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

NCT05706311 | Active Not Recruiting

• 2 other identifiers: CTN-01383UG1DA049444-04S2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Prescription Opioid Abuse; Opioid Abuse

Outcome Measures

Primary Outcomes (3)

• Stage 1: Development of the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool

  This outcome will be assessed using the System Usability Scale (SUS).

  24 months

• Stage 2: Improvement in patient opioid-related risks

  This outcome will be assessed using the Narcotic Score (NS).

  24 months

• Stage 3: ORRCDS sustainability within the system and pharmacy chain systems

  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.

  24 months

Study Arms (2)

Intervention Pharmacy Site

EXPERIMENTAL

Pharmacies randomized to the experimental arm will be exposed to the intervention condition. Patients at the intervention pharmacy identified as at elevated risk will receive confirmatory screening for opioid risk. Those with confirmed moderate risk will receive a brief motivational intervention for medication misuse and an offer of naloxone dispensation. 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.

Behavioral: Clinical Decision Support Tool (Moderate Risk); Behavioral: Clinical Decision Support Tool (High Risk)

Control Pharmacy Site

OTHER

Standard of Care is the treatment as usual condition, which follows federal and Ohio state pharmacy requirements for pharmacists where in patients filling prescriptions receive information and opt-in counseling. 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.

Other: Standard of Care

Interventions

Clinical Decision Support Tool (Moderate Risk) BEHAVIORAL

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

Intervention Pharmacy Site

Clinical Decision Support Tool (High Risk) BEHAVIORAL

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.

Intervention Pharmacy Site

Standard of Care OTHER

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.

Control Pharmacy Site

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None
• This study does not involve individual patients as randomization will occur among pharmacies.

Sponsors & Collaborators

• University of Utah: lead
• University of Cincinnati: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jerry Cochran, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a type-1 cluster 2-arm randomized trial. Randomization will take place at the pharmacy level and will be stratified by zip code level of poverty and pharmacy patient volume.

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 31, 2023
• Study Start: January 21, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)