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.
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 Type
OBSERVATIONAL
Enrollment
495
Alameda Health System
Oakland, California, United States
RECRUITINGHennepin Healthcare
Minneapolis, Minnesota, United States
RECRUITINGCooper University Hospital
Camden, New Jersey, United States
RECRUITINGPrimary Outcome Measure for Pragmatic Field Study
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.
Time frame: Baseline
Primary Outcome Measure for the Single Arm Prospective Trial
The proportion of participants engaged in MOUD within 10 days post EMS-initiated BUP among participants who received BUP and consented to be followed
Time frame: Within 10 days after EMS encounter
Engagement in Treatment (30)
The proportion of patients participating in MOUD treatment
Time frame: Within 30 days after EMS encounter
Precipitated Withdrawal
The proportion of patients who develop precipitated withdrawal among all those who accepted EMS buprenorphine.
Time frame: Baseline
ED Visits and Hospitalizations
Proportion of patients with subsequent ED visits and hospitalizations post EMS BUP among those who accepted EMS buprenorphine
Time frame: Within 30 days after EMS encounter
Adverse Events
The number of adverse events per participant after EMS-BUP initiation among all those who accepted EMS-BUP
Time frame: Within 30 days after EMS-BUP encounter
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