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

NCT ID: NCT05706311

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2026-07-30

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.

Conditions

Opioid Abuse; Prescription Opioid Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Pharmacy Site

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.

Group Type: EXPERIMENTAL

Clinical Decision Support Tool (Moderate Risk)

Intervention Type: BEHAVIORAL

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

Clinical Decision Support Tool (High Risk)

Intervention Type: 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.

Control Pharmacy Site

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.

Group Type: OTHER

Standard of Care

Intervention Type: 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.

Interventions

Clinical Decision Support Tool (Moderate Risk)

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cincinnati

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Jerry Cochran

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerry Cochran, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

University of Cincinnati

Cincinnati, Ohio, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

3UG1DA049444-04S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CTN-0138

Identifier Type: -

Identifier Source: org_study_id