Emergency Department Outcomes for Patients With Opioid Use Disorder

Opioid-use Disorder Clinical Trial

Official title:

Emergency Department Outcomes for Patients With Opioid Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289363
• Other study ID #: 19-01444
• Secondary ID: 3UG1DA013035-18S
• Status: Completed
• Start date: November 25, 2020
• Est. completion date: February 18, 2022

Study information

• Verified date: June 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 18, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Bellevue Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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