Pharmacogenetics, Pharmacogenomic Drug Interaction
Conditions
Keywords
Precision Medicine, Medication Review, PGx, Pharmacist, Pharmacogenomics, Employee health
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.
Interventions
OTHERPharmacist Personalized Medication Review (PMR)
Pharmacist-provided review of current medications and assessment of potential medication related problems.
OTHERDiscussion of Pharmacogenomic results during the PMR
Return of pharmacogenomic results and discussion of impact on medications.
Sponsors
University of Pittsburgh
University of Pittsburgh Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Per Member Per Month (PMPM) Healthcare Costs | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in frequency of CPIC/FDA guideline concordant prescribing | 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. |
| Change in healthcare utilization | 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. |
| Number of adverse events as assessed using the Patient-Reported Outcome Measure, Inquiry into Side-Effects (PROMISE) survey | 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. |
| Change in Medication Access and Adherence Tool (MAAT) Score | 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. |
| Health-systems Alliance for Integrated Medication Management (HAIMM) Score after Personalized Medication Review | 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. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) | 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. |
| Proportion of pharmacist recommendations were accepted | 12 months after PMR visit | Proportion of pharmacist recommendations to address medication-related problems that were accepted by providers as assessed by EHR review. |
| Frequency of Actionable Genotypes | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPhilip E Empey, PharmD, PhD
University of Pittsburgh
Outcome results
None listed