BINDeR-TX: Buprenorphine Induction and Naloxone Distribution Program-Combined With Warm Hand-Off Referral to Continued Treatment

Sponsor
Jerry Cochran (Other)
Overall Status
Recruiting
CT.gov ID
NCT06087991
Collaborator
Castleview Hospital (Other)
362
1
18
20.1

Study Details

Study Description

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, we will evaluate it using quantitative surveys of program participants and qualitative interviews of hospital staff and stakeholders.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Implementation of the BINDeR-Tx service model

Detailed Description

Among health care environments, ED often are the front lines of care for those with OUD or who experience opioid overdose.

The University of Utah Hospital ED has the Bridge Program which provides buprenorphine and naloxone with warm-hand off referral for continued treatment to people presenting with OUD. In order to extend the services offered by the Bridge Program to rural hospitals, we will be providing mentoring and education to Castleview Hospital in establishing a similar program. Castleview Hospital is the only acute care hospital that serves Carbon and Emery counties, which outside of the Salt Lake City metro area have the highest opioid overdose rates in the State of Utah.

This project will utilize both quantitative and qualitative measures to evaluate the impact of this program on patients, hospital staff, and community members.

Study Design

Study Type:
Observational
Anticipated Enrollment :
362 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Buprenorphine Induction and Naloxone Distribution Program-Combined With Warm Hand-Off Referral to Continued Treatment
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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
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 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
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.

Outcome Measures

Primary Outcome Measures

  1. Patient Focused: Number of patients receiving services. [24 months]

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

Secondary Outcome Measures

  1. Implementation and service quality: Satisfaction with projected service [24 months.]

    Qualitative interviews including clinicians, hospital staff, and community members associated with Castleview Hospital will be the investigators using the Consolidated Framework for Implementation Research (CFIR).

  2. Government Performance and Result Act (GPRA) Outcomes [24 months]

    The GPRA is a validated tool that includes outcomes related to substance use, criminal activity, mental and physical health, family and living conditions, education/employment status, and social connectedness. This is taken after hospital discharge, at 6-months, and at discharge for buprenorphine.

  3. Implementation and service quality: Patient satisfaction [24 months]

    Patient satisfaction will be assessed using the Patient Satisfaction Questionnaire Short Form (PSQ-18)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
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.
Exclusion Criteria:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Utah Salt Lake City Utah United States 84108

Sponsors and Collaborators

  • Jerry Cochran
  • Castleview Hospital

Investigators

  • Principal Investigator: Jerry Cochran, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jerry Cochran, Associate Professor, University of Utah
ClinicalTrials.gov Identifier:
NCT06087991
Other Study ID Numbers:
  • 158724
First Posted:
Oct 18, 2023
Last Update Posted:
Oct 18, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2023