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

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Abuse
• Intervention / Treatment: 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, the investigators 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 Type: Observational
• Enrollment (Estimated): 362

Contacts and Locations

• Study Contact: Name: Jerry Cochran; Phone Number: 801-213-0654; Email: jerry.cochran@hsc.utah.edu
• Study Contact Backup: Name: Grace Humiston; Phone Number: 801-885-2221; Email: grace.humiston@hsc.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Recruiting
      • University Of Utah
      • Contact: Jerry Cochran; Phone Number: 801-213-0654; Email: jerry.cochran@hsc.utah.edu
      • Contact: Grace Humiston; Phone Number: 801-885-2221; Email: grace.humiston@hsc.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Focused: Number of patients receiving services.	Will be the aggregate number of individuals who received ED-initiated buprenorphine.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation and service quality: Satisfaction with projected service	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).	24 months.
Implementation and service quality: Patient satisfaction	Patient satisfaction will be assessed using the Patient Satisfaction Questionnaire Short Form (PSQ-18)	enrollment and 6 months post enrollment
Substance use diagnosis and treatment	Using the Government Performance and Results Act (GPRA) Outcome questions on substance use within the past 30 days, other substance use disorder diagnoses and treatment in the past 30 days, and mental health diagnoses.	enrollment and 6 months post enrollment
Social Connectedness	Social connectedness will be measured using the GPRA questions on mutual support group attendance in the last 30 days and relationship satisfaction and support.	enrollment and 6 months post enrollment
Living Conditions	Living conditions will be measured using the GPRA questions on residence within the past 30 days.	enrollment and 6 months post enrollment
Mental and Physical Health Problems and Treatment/Recovery	Mental and physical health problems and treatment/recovery will be measured using the GPRA questions on mental health symptoms and medical care received in the past 30 days and insurance status.	enrollment and 6 months post enrollment
Legal Status	Legal status will be measured using the GPRA questions on incarceration in the past 30 days, charges, trial, sentencing, parole, probation, and drug court status.	enrollment and 6 months post enrollment
Discharge status	Discharge status will be measured using the GRPA questions on substance use diagnosis and treatment in the past 30 days.	enrollment and 6 months post enrollment
Follow-up Status	Follow-up status will be measured using the GPRA questions on contact and follow-up status.	enrollment and 6 months post enrollment
Education, Employment, and Income	Education, employment, and income will be measured using the GPRA questions on education level, employment status, living expenses and income status.	enrollment and 6 months post enrollment

Collaborators and Investigators

• Sponsor: Jerry Cochran
• Collaborators: Castleview Hospital
• Investigators: Principal Investigator: Jerry Cochran, University Of Utah

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 158724

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No