Buprenorphine Integration Research and Community Health (BIRCH)
Primary Purpose
Opioid Use Disorder, HIV Infections, Hepatitis C
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NIATx Coaching
Sponsored by
About this trial
This is an interventional health services research trial for Opioid Use Disorder focused on measuring Implementation Science, HIV, Medication for Opioid Use Disorder, PrEP, Hepatitis C, Nominal Group Technique
Eligibility Criteria
Inclusion Criteria: - Federally Qualified Health Centers (FQHCs) and Look-Alike FQHC Primary Care Clinics in West Virginia providing adult care Exclusion Criteria: Clinics (private or specialty) or any clinics not in West Virginia
Sites / Locations
- West Virginia UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention - Nominal Group Technique, Training, Coaching
Arm Description
Each group of clinics will receive the same intervention in a step-wedge design, starting every 6-months.
Outcomes
Primary Outcome Measures
Organizational Readiness and Staff Attitudes towards integration of OUD, HIV, HCV services into primary care clinics
Staff survey results on organizational capacity, readiness to change, organizational functioning and social dominance orientation, and resistance to change.
Integration of services
Adoption of screening and implementation of best evidence-based practices. Quality health indicators (QHIs) for primary care - OUD, HIV & HCV documented in electronic health record data.
Number of patients screened for opioid use disorder (OUD)
Screening result for opioid use disorder documented in electronic health record (EHR)
Number of patients initiated on medications for OUD
Prescription medication for OUD; prescription dates, medication type
Number of patients screened for HIV
Lab ordered and result for HIV test entered in EHR
Number of patients initiated on antiretroviral medication (ART) for HIV
For those with a positive HIV test result, prescription medication for HIV; prescription dates
Number of patients screened for Hepatitis C (HCV)
Lab result ordered for HCV antibody / reflex polymerase chain reaction (PCR), result entered in EHR
Number of patients initiated on medication for HCV
For those with a positive HCV PCR test, documented in EHR prescription medication for HCV; prescription dates; fibrosis score
Number of patients prescribed PrEP
For those with a negative HIV result, prescription medication for PrEP; medication type; prescription dates; lab orders
Secondary Outcome Measures
Number of patients with sustained viral response for HCV
For those with HCV medication prescription; Viral load results in EHR after recommended treatment
Number of patients retained on medication for OUD for at least 6 months
For those with prescription for medication for OUD; documentation in EHR of repeated prescription orders
Number of patients retained on medication (ART) for HIV
For those with new prescription for medication for HIV; documentation in EHR of repeated prescriptions up to 6 and 12 months
Number of patients with Viral Suppression for HIV
For those with new HIV diagnosis; documentation in EHR of viral suppression defined as HIV RNA <200 copies/µl, at 6 and 12 months after prescription
Number of patients on PrEP to prevent HIV
Documentation of negative HIV labs in EHR every 3 months
Quality Health Indicator (QHI) score for Primary Care screening variables
QHI-PC score based on documentation of screening (limited age/sex) for hypertension, diabetes, hyperlipidemia, HIV, HCV, hepatitis B (HBV), syphilis, cervical cancer, breast cancers, prostate cancer, herpes simplex virus (HSV) serology, latent tuberculosis (TB), colorectal cancer, depression, chlamydia, gonorrhea.
Full Information
NCT ID
NCT05668780
First Posted
December 19, 2022
Last Updated
March 1, 2023
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA), West Virginia University
1. Study Identification
Unique Protocol Identification Number
NCT05668780
Brief Title
Buprenorphine Integration Research and Community Health
Acronym
BIRCH
Official Title
Integrating Addiction and Infectious Diseases Services Into Primary Care in Rural Settings
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA), West Virginia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this clinical trial is to evaluate an intervention strategy in introducing screen/evaluate/treat (SET) procedures for HIV/ hepatitis C/ and Opioid Use Disorder in Primary Care Clinics in West Virginia.
