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

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder; Opioid Use
• Intervention / Treatment: Behavioral: Sub-acute stabilization

Detailed Description

1. Clinical Intervention

   • We will be conducting a quasi-experimental study of a new sub-acute stabilization center (SASC) for those at high risk or who have had an opioid overdose to which Seattle Fire/EMS refer. All eligible people at risk or post OD who encounter Seattle Fire/EMS will potentially be offered the intervention, and those interested and transported will be considered study participants, there is no study assignment (anticipated n=5,495).
   • Comparison groups will be identified from secondary EMS records data for Seattle (anticipated n=7,223) and the remainder of King County, WA (anticipated n=11,550).
   • People 18 and older who EMS encounter who have had or are at high risk for any opioid overdose and meet clinical inclusion criteria.

   • SASC services will be provided by Downtown Emergency Service Center's Overdose Recovery and Care Access Centers:

     • 515 Third Avenue, Seattle, WA 98104
     • 517 Third Avenue, Seattle, WA 98104
     • 1600 South Lane Street Seattle, WA 98144

2. Implementation research interviews with professional stakeholders

   • We will be conducting repeated cross-sectional interviews with professional stakeholders about the implementation of the SASC and CPI activities.
   • Participants will be 18 or older and include people such as: CPI meeting attendees, EMS personnel, and SASC staff (n=60).
   • It is anticipated that stakeholder interviews will be conducted virtually via video conferencing with study team members.

3. Implementation research surveys with people with lived experience of drug use

   • We will be utilizing a combination of data sources. Initially in-person interview data from the 1R01DA059011-01 study (Van Draanen, PI) will be utilized for analyses.
   • Participants from the Van Draanen study will be 18 or older who have have survived a non-fatal opioid overdose and had an emergency medical service interaction or intervention (n=80).
   • If needed, we will also, subsequently conduct repeated cross-sectional surveys with people with lived experience of drug use about their experiences and perceptions of the SASC. Final procedures will be determined in collaboration with our community partner the Lived Expertise Advisory Board.

• Study Type: Interventional
• Enrollment (Estimated): 40000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anthony S Floyd, PhD; Phone Number: 206-616-7382; Email: asfloyd@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Downtown Emergency Service Center's Overdose Recovery and Care Access Centers
      • Contact: Daniel Malone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 or pupils that are slow to react to light.
8. No signs of other traumatic injury or medical needs requiring immediate treatment.
9. No signs of respiratory infection. Screen for COVID-19. See COVID-19 Screening protocol.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; 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; 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.
No Intervention: Comparison; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Service utilization patterns	Changes in the way services or opioid-related emergencies are provided and changes to cascade of care changes over time (descriptive).	1 year
Staff observations	How care opioid-related care is viewed by SASC staff members (descriptive).	1 year
Continuous process improvement (CPI) partner observations	How care opioid-related care is viewed by CPI partners and participants (descriptive).	1 year

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Caleb Banta-Green, PhD, MPH, MSW, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: opioid overdose; opioid poisoning; harm-reduction; sub-acute stabilization
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Drug Misuse; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drug Overdose; Prescription Drug Misuse; Behavior; Opiate Overdose; Opioid-Related Disorders; Harm Reduction
• Other Study ID Numbers: STUDY00019871; R33DA057600 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No