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

Sponsor
Auburn University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04893395
Collaborator
Tuscaloosa Veterans Affairs Medical Center (U.S. Fed)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pharmacogenomic Screening
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pharmacogenomic Screening

Eligible patients who verbally consent to participate will receive two pharmacogenomics telehealth visits.

Other: Pharmacogenomic Screening
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

Outcome Measures

Primary Outcome Measures

  1. Rate of pharmacogenomic variation with actionable recommendations for medications currently utilized [At enrollment]

    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.

Secondary Outcome Measures

  1. Rate of pharmacogenomic variation with actionable recommendations for all actionable medications [At enrollment]

  2. Mental health disease state control/progression utilizing disease state-specific validated tools [3-, 6-, and 12-months post-recommendation via retrospective chart review]

    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. Medication-related costs [3-, 6-, and 12-months post-recommendation via retrospective chart review]

    Claims data will be used to assess medication-related costs at specific time points.

  4. Medication-related adverse events [3-, 6-, and 12-months post-recommendation via retrospective chart review]

  5. 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]

  6. Patient reported medication adherence and reasons for non-adherence [3-, 6-, and 12-months post-recommendation via retrospective chart review]

  7. Patient reported reasons for non-adherence [3-, 6-, and 12-months post-recommendation via retrospective chart review]

  8. Number of pharmacogenomic recommendations made and accepted [3-, 6-, and 12-months post-recommendation via retrospective chart review]

  9. Type of pharmacogenomic recommendations made and accepted [3-, 6-, and 12-months post-recommendation via retrospective chart review]

  10. Number of non-pharmacogenomic recommendations made and accepted [3-, 6-, and 12-months post-recommendation via retrospective chart review]

  11. Type of non-pharmacogenomic recommendations made and accepted [3-, 6-, and 12-months post-recommendation via retrospective chart review]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tuscaloosa VAMC Tuscaloosa Alabama United States 35404

Sponsors and Collaborators

  • Auburn University
  • Tuscaloosa Veterans Affairs Medical Center

Investigators

  • Study Director: Kimberly B Lloyd, Pharm.D., Auburn University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Courtney Watts Alexander, Assistant Professor, Auburn University
ClinicalTrials.gov Identifier:
NCT04893395
Other Study ID Numbers:
  • TVA_IRBNetID_1614352
First Posted:
May 19, 2021
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022