Implementing pragmatic clinical trials in rural settings: Challenges, solutions and lessons learned

Area of Science:

• Implementation Science
• Pragmatic Clinical Trials
• Rural Health

Background:

• Rural communities experience high rates of opioid use disorder (OUD) and overdose mortality.
• Limited access to medications for opioid use disorder (MOUD) and underrepresentation in research persist in rural areas.
• Structural barriers like provider shortages, transportation issues, and stigma hinder evidence-based treatment.

Purpose of the Study:

• To describe the implementation of two rural pragmatic trials (CTN-0102 and CTN-0102XR).
• To identify challenges encountered during study implementation in rural settings.
• To present lessons learned by applying implementation science frameworks (CFIR, ERIC).

Main Methods:

• Conducted two pragmatic trials in 13 rural primary care clinics across 10 states.
• CTN-0102: Telemedicine (TM) feasibility study connecting patients to MOUD providers.
• CTN-0102XR: Pilot randomized trial comparing extended-release buprenorphine to sublingual buprenorphine-naloxone.

Main Results:

• Demonstrated feasibility of integrating MOUD into primary care using pragmatic designs.
• Key challenges included limited research capacity, staff stigma, communication barriers, and variable digital access.
• Successful solutions involved local champions, tailored workflows, simplified technology, and strong communication.

Conclusions:

• Pragmatic trials in rural settings require early contextual assessment and stakeholder engagement.
• Adaptable protocols and robust implementation support are crucial for success and sustainability.
• Continued focus on rural site inclusion and capacity building is needed for equitable OUD treatment access.