An Evaluation of the Impact of Pharmacist Personalized Medication Reviews With and Without a Discussion of Pharmacogenomic Results in an Employee Health Program. (MyPGx)
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Details and patient eligibility
About
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.
Enrollment
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
600 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Linda Prebehalla, RN; Philip E Empey, PharmD, PhD
Data sourced from clinicaltrials.gov
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