An Evaluation of the Impact of Pharmacist Personalized Medication Reviews With and Without a Discussion of Pharmacogenomic Results in an Employee Health Program.

NCT06660264 | Enrolling By Invitation

• 1 other identifier: STUDY23050142
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective randomized clinical trial is to learn if a pharmacist-provided personalized medication review (PMR) that discusses pharmacogenomic test results will improve medication outcomes. The primary aim is to identify patients within the Pitt/UPMC employee health programs who are most likely to benefit from PGx testing based on prescription history. The second aim is to determine the effect of the pharmacist-provided PMR including PGx test results. Participants 18 years of age and older who have undergone PGx testing through a independent biobanking study (Pitt+Me Discovery) will be randomly assigned to receive PMR with a discussion of PGx test results or PMR without PGx results. Those who receive PMR only will receive PGx results one year after their PMR. Researchers will compare the groups to see if a pharmacist-provided PMR using PGx test results will lead to better medication outcomes and lower medical costs.

Conditions

Pharmacogenetics; Pharmacogenomic Drug Interaction

Keywords

Precision Medicine; Medication Review; PGx; Pharmacist; Pharmacogenomics; Employee health

Outcome Measures

Primary Outcomes (1)

• Change in Total Per Member Per Month (PMPM) Healthcare Costs

  Change in participant total per member/per month (PMPM) healthcare costs using healthplan claims data from 12 months prior to the pharmacist Personalized Medication Review (PMR) visit to 12 months after the PMR visit.

  From 12 Months prior to PMR visit and from the PMR visit to 12 Months after the PMR visit

Secondary Outcomes (9)

• Change in frequency of CPIC/FDA guideline concordant prescribing

  Baseline, 12 Months after PMR visit

• Change in healthcare utilization

  From 12 Months prior to PMR visit and from the PMR visit to 12 Months after the PMR visit.

• Number of adverse events as assessed using the Patient-Reported Outcome Measure, Inquiry into Side-Effects (PROMISE) survey

  6 Months after PMR visit

• Change in Medication Access and Adherence Tool (MAAT) Score

  Baseline, 6 Months after PMR

• Health-systems Alliance for Integrated Medication Management (HAIMM) Score after Personalized Medication Review

  After the PMR visit (up to 14 days after)

Study Arms (2)

Immediate Return of Pharmacogenomic Results

OTHER

Participants will be randomized to immediate versus delayed return of pharmacogenomic results obtained from testing conducted by an independent biobanking study (Pitt+Me Discovery). Participants in the immediate group will receive a pharmacist Personalized Medication Review with PGx results.

Other: Pharmacist Personalized Medication Review (PMR); Other: Discussion of Pharmacogenomic results during the PMR

Delayed Return of Pharmacogenomic Results

OTHER

Participants will be randomized to immediate versus delayed return of pharmacogenomic results obtained from testing conducted by an independent biobanking study. Participants in the delayed group with receive a pharmacist Personalized Medication Review without PGx results. The delayed group will receive results from the independent biobanking study (Pitt+Me Discovery) at 12 months after the Personalized Medication Review.

Other: Pharmacist Personalized Medication Review (PMR)

Interventions

Pharmacist Personalized Medication Review (PMR) OTHER

Pharmacist-provided review of current medications and assessment of potential medication related problems.

Delayed Return of Pharmacogenomic Results; Immediate Return of Pharmacogenomic Results

Discussion of Pharmacogenomic results during the PMR OTHER

Return of pharmacogenomic results and discussion of impact on medications.

Immediate Return of Pharmacogenomic Results

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>/= 18 years old
• Enrolled in the UPMC insurance plan for at least 1 year
• Identified by UPMC Healthplan as a Pitt/UPMC employee who is likely to benefit from preemptive PGx panel testing based on polypharmacy, high annual prescription costs and a risk for poor medication-related outcomes based on exposure to medications with FDA or CPIC Level A/B PGx guidance using payer data
• Participating in Pitt+Me Discovery with elective return of PGx results

You may not qualify if:

• Previous panel PGx testing (self-reported)
• Have a terminal illness (specifically metastatic cancer, palliative care or hospice)
• Have had a liver, small bowel, or allogenic bone marrow/stem cell transplant
• Cannot provide informed consent and/or complete the study protocol due to serious cognitive impairment
• Institutionalized or too ill to participate (i.e. incarcerated, psychiatric or nursing home facility)
• Plan to drop UPMC Health Plan coverage for any reason within 12 months of enrollment

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Study Officials

• Philip E Empey, PharmD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 28, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)