Back to resultsAssessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans
Primary Purpose
Pharmacogenetics, Depressive Disorder, Major, Medication Therapy Management
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacogenomic Screening
Sponsored by
About this trial
This is an interventional screening trial for Pharmacogenetics
Eligibility Criteria
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
Sites / Locations
- Tuscaloosa VAMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pharmacogenomic Screening
Arm Description
Eligible patients who verbally consent to participate will receive two pharmacogenomics telehealth visits.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rate of pharmacogenomic variation with actionable recommendations for all actionable medications
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.
Medication-related costs
Claims data will be used to assess medication-related costs at specific time points.
Medication-related adverse events
Number of primary care, mental health provider, mental health pharmacist, specialist, and emergency room visits and hospitalizations
Patient reported medication adherence and reasons for non-adherence
Patient reported reasons for non-adherence
Number of pharmacogenomic recommendations made and accepted
Type of pharmacogenomic recommendations made and accepted
Number of non-pharmacogenomic recommendations made and accepted
Type of non-pharmacogenomic recommendations made and accepted
Full Information
NCT ID
NCT04893395
First Posted
May 12, 2021
Last Updated
August 8, 2022
Sponsor
Auburn University
Collaborators
Tuscaloosa Veterans Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04893395
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Does not meet criteria for a clinical trial per IRB review.
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
Collaborators
Tuscaloosa Veterans Affairs Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharmacogenetics, Depressive Disorder, Major, Medication Therapy Management
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacogenomic Screening
Arm Type
Experimental
Arm Description
Eligible patients who verbally consent to participate will receive two pharmacogenomics telehealth visits.
Intervention Type
Other
Intervention Name(s)
Pharmacogenomic Screening
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of pharmacogenomic variation with actionable recommendations for medications currently utilized
Description
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.
Time Frame
At enrollment
Secondary Outcome Measure Information:
Title
Rate of pharmacogenomic variation with actionable recommendations for all actionable medications
Time Frame
At enrollment
Title
Mental health disease state control/progression utilizing disease state-specific validated tools
Description
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.
Time Frame
3-, 6-, and 12-months post-recommendation via retrospective chart review
Title
Medication-related costs
Description
Claims data will be used to assess medication-related costs at specific time points.
Time Frame
3-, 6-, and 12-months post-recommendation via retrospective chart review
Title
Medication-related adverse events
Time Frame
3-, 6-, and 12-months post-recommendation via retrospective chart review
Title
Number of primary care, mental health provider, mental health pharmacist, specialist, and emergency room visits and hospitalizations
Time Frame
3-, 6-, and 12-months post-recommendation via retrospective chart review
Title
Patient reported medication adherence and reasons for non-adherence
Time Frame
3-, 6-, and 12-months post-recommendation via retrospective chart review
Title
Patient reported reasons for non-adherence
Time Frame
3-, 6-, and 12-months post-recommendation via retrospective chart review
Title
Number of pharmacogenomic recommendations made and accepted
Time Frame
3-, 6-, and 12-months post-recommendation via retrospective chart review
Title
Type of pharmacogenomic recommendations made and accepted
Time Frame
3-, 6-, and 12-months post-recommendation via retrospective chart review
Title
Number of non-pharmacogenomic recommendations made and accepted
Time Frame
3-, 6-, and 12-months post-recommendation via retrospective chart review
Title
Type of non-pharmacogenomic recommendations made and accepted
Time Frame
3-, 6-, and 12-months post-recommendation via retrospective chart review
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly B Lloyd, Pharm.D.
Organizational Affiliation
Auburn University
Official's Role
Study Director
Facility Information:
Facility Name
Tuscaloosa VAMC
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans
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