Overdose Recovery and Care Access (ORCA) Qualitative Stakeholder Interviews and County-level Data

NCT06768814 | Recruiting DMC

• 2 other identifiers: STUDY00019871R33DA057600
• Study Type: interventional
• Target: 40,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder; Opioid Use

Keywords

opioid overdose; opioid poisoning; harm-reduction; sub-acute stabilization

Outcome Measures

Primary Outcomes (6)

• Repeat opioid overdose

  One of more opioid overdoses after enrollment

  1 year

• MOUD initiation

  Starting opioid use disorder treatment with buprenorphine, methadone or naltrexone

  1 year

• MOUD retention

  Having one or more additional doses prescribed, administered or dispensed of buprenorphine, methadone, or naltrexone

  1 year

• Emergency department utilization

  Having one or more all-cause emergency department admission

  1 year

• EMS utilization

  Having one or more emergency medical service encounters

  1 year

• Cost-effectiveness

  Analysis from the perspective of a public sector payer of the per unit cost of reduced opioid overdoses attributable to the diversion program

  1 year

Other Outcomes (3)

• Service utilization patterns

  1 year

• Staff observations

  1 year

• Continuous process improvement (CPI) partner observations

  1 year

Study Arms (2)

Intervention

OTHER

The sub-acute stabilization center will combine: 1) post-overdose medical and social support, 2) the offer of starting medications for opioid use disorder, and 3) harm reduction services and supplies.

Behavioral: Sub-acute stabilization

Comparison

NO INTERVENTION

Eligible Seattle EMS patients who opt not to go to the sub-acute stabilization center, and King County residents, outside of Seattle, who meet the same eligibility criteria.

Interventions

Sub-acute stabilization BEHAVIORAL

The sub-acute stabilization center (SASC) is 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 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Verbally consents to transfer of care to SASC.
• Awake and oriented to person and place, with no significant deficits in mental status or neurological function.
• Age \>=18
• Patent airway and effective respirations with adequate oxygenation.
• Stable heart rate and blood pressure, with no evidence of cardiac arrhythmias or other significant cardiovascular disfunction.
• 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
• No signs of head trauma:

You may not qualify if:

• \- People under 18 and who do not meet SASC admission criteria will be excluded.

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Downtown Emergency Service Center's Overdose Recovery and Care Access Centers

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Opiate Overdose; Harm Reduction

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drug Overdose; Prescription Drug Misuse; Drug Misuse; Behavior

Study Officials

• Caleb Banta-Green, PhD, MPH, MSW

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony S Floyd, PhD

CONTACT

206-616-7382; asfloyd@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor, School of Medicine, Psychiatry

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: December 15, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)