Clinical trial NCT06660264: An Evaluation of the Impact of Pharmacist Personalized Medication Reviews With and Without a Discussion of Pharmacogenomic Results in an Employee Health Program.
Official title: Implementing Risk-Based Preemptive Pharmacogenomic (PGx) Testing in Employee Health
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pharmacogenetics
Pharmacogenomic Drug Interaction
Keywords: Precision Medicine
Medication Review
PGx
Pharmacist
Pharmacogenomics
Employee health
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Medical Center
First posted: 2024-10-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Change in Total Per Member Per Month (PMPM) Healthcare Costs
timeFrame: From 12 Months prior to PMR visit and from the PMR visit to 12 Months after the PMR visit
Secondary outcomes:
measure: Change in frequency of CPIC/FDA guideline concordant prescribing
timeFrame: Baseline, 12 Months after PMR visit
measure: Change in healthcare utilization
timeFrame: From 12 Months prior to PMR visit and from the PMR visit to 12 Months after the PMR visit.
measure: Number of adverse events as assessed using the Patient-Reported Outcome Measure, Inquiry into Side-Effects (PROMISE) survey
timeFrame: 6 Months after PMR visit
measure: Change in Medication Access and Adherence Tool (MAAT) Score
timeFrame: Baseline, 6 Months after PMR
measure: Health-systems Alliance for Integrated Medication Management (HAIMM) Score after Personalized Medication Review
timeFrame: After the PMR visit (up to 14 days after)
measure: Health-systems Alliance for Integrated Medication Management (HAIMM) Score after Personalized Medication Review
timeFrame: 6 Months after PMR visit
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline, 6 Months after PMR visit
measure: Proportion of pharmacist recommendations were accepted
timeFrame: 12 months after PMR visit
measure: Frequency of Actionable Genotypes
timeFrame: At 12 months after PMR visit
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Philip E Empey, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: