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

NCT ID: NCT06660264

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2027-06-30

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

Study Design

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

Study Groups

Immediate Return of Pharmacogenomic Results

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.

Group Type: OTHER

Pharmacist Personalized Medication Review (PMR)

Intervention Type: OTHER

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

Discussion of Pharmacogenomic results during the PMR

Intervention Type: OTHER

Return of pharmacogenomic results and discussion of impact on medications.

Delayed Return of Pharmacogenomic Results

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.

Group Type: OTHER

Pharmacist Personalized Medication Review (PMR)

Intervention Type: OTHER

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

Interventions

Pharmacist Personalized Medication Review (PMR)

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

Intervention Type: OTHER

Discussion of Pharmacogenomic results during the PMR

Return of pharmacogenomic results and discussion of impact on medications.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• >/= 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

Exclusion Criteria

• 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
• Recent blood transfusion may be exclusionary only if the end of recruitment is nearing and there is insufficient time to observe a minimum waiting period between date of transfusion and date of sample collection. These minimum waiting periods are determined by type of transfusion: 7 days for platelets/plasma/cryoprecipitate; 2 months for packed red blood cells (PRBCs): and 6 months for whole blood or unknown type of transfusion. Although a transfusion is unlikely to have major effects on genotype results from a saliva sample, these time windows remove this concern.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh Medical Center

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Philip Empey

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip E Empey, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY23050142

Identifier Type: -

Identifier Source: org_study_id