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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Pharmacist Personalized Medication Review (PMR)
  Pharmacist-provided review of current medications and assessment of potential medication related problems.
• Другое Discussion of Pharmacogenomic results during the PMR
  Return of pharmacogenomic results and discussion of impact on medications.

Первичные конечные точки

• Change in Total Per Member Per Month (PMPM) Healthcare Costs [Срок оценки: From 12 Months prior to PMR visit and from the PMR visit to 12 Months after the PMR visit]

Вторичные конечные точки (9)

• Change in frequency of CPIC/FDA guideline concordant prescribing [Срок оценки: Baseline, 12 Months after PMR visit]
• Change in healthcare utilization [Срок оценки: 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 [Срок оценки: 6 Months after PMR visit]
• Change in Medication Access and Adherence Tool (MAAT) Score [Срок оценки: Baseline, 6 Months after PMR]
• Health-systems Alliance for Integrated Medication Management (HAIMM) Score after Personalized Medication Review [Срок оценки: After the PMR visit (up to 14 days after)]
• Health-systems Alliance for Integrated Medication Management (HAIMM) Score after Personalized Medication Review [Срок оценки: 6 Months after PMR visit]
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) [Срок оценки: Baseline, 6 Months after PMR visit]
• Proportion of pharmacist recommendations were accepted [Срок оценки: 12 months after PMR visit]
• Frequency of Actionable Genotypes [Срок оценки: At 12 months after PMR visit]

Критерии участия

Критерии включения

• >/= 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06660264 · STUDY23050142

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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