Emergency Medical Services (EMS)-Initiated Buprenorphine
Yale University
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.
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…
Eligibility
- Age range
- Not specified
- Sex
- All
- 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
Locations (3)
- Alameda Health SystemOakland, California
- Hennepin HealthcareMinneapolis, Minnesota
- Cooper University HospitalCamden, New Jersey