Trial of Preemptive Pharmacogenetics in Underserved Patients (NCT05141019) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Trial of Preemptive Pharmacogenetics in Underserved Patients
United States492 participantsStarted 2022-08-01
Plain-language summary
This proposed research is relevant to human health because preemptive clinical pharmacogenetic testing may improve the personalization of drug therapy which should improve patient outcomes. Better understanding of the effectiveness and feasibility of preemptive clinical pharmacogenetic testing will inform when and how this innovative healthcare technology is implemented into clinical care. To ensure equitable dissemination in all patient populations, such data is also needed in racial minorities and other traditionally underserved populations. The combined proposed research are relevant to the parts of the NIH's mission pertaining to protecting and improving health and developing scientific human resources that will ensure the Nation's capability to prevent and treat disease.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults \> 18 years of age
* at least 3 active prescriptions documented within medical records
* Experienced a change to an active prescription within the past 8 months, defined by:
* Addition of a new medication
* Change in the dose of a current medication
* Diagnosis of any condition that could be treated with a medication that can be informed by the pharmacogenetic testing panel.
This will likely include:
* generalized depression or anxiety disorder
* gastroesophageal reflux disorder
* erosive esophagitis
* gastric ulcer
* acute coronary syndrome
* chronic pain
* surgery (orthopedic, gastrointestinal, cardiovascular etc.)
* osteoarthritis
* Dyslipidemia
* Heart failure
* Deep vein thrombosis
* Atrial fibrillation
* Moderate to severe trauma
* stroke
* hypercholesterolemia
* conditions requiring chronic anticoagulation
Exclusion Criteria:
* Any history of previous pharmacogenetic testing
* Any medical condition that would prohibit the ability to answer study questions
* History of Allogenic stem cell or liver transplant
* History of chronic kidney dialysis
* Life expectancy less than 12 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Patient Treatment Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)