Integrating Addiction and Infectious Diseases Services Into Primary Care in Rural Settings
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Organizational Readiness and Staff Attitudes towards integration of OUD, HIV, HCV services into primary care clinics
研究概览
简要总结
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.
详细描述
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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Federally Qualified Health Centers (FQHCs) and Look-Alike FQHC Primary Care Clinics in West Virginia providing adult care
排除标准
- •Clinics (private or specialty) or any clinics not in West Virginia
研究组 & 干预措施
Intervention - Nominal Group Technique, Training, Coaching
Each group of clinics will receive the same intervention in a step-wedge design, starting every 6-months.
干预措施: NIATx Coaching (Behavioral)
结局指标
主要结局
Organizational Readiness and Staff Attitudes towards integration of OUD, HIV, HCV services into primary care clinics
时间窗: Every 6 months for 24 months
Staff survey results on organizational capacity, readiness to change, organizational functioning and social dominance orientation, and resistance to change.
Number of patients screened for HIV
时间窗: 18 months
Lab ordered and result for HIV test entered in EHR
Number of patients prescribed PrEP
时间窗: 18 months
For those with a negative HIV result, prescription medication for PrEP; medication type; prescription dates; lab orders
Number of patients screened for opioid use disorder (OUD)
时间窗: 18 months
Screening result for opioid use disorder documented in electronic health record (EHR)
Number of patients initiated on medications for OUD
时间窗: 18 months
Prescription medication for OUD; prescription dates, medication type
Number of patients screened for Hepatitis C (HCV)
时间窗: 18 months
Lab result ordered for HCV antibody / reflex polymerase chain reaction (PCR), result entered in EHR
Integration of services
时间窗: 24 months
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 initiated on antiretroviral medication (ART) for HIV
时间窗: 18 months
For those with a positive HIV test result, prescription medication for HIV; prescription dates
Number of patients initiated on medication for HCV
时间窗: 18 months
For those with a positive HCV PCR test, documented in EHR prescription medication for HCV; prescription dates; fibrosis score
次要结局
- Number of patients with sustained viral response for HCV(18 months)
- Quality Health Indicator (QHI) score for Primary Care screening variables(18 months)
- Number of patients on PrEP to prevent HIV(12 months)
- Number of patients retained on medication for OUD for at least 6 months(6 months)
- Number of patients retained on medication (ART) for HIV(12 months)
- Number of patients with Viral Suppression for HIV(12 months)