Community Pharmacy Services, Depression - Major Depressive Disorder, Pharmacogenetics, Pharmacogenomic Drug Interaction
Conditions
Keywords
precision medicine, pharmacogenomics, PGx, Comprehensive medication management, pharmacist, community pharmacy, medication review, antidepressants, pharmacogenomic testing, management of depression
Brief summary
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.
Interventions
OTHERComprehensive medication management with PGx testing results
A 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.
OTHERUsual Care
Participants 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.
Sponsors
University of Pittsburgh
Pennsylvania Department of Health
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
* At targeted community pharmacy for: * 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) * Signed consent to join Pitt+Me Discovery biobanking research study. * English-speaking
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire (PHQ-8) score | Baseline, 6 Weeks, 12 Weeks, 6 Months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Extent of Adherence and Reasons for Nonadherence Survey (Voils et al.) score | Baseline, 6 Months | 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 | Baseline, 6 Weeks, 12 Weeks, 6 Months | 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 | 6 months | 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 | Baseline, 6 Months | 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. |
| Number of adverse events as assessed using the Frequency, Intensity, and Burden of Side Effect rating scale (FIBSER). | Baseline, 6 Weeks, 12 Weeks, 6 Months | The Frequency, Intensity, and Burden of Side Effect Rating Scale (FIBSER) is a 3-item self-report measure assessing medication side effects. It evaluates the frequency, intensity, and functional burden of side effects over the past week, with each item rated on a 0-6 scale; higher scores indicate more frequent, severe, or burdensome side effects. Clinically, a total score of 0-2 typically requires no change in treatment, 3-4 side effects may warrant targeted management, and 5-6 indicates that treatment modification should be considered to improve tolerability and adherence. |
| Frequency of Actionable Genotypes | 6 months | 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. |
| Number of participant medications with PGx guidance based on PGx testing results. | 6 months | This measure counts the number of a participant's medications for which pharmacogenomic (PGx) guidance is available based on PGx testing results. Medications with PGx guidance may have dosing recommendations, alternative drug options, or monitoring considerations informed by the participant's genetic profile. |
| Change in healthcare utilization | From Baseline to 6 Months | Change in participant ER visits, hospitalizations, urgent care visits, specialist appointments, primary care appointments, and unplanned care using UPMC EHR data. |
Countries
United States
Contacts
CONTACTLinda Prebehalla, RN
CONTACTPhilip E Empey, PharmD, PhD
PRINCIPAL_INVESTIGATORPhilip E Empey, PharmD, PhD
University of Pittsburgh
Outcome results
None listed