Study component | Outcomes | Population | |
---|---|---|---|
Component 1—Formative evaluation and IF | Implementation outcomes | Stakeholder acceptability over time (interviews, focus groups) Stakeholder readiness/preparedness over time (ORCA, change rulers) | Community and ED key informants |
Component 2—Evaluation of clinical protocol | Primary clinical outcome | Received ED-initiated BUP (proportion) (EMR abstraction) | ED patients determined to be eligible for and willing to receive ED-initiated BUP |
Secondary outcomes—Process measures and additional proportions of interest | Opioid screen completed | ED patients (adult) | |
Opioid Screen positive | Screen completed | ||
ED-initiated BUP eligibility assessment completed | Opioid Screen positive | ||
ED-initiated BUP eligible | Opioid Screen positive | ||
ED-initiated BUP eligible and willing | ED-initiated BUP eligible | ||
Received a facilitated referral for treatment | ED-initiated BUP received | ||
Received a facilitated referral for treatment | Eligible and willing for ED-initiated BUP, but not received | ||
Component 3—Patient-participant outcomes | Main secondary outcome | Engaged in formal addiction treatment 30 days after the index ED visit (proportion) (patient self-report with clinic confirmation) | Enrolled patient-participants who received ED-initiated BUP (secondarily, BUP non-receivers) |
Secondary outcomes—Patient treatment | Value and change from baseline for the following: Substance use (self-report via TLFB, UDS) Overdose events (self-report) Healthcare utilization (self-report Heath Services Utilization Form) Quality of life (EQ5D) Treatment satisfaction and acceptability (self-report) Initial contact with medication provider (9-day) | Enrolled patient-participants who received ED-initiated BUP (secondarily, BUP non-receivers) |