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.

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.

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

The study population will include ED patients.

All of the individual participant data collected during the trial, after deidentification

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.

Anyone who wishes to access the data.Any purpose. Data are available indefinitely at https://datashare.nida.nih.gov/

12 Months

Among enrolled patients (participants in the ED Patients arm), serious adverse events and other (non-serious) adverse events were not assessed; only death was assessed. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not intended to be monitored/assessed among patients identified via chart review.