An Evaluation of the Impact of Pharmacist Personalized Medication Reviews With and Without a Discussion of Pharmacogenomic Results in an Employee Health Program.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pharmacist Personalized Medication Review (PMR), Discussion of Pharmacogenomic results during the PMR.
- Who it may be relevant to
- Registry conditions: Pharmacogenetics, Pharmacogenomic Drug Interaction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Implementing Risk-Based Preemptive Pharmacogenomic (PGx) Testing in Employee Health
Overview
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.
Interventions
- Other Pharmacist Personalized Medication Review (PMR)
Pharmacist-provided review of current medications and assessment of potential medication related problems. - Other Discussion of Pharmacogenomic results during the PMR
Return of pharmacogenomic results and discussion of impact on medications.
Primary outcome measures
- 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]
Secondary outcome measures (9)
- Change in frequency of CPIC/FDA guideline concordant prescribing [Time frame: Baseline, 12 Months after PMR visit]
- 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.]
- 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]
- Change in Medication Access and Adherence Tool (MAAT) Score [Time frame: Baseline, 6 Months after PMR]
- Health-systems Alliance for Integrated Medication Management (HAIMM) Score after Personalized Medication Review [Time frame: After the PMR visit (up to 14 days after)]
- Health-systems Alliance for Integrated Medication Management (HAIMM) Score after Personalized Medication Review [Time frame: 6 Months after PMR visit]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) [Time frame: Baseline, 6 Months after PMR visit]
- Proportion of pharmacist recommendations were accepted [Time frame: 12 months after PMR visit]
- Frequency of Actionable Genotypes [Time frame: At 12 months after PMR visit]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT06660264 · STUDY23050142