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NCT Number: NCT05706311

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

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.

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Key information

Conditions

Opioid Abuse Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Prescription Opioid Abuse Substance-Related Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati, Cincinnati, Ohio, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical Decision Support Tool (Moderate Risk)

Behavioral

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

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.

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.

Primary outcomes

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

    Time frame: 24 months

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

  2. Stage 2: Improvement in patient opioid-related risks

    Time frame: 24 months

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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Cincinnati

Registry information

Official study title

Adaption and Implementation of a Community Pharmacy-Based Prescription Drug Monitoring Program Opioid Risk Assessment Tool (PharmTool)

Acronym: PharmTool

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 31, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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