Emergency Medical Services (EMS)-Initiated Buprenorphine
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Yale University
- Enrollment
- 495
- Locations
- 3
- Primary Endpoint
- Primary Outcome Measure for Pragmatic Field Study
Overview
Brief Summary
This is a multisite EMS study that will first conduct a sequence of pragmatic, prehospital field studies to provide preliminary feasibility, acceptability, and safety data for refinement and enhancement of a subsequent single-arm prospective trial that will provide preliminary effectiveness data, from which to build a larger randomized control trail (RCT) trial.
Detailed Description
Evaluating the EMS clinical protocol details and subsequent research procedures will be accomplished by enrolling approximately five EMS-initiated BUP encounters per site. Subsequently, a pragmatic field study will engage approximately thirty successful BUP initiations to assess the feasibility, acceptability, and safety of the EMS clinical protocol and follow up procedures. Investigators will also enroll a cohort of up to thirty patients per site who are eligible for BUP but refuse for informative purposes only, to understand reasons for refusal. Qualitative data on the refusal cohort will be analyzed separately. The outcomes of the pragmatic studies will inform revisions to the EMS clinical protocol.
A single-arm prospective trial of approximately 100 patients per site will subsequently be conducted to collect preliminary data on the effectiveness of EMS-initiated BUP on engagement in MOUD treatment within 10 and 30 days after the EMS-initiated BUP encounter.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older
- •Treated by the EMS-Initiated buprenorphine clinical protocol which includes:
- •Patients that accept EMS-Initiated BUP protocol. Patients offered the EMS-Initiated BUP protocol but declined.1
- •Willing to follow study procedures.
- •Able to speak English sufficiently to understand study procedures, and to provide verbal and electronic/written consent.
Exclusion Criteria
- •Patients who lack decision making capacity
- •Patients who are in police or protective custody
Arms & Interventions
Participants
Individuals with opioid use disorder (OUD) who encounter Emergency Medical Services (EMS) in the prehospital setting under one of two circumstances: (1) They have experienced an overdose requiring naloxone reversal or (2) They are in acute opioid abstinence withdrawal and are offered an EMS-initiated BUP clinical protocol.
Outcomes
Primary Outcomes
Primary Outcome Measure for Pragmatic Field Study
Time Frame: Baseline
Feasibility and acceptability will be measured by the proportion of patients who accept EMS-initiated BUP among all patients who are offered the EMS-initiated BUP clinical protocol.
Primary Outcome Measure for the Single Arm Prospective Trial
Time Frame: Within 10 days after EMS encounter
The proportion of participants engaged in MOUD within 10 days post EMS-initiated BUP among participants who received BUP and consented to be followed
Secondary Outcomes
- Engagement in Treatment (30)(Within 30 days after EMS encounter)
- Precipitated Withdrawal(Baseline)
- ED Visits and Hospitalizations(Within 30 days after EMS encounter)
- Adverse Events(Within 30 days after EMS-BUP encounter)