Clinical trial NCT04893395: Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans
Official title: Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pharmacogenetics
Depressive Disorder, Major
Medication Therapy Management
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: Tuscaloosa Veterans Affairs Medical Center
First posted: 2021-05-19
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 19 years
2. 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).
3. Diagnosis of major depressive disorder (MDD)

Exclusion Criteria:

1. Subject is a prisoner or is under a court order for treatment as part of a sentence or incarceration
2. 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)
3. Individuals receiving mental health treatment/care from a non-VA facility
4. Individuals who are terminally ill
5. Inability to communicate in and/or understand English

Primary outcomes:
measure: Rate of pharmacogenomic variation with actionable recommendations for medications currently utilized
timeFrame: At enrollment
Secondary outcomes:
measure: Rate of pharmacogenomic variation with actionable recommendations for all actionable medications
timeFrame: At enrollment
measure: Mental health disease state control/progression utilizing disease state-specific validated tools
timeFrame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
measure: Medication-related costs
timeFrame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
measure: Medication-related adverse events
timeFrame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
measure: Number of primary care, mental health provider, mental health pharmacist, specialist, and emergency room visits and hospitalizations
timeFrame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
measure: Patient reported medication adherence and reasons for non-adherence
timeFrame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
measure: Patient reported reasons for non-adherence
timeFrame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
measure: Number of pharmacogenomic recommendations made and accepted
timeFrame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
measure: Type of pharmacogenomic recommendations made and accepted
timeFrame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
measure: Number of non-pharmacogenomic recommendations made and accepted
timeFrame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
measure: Type of non-pharmacogenomic recommendations made and accepted
timeFrame: 3-, 6-, and 12-months post-recommendation via retrospective chart review
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VAMC
state: Alabama
Study officials:
affiliation: Auburn University
name: Kimberly B Lloyd, Pharm.D.
role: STUDY_DIRECTOR
References: