period from the time of last study intervention.

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New York
    • New York, New York, United States, 10016
      • Bellevue Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include ED patients.

Description

Inclusion Criteria:

Qualitative Population:

• Key stakeholder or opinion leader for ED-initiated BUP
• 18 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:

  1. 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.
  2. 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.

Exclusion Criteria:

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
• Currently in jail, prison or any inpatient overnight facility as required by court of law
• Previous participation in the current study as a Limited study or Full study participant
• Presents from a medical-based extended care facility

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Behavioral: Clinical program implementation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Discharged Participants Who Received ED-Initiated BUP	The outcome will be calculated using the following formula: [(ED-initiated, discharged) + (ED-expedited, discharged)] / All candidates who were discharged	Up to Month 12
Percent of Not-Admitted Participants Who Received ED-Initiated BUP	The outcome will be calculated using the following formula: (ED-initiated, not admitted) /All candidates who were not admitted	Up to Month 12
Percent of Participants Who Received ED-Initiated BUP	The outcome will be calculated using the following formula: (ED-initiated, all) / [All discharged candidates + (ED-initiated, not discharged)]	Up to Month 12
Percent of Participants Who Received ED-Initiated/Expedited BUP	The outcome will be calculated using the following formula: (ED-initiated/expedited, all) / [All discharged candidates + (ED-initiated/expedited, not discharged)]	Up to Month 12
Change in Number of Days of Opioid and/or Other Drug Use as Assessed by Timeline Followback (TLFB) Assessment	The TLFB assessment will elicit the participant's self-reported use of illicit substances over the previous 7 days. At the Day 30 follow-up visit the assessment period will be the 7 days preceding the Day 30 post index ED visit.	Baseline, Day 30
Change in Number of Self-Reported Opioid-Related Overdose Events	Participants will be asked to report the number of opioid-related overdose events experienced in the past 30 days through a self-report form.	Baseline, Day 30

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Ryan McCormack, MD, MS, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Actual): January 28, 2022
• Study Completion (Actual): February 18, 2022

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Disease Attributes; Narcotic-Related Disorders; Substance-Related Disorders; Emergencies; Opioid-Related Disorders
• Other Study ID Numbers: 19-01444; 3UG1DA013035-18S3 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification
• IPD Sharing 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.
• IPD Sharing Access Criteria: Anyone who wishes to access the data.Any purpose. Data are available indefinitely at https://datashare.nida.nih.gov/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No