Community Pharmacy-Based Prescription Drug Monitoring Program Opioid Risk Assessment Tool

Not Applicable

Recruiting

• Conditions: Opioid Abuse; Prescription Opioid Abuse

• Registration Number: NCT05706311
• Lead Sponsor: University of Utah

Brief Summary

This goal of this observational study is to develop and test the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool. The tool will be an opioid medication risk screener and decision support platform that will be used by pharmacists upon dispensing prescription opioid medication. Once the Opioid Risk Reduction has been developed, we will examine the impact of the ORRCDS within two divisions of a large chain retail pharmacy. Pharmacies will be randomized to using the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool or standard of care opioid dispensation. We hypothesize that patients at pharmacies randomized to the ORRCDS tool will be more likely to reduce their risk status to low or moderate compared to the patients at standard of care pharmacies.

Detailed Description

In our previous research, patients have reported a willingness to answer questions and discuss opioid medication use with pharmacists in these settings. Therefore, community pharmacy settings are an underused resource with great promise for screening and engaging patients to reduce opioid medication misuse. Currently, prescription drug monitoring programs (PDMP) are the most available tool to pharmacists for monitoring opioid use among patients. As a result, PDMP users must rely on their "best judgment" in clinical decision-making and often provide patient care and referrals with a limited evidence base. The question of highest importance in the field of prescription medication misuse is: How can PDMP information/output be most usefully utilized for patient intervention within an evidence-based opioid risk reduction clinical decision support (ORRCDS) tool.

This study will develop and test the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool and examining facilitators and barriers to sustainability and broader dissemination. The study is organized into 3 aims:

Aim 1: ORRCDS Tool development which will include a universal opioid medication risk screener and decision support platform.

Aim 2: Once the ORRCDS has been developed, we will conduct a type-1 cluster 2-arm randomized trial to examine the impact of the ORRCDS tool within two divisions of a large chain retail pharmacy. We hypothesize that patients with moderate or high opioid risk will be more likely to reduce risk status to low or moderate following ORRCDS implementation compared to standard care.

Aim 3: Following the completion of the cluster randomized trial, qualitative interviews will be conducted with pharmacists and leaders from a large chain retail pharmacy and PDMP vendor about the potential barriers and facilitators to the sustainability (continued use at the stores in this project) and broader dissemination (implementation at other stores outside of those in this project) of the ORRCDS.

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-31
• Study Start: 2025-01-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22
• Primary Completion: 2026-01-16
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• A large chain retail pharmacy chain in the Cincinnati or Columbus, Ohio area

Exclusion Criteria

• None

This study does not involve individual patients as randomization will occur among pharmacies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stage 1: Development of the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool	24 months	This outcome will be assessed using the System Usability Scale (SUS).
Stage 2: Improvement in patient opioid-related risks	24 months	This outcome will be assessed using the Narcotic Score (NS).
Stage 3: ORRCDS sustainability within the system and pharmacy chain systems	24 months	Using the Consolidated Framework for Implementation Research the investigators will interview staff from the PDMP vendor and large chain retail pharmacy to assesses the barriers of tool sustainability.

Trial Locations

Locations (2)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States