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

Opioid Abuse Clinical Trial

— BINDeR-TX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087991
• Other study ID #: 158724
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2023
• Source: University of Utah
• Contact: Jerry Cochran
• Phone: 801-213-0654
• Email: jerry.cochran[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 362
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Abuse
• Opioid-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Jerry Cochran

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Focused: Number of patients receiving services.	Will be the aggregate number of individuals who received ED-initiated buprenorphine.	24 months
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	Living Conditions	Living conditions will be measured using the GPRA questions on residence within the past 30 days.	enrollment and 6 months post enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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