NCT06768814 Overdose Recovery and Care Access (ORCA) Qualitative Stakeholder Interviews and County-level Data
| NCT ID | NCT06768814 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40,000 participants |
| Start Date | 2024-12-15 |
| Primary Completion | 2028-05-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The study is a quasi-experimental investigation of a sub-acute stabilization center (SASC) for people who have had or are at risk for having an opioid overdose and have an encounter with Seattle Fire Department emergency medical services (EMS) in Seattle, WA. Those transported to the SASC are the intervention participants and two comparison groups will be utilized: eligible Seattle EMS patients who opt not to go to the SASC and King County residents, outside of Seattle, who meet the same eligibility criteria. A comparative interrupted time series analysis is planned to study the main effectiveness outcomes. Seattle Fire EMS will assess, refer, and arrange transport for participants to the SASC. The SASC will offer an array of services including post-overdose monitoring, utilization of buprenorphine and methadone for the treatment opioid use disorder and opioid withdrawal, linkage to ongoing care for OUD, and provision of harm reduction services and supplies. The length of stay in the SASC will be limited to less than 24 hours. A continuous process improvement (CPI) approach will monitor and refine the intervention. Characterization of the interventions will be based upon analysis of service utilization patterns over time along with interviews and surveys with stakeholders.
Eligibility Criteria
Inclusion Criteria: 1. Verbally consents to transfer of care to SASC. 2. Awake and oriented to person and place, with no significant deficits in mental status or neurological function. 3. Age \>=18 4. Patent airway and effective respirations with adequate oxygenation. 5. Stable heart rate and blood pressure, with no evidence of cardiac arrhythmias or other significant cardiovascular disfunction. 6. Vitals: * Heart rate: 45-130 * Blood pressure: systolic 95-190, diastolic 50-120 * Respiratory rate: 10-24 * SpO2: \>92 on room air or supplemental O2 via nasal cannula. * SpO2 \<92% with supplemental O2 requires ED transfer. * EtCO2: \<50 * Temperature: 95.5-100.3 F * Blood glucose (if indicated): 60-300 7. No signs of head trauma: * Dizziness or loss of balance * Blurred vision or double vision * Sensitivity to light or noise * Seizures or convulsions * Weakness or numbness in the arms or legs * Persistent or worsening headache * CSF or blood leaking from the nose or ears * Unequal pupils