CTN-0138: adaptation, implementation, and cluster randomized trial of a Community Pharmacy-Based Prescription Drug...

Area of Science:

• Pharmacy Practice
• Public Health
• Clinical Informatics

Background:

• Community pharmacies face scrutiny over opioid dispensing and patient intervention.
• Current Prescription Drug Monitoring Programs (PDMP) lack actionable decision support for pharmacists.
• A gap exists in tools to effectively manage patients with moderate- and high-risk opioid use in community settings.

Purpose of the Study:

• To develop and implement the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool within a PDMP platform.
• To assess the ORRCDS tool's effectiveness in reducing patient opioid risk.
• To evaluate the sustainability and dissemination potential of the ORRCDS tool in community pharmacy.

Main Methods:

• Implementation of the ORRCDS tool in a large pharmacy chain using the GUIDES framework.
• A type-1 implementation mixed methods study with a 2-arm parallel group clustered randomized design, enrolling approximately 6,600 patients across 80 pharmacies.
• Qualitative interviews using the Consolidated Framework for Implementation Research (CFIR) with pharmacists, pharmacy leaders, and PDMP leaders to assess sustainability.

Main Results:

• The study aims to demonstrate the ORRCDS tool's ability to reduce opioid risk in patients.
• Anticipated power to detect a 5% or greater difference in responder rates between intervention and control arms.
• Data from qualitative interviews will inform long-term adoption and sustainability strategies.

Conclusions:

• A novel PDMP-integrated tool, ORRCDS, is being implemented to address moderate- and high-risk opioid use in community pharmacies.
• The ORRCDS tool provides enhanced screening and guidance for pharmacy staff to manage at-risk patients.
• This research is expected to advance patient health protection and contribute to addressing the ongoing opioid epidemic.