The goal of this prospective, randomized clinical trial is to learn whether pharmacogenomic (PGx)-guided comprehensive medication management delivered by pharmacists in community pharmacies will improve antidepressant treatment outcomes.
The primary aim is to determine whether comprehensive medication management with review of PGx testing results improves depression symptoms, compared with usual care.
Participants 18 years of age or older who have undergone PGx testing (e.g. through an independent biobanking study (Pitt+Me Discovery) who require initiation or adjustment of antidepressant therapy will be randomly assigned to receive either PGx-guided comprehensive medication management or usual care. Those who receive usual care will receive their PGx results at the end of the study. Researchers will compare the groups to assess whether PGx-guided care provided in partnership with community pharmacists and prescribers results in better depression and medication outcomes.
New prescription or change in dose/schedule of SSRI (citalopram, escitalopram, sertraline, paroxetine), OR
Concurrent SSRI (citalopram, escitalopram, sertraline, paroxetine) and new prescription/change in SNRI (desvenlafaxine, duloxetine, and venlafaxine) / bupropion.
Depressive symptoms confirmed by PHQ8 assessment (>5 indicating at least mild depressive symptoms)
UPMC patient (or able/willing to become one) and has UPMC provider (or able/willing to obtain one)
Inability to receive CMM at specific pharmacy/pharmacist
Comorbid diagnosis of schizophrenia (patient-reported)
Untreated sleep disorder (patient-reported)
Pitt+Me Discovery participant who has elected to not receive return of results, or who has already received results previously
Parallel
Comprehensive medication management with PGx testing results
Other interventionA comprehensive medication management with PGx testing includes a pharmacist-provided review of health history, past/current medications, and assessment of potential medication related problems. A review of PGx testing results will be integrated to identify any PGx-related medication issues. Recommendations will then be made to study participants' providers (regular care team) for any decisions regarding potential therapy changes.
Usual Care
Other interventionParticipants will receive no study intervention (usual care) and will have a comprehensive medication management with review of PGx testing results at the end of the study.
Change in Patient Health Questionnaire (PHQ-8) score
The Patient Health Questionnaire-8 (PHQ-8) is an 8-item self-report measure assessing depressive symptoms. Each item is scored from 0-3, producing a total score of 0-24, with higher scores indicating more severe depressive symptoms. Standard severity categories are minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-24).
Change in the Extent of Adherence and Reasons for Nonadherence Survey (Voils et al.) score
The Extent of Adherence and Reasons for Nonadherence Survey (Voils et al.) is a validated self-report measure assessing medication adherence over the past 7 days. It is scored on a 1-5 Likert scale and averaged to produce a continuous score, with higher scores indicating better adherence. The Reasons for Nonadherence scale assesses specific barriers to taking medication as prescribed, with items rated on a 1-5 scale and assessed individually to identify the degree to which each barrier contributed to missed doses.
Change in Generalized Anxiety Disorder Assessment (GAD-7) score
The Generalized Anxiety Disorder Assessment (GAD-7) is a 7-item self-report measure assessing anxiety symptoms over the past two weeks, with items scored 0-3 for a total score of 0-21; higher scores indicate more severe anxiety, categorized as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21).
Proportion of pharmacist recommendations were accepted
Proportion of pharmacist recommendations to address medication-related problems that were accepted by providers as assessed by EHR and fill data review.
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.
Community pharmacists' needs for expert support in deploying PGx
Community pharmacists' needs for expert support in deploying PGx Number and types of questions asked by community pharmacists to PGx experts on study team through the duration of the study.
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University of Pittsburgh
Lead sponsor
Pennsylvania Department of Health
Collaborator