The main questions it aims to answer are:
What are the barriers and facilitators to integrating evidence based practices for screening and treatment of HIV, hepatitis C, and Opioid Use Disorder into primary care clinics in West Virginia?
To assess the extent to which our SET processes are achieved through enhanced EHR tools, NIATx (formerly known as Network for the Improvement of Addiction Treatment) facilitation and Extension for Community Healthcare Outcomes (ECHO)-supported collaborative learning?
Does implementing these services improve primary and secondary health outcomes for patients? Primary Care Clinics will participate in training and process improvement coaching to integrate these services. Using a step-wise design, 20 Primary Care Clinics will undergo the training and coaching in four groups of five clinics.
Detailed Description
To integrate HIV/HCV/ OUD services into Primary Care Clinics (PCC), the investigators will introduce screen/evaluate/treat (SET) procedures for HIV/hepatitis C (HCV)/ Opioid Use Disorder (OUD) in PCCs in rural WV where ECHO and WV Hepatitis Academic Mentoring Partnership (WVHAMP) will support clinical skills for Primary Care Provider (PCPs) and where NIATx process improvement tools will be used to guide adoption and scale-up of SET procedures to achieve integration. Using a step-wedge design with 20 PCCs, the investigators will conduct a Type 3 Hybrid implementation trial and examine the extent to which our SET processes are achieved through enhanced electronic health record (EHR) tools, NIATx facilitation and ECHO and WVHAMP collaborative learning. Implementation outcomes include adoption of screening and treating with three distinct but linked evidence based practices (EBPs) for OUD, HIV and HCV in PCCs. Effectiveness outcomes will include quality health indicators (QHIs) for primary care, HIV, HCV and OUD.
This project is separated into two Phases. Phase 1 includes Nominal Group Technique focus groups and anonymous staff surveys at the 20 PCCs to identify barriers and facilitators to integrating these evidence based practices. Phase 2 is an evaluation of deidentified reports from the PCCs Electronic Health Records. In Phase 2, randomized sites will start NIATx activities, including a series of rapid-cycle Plan-Do-Study-Act (PDSA) activities. The first 6 months will include intensive coaching from a certified NIATx coach and enhanced by support from ECHO & the WVHAMP to teach subspecialty clinical expertise. During an 18-month follow-up, the investigators will assess the sustainability of these practice changes. Effectiveness outcomes will include a set of nationally recommended quality health indicators (QHIs) to measure quality care. This project is a collaboration between Yale University, West Virginia University (WVU), and the West Virginia Primary Care Association.
Aim 1 (Phase 1):
Identify the barriers and facilitators for a diverse group of PCCs throughout WV, a mostly rural state that is profoundly impacted by OUD-associated HIV/HCV outbreaks, focusing on screening for and prescribing evidence-based treatment [medication for opioid use disorder (MOUD), Treatment as Prevention (TasP), pre-exposure prophylaxis (PrEP), and curative hepatitis C (HCV) treatment] for OUD, HIV and HCV.
Aim 2 (Phase 2):
Using a step-wedge design with 20 PCCs, the investigators will conduct a Type 3 hybrid implementation trial using the Integrated Promoting Action on Research Implementation in Health Services (iPARiHS) framework to assess the extent to which our SET processes are achieved through enhanced EHR tools, NIATx facilitation and ECHO-supported collaborative learning. Implementation outcomes include adoption of screening and implementation of three distinct but linked EBPs for OUD, HIV and HCV in PCCs. Effectiveness outcomes will include quality health indicators (QHIs) for primary care, HIV, HCV and OUD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, HIV Infections, Hepatitis C
Keywords
Implementation Science, HIV, Medication for Opioid Use Disorder, PrEP, Hepatitis C, Nominal Group Technique
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Using a step-wedge design with 20 PCCs, the investigators will conduct a Type 3 Hybrid implementation trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention - Nominal Group Technique, Training, Coaching
Arm Type
Experimental
Arm Description
Each group of clinics will receive the same intervention in a step-wedge design, starting every 6-months.
