Clinical trial NCT05706311: Community Pharmacy-Based Prescription Drug Monitoring Program Opioid Risk Assessment Tool
Official title: Adaption and Implementation of a Community Pharmacy-Based Prescription Drug Monitoring Program Opioid Risk Assessment Tool (PharmTool)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Abuse
Prescription Opioid Abuse
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-01-31
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Stage 1: Development of the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool
timeFrame: 24 months
measure: Stage 2: Improvement in patient opioid-related risks
timeFrame: 24 months
measure: Stage 3: ORRCDS sustainability within the system and pharmacy chain systems
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Associate Professor
name: Jerry Cochran, PhD
role: PRINCIPAL_INVESTIGATOR
References: