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

NCT ID: NCT06768814

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2029-05-31

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.

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.

Conditions

Opioid Use Disorder; Opioid Use

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Sub-acute stabilization

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Caleb Banta-Green

Research Professor, School of Medicine, Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caleb Banta-Green, PhD, MPH, MSW

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anthony S Floyd, PhD

Role: CONTACT

asfloyd@uw.edu

206-616-7382

Facility Contacts

Daniel Malone

Role: primary

Other Identifiers

R33DA057600

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00019871

Identifier Type: -

Identifier Source: org_study_id