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Opioid Risk Assessment Tool for Opioid Use Disorder (PharmTool Trial)

N/A

Waitlist Available

Led By Jerry Cochran, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess the impact of a new opioid medication risk screener and decision support platform to reduce risk status in two pharmacy divisions.

Who is the study for?

This trial is for pharmacies in the Cincinnati or Columbus, Ohio areas. It's not for individual patients; instead, entire pharmacies will participate to see if a new tool helps manage opioid risks better than usual care.

What is being tested?

The study tests an Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool against standard care in pharmacies. Pharmacies are randomly chosen to use either the ORRCDS tool or continue with their regular process when dispensing opioids.

What are the potential side effects?

Since this trial involves the use of a decision support tool rather than direct patient treatment, there are no medical side effects associated with its implementation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Stage 2: Improvement in patient opioid-related risks

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention Pharmacy SiteExperimental Treatment2 Interventions

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 II: Control Pharmacy SiteExperimental Treatment1 Intervention

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.

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