NCT06087991

Brief Summary

This study is a collaboration between the University of Utah and Castleview Hospital in Price, Utah. Buprenorphine is a medication approved by the FDA to treat Opioid Use Disorder (OUD). Castleview Hospital currently does not prescribe buprenorphine in the emergency department (ED) instead it refers patients to outside addiction treatment facilities. This is a service focused project which the University of Utah will provide mentoring and education to Castleview in implementing an in ED buprenorphine/naloxone distribution program along with referral to continued services. After the program has been implemented, the investigators will evaluate it using quantitative surveys of program participants and qualitative interviews of hospital staff and stakeholders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

October 11, 2023

Last Update Submit

June 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Focused: Number of patients receiving services.

    Will be the aggregate number of individuals who received ED-initiated buprenorphine.

    24 months

Secondary Outcomes (10)

  • Implementation and service quality: Satisfaction with projected service

    24 months.

  • Implementation and service quality: Patient satisfaction

    enrollment and 6 months post enrollment

  • Substance use diagnosis and treatment

    enrollment and 6 months post enrollment

  • Social Connectedness

    enrollment and 6 months post enrollment

  • Living Conditions

    enrollment and 6 months post enrollment

  • +5 more secondary outcomes

Study Arms (2)

Quantitative Interviews

Any Castleview patient who participates in this model will be emailed both the Patient Satisfaction Questionnaire Short Form (PSQ 18) and the Government Performance and Results Act surveys after hospital discharge, six months, and at discharge for buprenorphine.

Behavioral: Implementation of the BINDeR-Tx service model

Qualitative Interviews

Qualitative interviews among providers, stakeholders and community members associated with Castleview Hospital will be conducted after the model has been deployed. The qualitative interviews will come from The Consolidated Framework for Implementation Research (CFIR) which is a validated tool that was developed that was developed to evaluate implementation studies.

Behavioral: Implementation of the BINDeR-Tx service model

Interventions

ED-initiated buprenorphine, discharge with naloxone, and warm-hand off referral for continued treatment for individuals with OUD. This is considered standard treatment at the University of Utah ED. In order to extend these services to rural hospitals this study will be assisting Castleview Hospital to establish a similar program.

Qualitative InterviewsQuantitative Interviews

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

25 qualitative interviews of Castleview providers and stakeholders; 337 Castleview patient participants given buprenorphine and naloxone kits

You may qualify if:

  • For qualitative interviews with providers, administrators, stakeholders:
  • Must be affiliated with Castleview Hospital as a provider, administrator or stakeholder.
  • For the quantitative surveys:
  • Must be a Castleview Hospital patient who receives the BINDeR-Tx model.

You may not qualify if:

  • For qualitative interviews with providers, administrators, stakeholders:
  • Not familiar with the BINDeR-Tx model
  • No interaction with the BINDeR-Tx model
  • For the quantitative surveys:
  • Unable to speak and read English
  • Subject is unable to provide contact information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

  • Seliski N, Madsen T, Eley S, Colosimo J, Engar T, Gordon A, Barnett C, Humiston G, Morsillo T, Stolebarger L, Smid MC, Cochran G. Implementation of a rural emergency department-initiated buprenorphine program in the mountain west: a study protocol. Addict Sci Clin Pract. 2024 Sep 3;19(1):63. doi: 10.1186/s13722-024-00496-0.

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Jerry Cochran

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 18, 2023

Study Start

April 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

June 24, 2025

Record last verified: 2025-06

Locations