Intervention Type
Behavioral
Intervention Name(s)
NIATx Coaching
Intervention Description
The intervention will consist of:
a Nominal Group Technique session to identify priorities in integrating HIV/HCV/MOUD
rapid cycle improvement coaching sessions from a NIATx coach, using data dashboards and screening alerts to improve identification and treatment for HIV/HCV/OUD
training for primary care providers
Primary Outcome Measure Information:
Title
Organizational Readiness and Staff Attitudes towards integration of OUD, HIV, HCV services into primary care clinics
Description
Staff survey results on organizational capacity, readiness to change, organizational functioning and social dominance orientation, and resistance to change.
Time Frame
Every 6 months for 24 months
Title
Integration of services
Description
Adoption of screening and implementation of best evidence-based practices. Quality health indicators (QHIs) for primary care - OUD, HIV & HCV documented in electronic health record data.
Time Frame
24 months
Title
Number of patients screened for opioid use disorder (OUD)
Description
Screening result for opioid use disorder documented in electronic health record (EHR)
Time Frame
18 months
Title
Number of patients initiated on medications for OUD
Description
Prescription medication for OUD; prescription dates, medication type
Time Frame
18 months
Title
Number of patients screened for HIV
Description
Lab ordered and result for HIV test entered in EHR
Time Frame
18 months
Title
Number of patients initiated on antiretroviral medication (ART) for HIV
Description
For those with a positive HIV test result, prescription medication for HIV; prescription dates
Time Frame
18 months
Title
Number of patients screened for Hepatitis C (HCV)
Description
Lab result ordered for HCV antibody / reflex polymerase chain reaction (PCR), result entered in EHR
Time Frame
18 months
Title
Number of patients initiated on medication for HCV
Description
For those with a positive HCV PCR test, documented in EHR prescription medication for HCV; prescription dates; fibrosis score
Time Frame
18 months
Title
Number of patients prescribed PrEP
Description
For those with a negative HIV result, prescription medication for PrEP; medication type; prescription dates; lab orders
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Number of patients with sustained viral response for HCV
Description
For those with HCV medication prescription; Viral load results in EHR after recommended treatment
Time Frame
18 months
Title
Number of patients retained on medication for OUD for at least 6 months
Description
For those with prescription for medication for OUD; documentation in EHR of repeated prescription orders
Time Frame
6 months
Title
Number of patients retained on medication (ART) for HIV
Description
For those with new prescription for medication for HIV; documentation in EHR of repeated prescriptions up to 6 and 12 months
Time Frame
12 months
Title
Number of patients with Viral Suppression for HIV
Description
For those with new HIV diagnosis; documentation in EHR of viral suppression defined as HIV RNA <200 copies/µl, at 6 and 12 months after prescription
Time Frame
12 months
Title
Number of patients on PrEP to prevent HIV
Description
Documentation of negative HIV labs in EHR every 3 months
Time Frame
12 months
Title
Quality Health Indicator (QHI) score for Primary Care screening variables
Description
QHI-PC score based on documentation of screening (limited age/sex) for hypertension, diabetes, hyperlipidemia, HIV, HCV, hepatitis B (HBV), syphilis, cervical cancer, breast cancers, prostate cancer, herpes simplex virus (HSV) serology, latent tuberculosis (TB), colorectal cancer, depression, chlamydia, gonorrhea.
Time Frame
18 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Federally Qualified Health Centers (FQHCs) and Look-Alike FQHC Primary Care Clinics in West Virginia providing adult care
Exclusion Criteria:
Clinics (private or specialty) or any clinics not in West Virginia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adrienne Marable
Phone
203-737-3393
Email
gcat5@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick L Altice, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Natalie Kil, MPH
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Hutter-Thomas, PhD
Phone
304-288-8483
Email
jstephanie.hutterthomas@hsc.wvu.edu
First Name & Middle Initial & Last Name & Degree
Judith Feinberg, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Buprenorphine Integration Research and Community Health
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