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

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.

Conditions

• Opioid Abuse
• Prescription Opioid Abuse

Interventions

BEHAVIORAL

Clinical Decision Support Tool (Moderate Risk)

Moderate risk patients will get brief motivational intervention for medication misuse and an offer of naloxone dispensation.

BEHAVIORAL

Clinical Decision Support Tool (High Risk)

Those with high risk will receive a brief motivational intervention leading to warm handoff treatment linkage intervention to primary or specialty substance use care with an offer for naloxone dispensation.

OTHER

Standard of Care

Ohio State law requires pharmacist to not dispense an opioid supply \>90 days, with a specific prohibition on dispensations ≥14 days after prescriptions are issued. Pharmacists are also required to perform a universal prescription drug medication review before initial dispensation and offer brief counseling (e.g., unstandardized information about medication safety) for new/modified prescription therapies.

Sponsors & Collaborators

• University of Cincinnati

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• University of Utah

  lead OTHER

Principal Investigators

• Jerry Cochran, PhD · Associate Professor

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-21

Primary Completion

2026-05-15

Completion

2026-05-15

Countries

• United States

Study Locations