Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans

Study Overview
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Brief Summary
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The purpose of this study is to assess the prevalence of veterans with major depressive disorder (MDD) who are being treated with a medication that has current Clinical Pharmacogenetics Implementation Consortium (CPIC) or Pharmacogenomics Knowledgebase (PharmGKB) actionable recommendations that have a pharmacogenomic variation that impacts the safety or efficacy of the subject medication.

Official Title
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Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans

Conditions
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Pharmacogenetics, Depressive Disorder, Major, Medication Therapy Management

Intervention / Treatment
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* Other: Pharmacogenomic Screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 19 years Prescribed at least one chronic medication for mental health which is considered pharmacogenomically actionable, as defined above (amitriptyline, doxepin, imipramine, nortriptyline, citalopram, escitalopram, fluvoxamine, paroxetine, sertraline, or venlafaxine). Diagnosis of major depressive disorder (MDD) Exclusion Criteria: Subject is a prisoner or is under a court order for treatment as part of a sentence or incarceration Persistent medication non-adherence for reasons not potentially linked to pharmacogenomic variation (e.g. inability to obtain medications due to cost; non-adherence due to cognitive impairment) Individuals receiving mental health treatment/care from a non-VA facility Individuals who are terminally ill Inability to communicate in and/or understand English

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacogenomic Screening<br>Eligible patients who verbally consent to participate will receive two pharmacogenomics telehealth visits. | Other: Pharmacogenomic Screening<br>* First telehealth appointment: Pharmacogenomics education and informed consent Medical history Sample collection Second telehealth appointment: Results of pharmacogenomic testing Utility and limitations of pharmacogenomic testing Patient-specific potential impacts on current or future medication therapies Answering of patient questions Referral to mental health provider(s) for treatment-specific recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of pharmacogenomic variation with actionable recommendations for medications currently utilized | A medication history will be conducted at enrollment to ensure patient meets criteria for enrollment. Patients will provide a saliva sample at this timepoint. The rate of pharmacogenomic variation will be calculated based on current medications at enrollment; however, the pharmacogenomic screening panel may take up to 6 weeks to return to the patient and investigator. | At enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of pharmacogenomic variation with actionable recommendations for all actionable medications |  | At enrollment | 
| Mental health disease state control/progression utilizing disease state-specific validated tools | Validated, disease state-specific tools will be utilized to assess control or progression. Specifically, depression control will be assessed utilizing PHQ-9 as documented within the chart. This will be assessed via retrospective chart review. | 3-, 6-, and 12-months post-recommendation via retrospective chart review | 
| Medication-related costs | Claims data will be used to assess medication-related costs at specific time points. | 3-, 6-, and 12-months post-recommendation via retrospective chart review | 
| Medication-related adverse events |  | 3-, 6-, and 12-months post-recommendation via retrospective chart review | 
| Number of primary care, mental health provider, mental health pharmacist, specialist, and emergency room visits and hospitalizations |  | 3-, 6-, and 12-months post-recommendation via retrospective chart review | 
| Patient reported medication adherence and reasons for non-adherence |  | 3-, 6-, and 12-months post-recommendation via retrospective chart review | 
| Patient reported reasons for non-adherence |  | 3-, 6-, and 12-months post-recommendation via retrospective chart review | 
| Number of pharmacogenomic recommendations made and accepted |  | 3-, 6-, and 12-months post-recommendation via retrospective chart review | 
| Type of pharmacogenomic recommendations made and accepted |  | 3-, 6-, and 12-months post-recommendation via retrospective chart review | 
| Number of non-pharmacogenomic recommendations made and accepted |  | 3-, 6-, and 12-months post-recommendation via retrospective chart review | 
| Type of non-pharmacogenomic recommendations made and accepted |  | 3-, 6-, and 12-months post-recommendation via retrospective chart review |