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Does not meet criteria for a clinical trial per IRB review.
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| Name | Class |
|---|---|
| Tuscaloosa Veterans Affairs Medical Center | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacogenomic Screening | Experimental | Eligible patients who verbally consent to participate will receive two pharmacogenomics telehealth visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacogenomic Screening | Other | First telehealth appointment:
Second telehealth appointment:
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly B Lloyd, Pharm.D. | Auburn University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tuscaloosa VAMC | Tuscaloosa | Alabama | 35404 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000071185 | Pharmacogenomic Testing |
| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| 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 |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |