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Enrolling by Invitation

NCT Number: NCT06660264

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

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.

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Key information

Conditions

Pharmacogenetics Pharmacogenomic Drug Interaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacist Personalized Medication Review (PMR)

Other

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

Discussion of Pharmacogenomic results during the PMR

Other

Return of pharmacogenomic results and discussion of impact on medications.

Primary outcomes

  1. Change in Total Per Member Per Month (PMPM) Healthcare Costs

    Time frame: From 12 Months prior to PMR visit and from the PMR visit to 12 Months after the PMR visit

    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.

Secondary outcomes

  1. Change in frequency of CPIC/FDA guideline concordant prescribing

    Time frame: Baseline, 12 Months after PMR visit

    Change in frequency of concordance of participant medication regimen with pharmacogenomics prescribing recommendations according to the Clinical Pharmacogenomics Implementation Consortium (CPIC) and U.S. Food & Drug Administration (FDA) guidelines using electronic health record data.

  2. Change in healthcare utilization

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

    Change in participant ER visits, hospitalizations, urgent care visits, specialist appointments, primary care appointments and unplanned care using UPMC Health Plan claims data from the year prior to the year after the pharmacist PMR visit.

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

    Time frame: 6 Months after PMR visit

    The Patient-Reported Outcome Measure, Inquiry into Side-Effects (PROMISE) allows participants to report common symptoms and suspected drug-related adverse events they may have experienced in the previous month. It includes a list of 22 common symptoms with option to write in other symptoms. For each symptom reported they are asked to indicate if they believe it might be a possible side effect of their medication. Scores range from 0 to 23. Higher scores indicate greater number of reported symptoms.

  4. Change in Medication Access and Adherence Tool (MAAT) Score

    Time frame: Baseline, 6 Months after PMR

    The Medication Access and Adherence Tool (MAAT) will be used to assess change in medication adherence from Baseline to 6 Months. The MAAT is a tool that assesses participant-reported medication adherence. There are 5 questions with a score for each ranging from (1) not sure at all to (3) very sure. Possible scores range from 5 to 15, with higher scores indicating better medication adherence.

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

    Time frame: After the PMR visit (up to 14 days after)

    The Health-systems Alliance for Integrated Medication Management (HAIMM) survey will be used to assess participant-reported understanding and satisfaction after the Personalized Medication Review session with the study pharmacist. The HAIMM contains 10 questions. Scores range from (0) not applicable to (4) strongly agree for 9 questions, and (1) poor to (5) excellent for the tenth question. Possible scores range from 4 to 41, with higher scores indicating greater participant satisfaction.

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

    Time frame: 6 Months after PMR visit

    The Health-systems Alliance for Integrated Medication Management (HAIMM) survey will be used to assess participant-reported understanding and satisfaction after the Personalized Medication Review session with the study pharmacist. The HAIMM contains 10 questions. Scores range from (0) not applicable to (4) strongly agree for 9 questions, and (1) poor to (5) excellent for the tenth question. Possible scores range from 4 to 41, with higher scores indicating greater participant satisfaction.

  7. Change in Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: Baseline, 6 Months after PMR visit

    The Patient-Reported Outcomes Measurement Information System (PROMIS) survey measures health across 7 domains including cognition, depression, fatigue, pain, physical fitness, sleep and social roles. The Promis Preference (PROPr) Utility Score will be used to combine 7 PROMIS domains into a single health utility score. There are 14 questions and responses range from (1) Not at all to (5) Very much. Scores range from 14 to 70, with higher scores indicating better general health.

  8. Proportion of pharmacist recommendations were accepted

    Time frame: 12 months after PMR visit

    Proportion of pharmacist recommendations to address medication-related problems that were accepted by providers as assessed by EHR review.

  9. Frequency of Actionable Genotypes

    Time frame: At 12 months after PMR visit

    Frequency of actionable genotypes (in the entire study population) based on report of a genotype-predicted phenotype. Actionable genotypes are defined as those with recommendations for a change in prescribing by a CPIC (Clinical Pharmacogenetics Implementation Consortium) guidelines or FDA recommendations.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • University of Pittsburgh Medical Center

Registry information

Official study title

Implementing Risk-Based Preemptive Pharmacogenomic (PGx) Testing in Employee Health

Acronym: MyPGx

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 28, 2024
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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