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

Sponsor

University of Utah (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05706311

Collaborator

University of Cincinnati (Other), National Institute on Drug Abuse (NIDA) (NIH)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Abuse Prescription Opioid Abuse	Behavioral: Clinical Decision Support Tool (Moderate Risk) Behavioral: Clinical Decision Support Tool (High Risk) Other: Standard of Care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2024

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Mar 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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: 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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati	Cincinnati	Ohio	United States	45267
2	University of Utah	Salt Lake City	Utah	United States	84108

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jerry Cochran, PhD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jerry Cochran, Associate Professor, University of Utah

ClinicalTrials.gov Identifier:

NCT05706311

Other Study ID Numbers:

CTN-0138
3UG1DA049444-04S2

First Posted:

Jan 31, 2023

Last Update Posted:

Jan 31, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Opioid-Related Disorders

Study Results

No Results Posted as of Jan 31, 2023