Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Pittsburgh Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Return of Pharmacogenomic Results | Other | Participants will be randomized to immediate versus delayed return of pharmacogenomic results obtained from testing conducted by an independent biobanking study (Pitt+Me Discovery). Participants in the immediate group will receive a pharmacist Personalized Medication Review with PGx results. |
|
| Delayed Return of Pharmacogenomic Results | Other | Participants will be randomized to immediate versus delayed return of pharmacogenomic results obtained from testing conducted by an independent biobanking study. Participants in the delayed group with receive a pharmacist Personalized Medication Review without PGx results. The delayed group will receive results from the independent biobanking study (Pitt+Me Discovery) at 12 months after the Personalized Medication Review. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist Personalized Medication Review (PMR) | Other | Pharmacist-provided review of current medications and assessment of potential medication related problems. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Per Member Per Month (PMPM) Healthcare Costs | 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. | From 12 Months prior to PMR visit and from the PMR visit to 12 Months after the PMR visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of CPIC/FDA guideline concordant prescribing | 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. | Baseline, 12 Months after PMR visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philip E Empey, PharmD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Discussion of Pharmacogenomic results during the PMR | Other | Return of pharmacogenomic results and discussion of impact on medications. |
|
| Change in healthcare utilization | 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. | 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 | 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. | 6 Months after PMR visit |
| Change in Medication Access and Adherence Tool (MAAT) Score | 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. | Baseline, 6 Months after PMR |
| Health-systems Alliance for Integrated Medication Management (HAIMM) Score after Personalized Medication Review | 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. | After the PMR visit (up to 14 days after) |
| Health-systems Alliance for Integrated Medication Management (HAIMM) Score after Personalized Medication Review | 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 Months after PMR visit |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) | 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. | Baseline, 6 Months after PMR visit |
| Proportion of pharmacist recommendations were accepted | Proportion of pharmacist recommendations to address medication-related problems that were accepted by providers as assessed by EHR review. | 12 months after PMR visit |
| Frequency of Actionable Genotypes | 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. | At 12 months after PMR visit |