Pharmacogenetic Testing for Complex Medical Needs

(CAREPICC Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Acute illness, Prior testing, Wards, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores caregivers' openness to pharmacogenetic testing, which examines how a child's genes might influence their response to certain medications. It focuses on children with complex medical needs in Cincinnati, OH, and assesses whether offering the test for free encourages caregiver participation. The trial also investigates other potential barriers and caregivers' perceptions of the testing. Suitable candidates include children who regularly visit the Cincinnati Children's Complex Care Clinic for ongoing health management and have a legal guardian present during clinic visits. Participants will receive the testing at no cost and may be asked to complete a survey or interview about their experience. As an unphased trial, this study provides a unique opportunity for caregivers to contribute to research that could enhance personalized medicine for children.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing attitudes towards pharmacogenetic testing rather than changing current treatments.

What prior data suggests that pharmacogenetic testing is safe for complex care patients?

Research has shown that pharmacogenetic testing can predict how someone might respond to certain medications. This testing indicates whether a drug will work well or cause side effects. Studies have found that using this testing can make medications safer by reducing unexpected reactions, leading to fewer side effects and better overall results.

Pharmacogenetic testing also improves healthcare use, benefiting patients. It enhances how medications are prescribed and taken, resulting in fewer doctor visits and more effective treatments.

While this specific trial focuses on perceptions of pharmacogenetic testing, existing evidence supports its safety and benefits in customizing medications to fit individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pharmacogenetic testing because it personalizes treatment plans based on a child's genetic makeup. Unlike traditional treatments that adopt a one-size-fits-all approach, this method allows caregivers and doctors to tailor medical care to the individual's unique genetic profile. This means medications and dosages can be chosen more precisely, potentially improving effectiveness and reducing side effects. It's a promising step towards more customized and effective healthcare solutions.

What evidence suggests that Pharmacogenetic Testing is effective for complex care patients?

Research has shown that pharmacogenetic testing can help create personalized medicine by identifying the right drug and dose for each person. In one study, nearly 1 in 4 tests produced results that could alter a patient's treatment plan. This enables doctors to select safer and more effective medications. Another review suggested that using these tests might even reduce healthcare costs over a year. In this trial, caregivers who consent to pharmacogenetic testing for their child will participate in the study. Pharmacogenetic testing resembles other routine tests, such as liver function checks, making it a promising tool for improving patient care. ^{6 7 8 9 10}

Who Is on the Research Team?

Sonya Tang Girdwood

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for caregivers of children with complex medical needs in Cincinnati, OH. It's designed to see if these caregivers would agree to free Pharmacogenetic testing for their kids and identify any barriers they face.

Inclusion Criteria

Patients who score a 3 on the Pediatric Medical Complexity Algorithm

Patients whose primary care providers are those at the Cincinnati Children's Complex Care Clinic

Patients attending the Cincinnati Children's Hospital Complex Care Clinic for well child visit

Exclusion Criteria

Patients attending the Complex Care Clinic for acute illness

Patients deemed ineligible for approach by the clinical team

Patients who are wards of the state

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pharmacogenetic Testing

Participants are offered pharmacogenetic testing for their child free of charge

1 day

1 visit (in-person)

Survey and Interview

Caregivers fill out a voluntary survey and may participate in a semi-structured interview

6 months

Follow-up

Participants are monitored for attitudes and barriers towards pharmacogenetic testing

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Agree to Pharmacogenetic Testing

Trial Overview The study tests the acceptance of Pharmacogenetic Testing when cost isn't an issue. Caregivers will be given the test at no charge and asked to complete a survey, with some participating in an interview.

How Is the Trial Designed?

Group I: Accept Pharmacogenetic Testing Experimental Treatment 1 Intervention

Caregivers who agree to receive Pharmacogenetic testing for their child

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5511786/

The Pharmacogenomics Research Network Translational ... And finally, nearly 1 out of 4 pharmacogenetic tests had a potentially actionable result, which demonstrated the numerous potential opportunities to personalize ...

2. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.3704

Navigating Pharmacogenomic Testing in Practice: Who to Test ... This mini-review provided critical considerations to aid health systems and providers in deciding how to best adopt PGx testing in clinical practice.

3. nature.com nature.com/articles/s41397-021-00260-6

a systematic review | The Pharmacogenomics Journal The investigators hypothesise that pharmacogenetic testing and pharmacist review of medication appropriateness will lower one-year healthcare ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1098360024002429

Trends in and predictors of patient pharmacogenomic test ... This study highlights factors that may facilitate or hinder the widespread and equitable implementation of PGx testing in a large national health care system.

5. bps.ac.uk bps.ac.uk/getmedia/b43a3dca-1bbf-4bff-9379-20bef9349a8c/Personalised-prescribing-full-report.pdf.aspx

Using pharmacogenomics to improve patient outcomes Framing pharmacogenetic testing as being similar to liver or renal function tests also guards against genetic exceptionalism, ie the belief that genetic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3969027/

The Potential Impact of Pharmacogenetic Testing on ... In this paper, we discuss the potential mechanisms by which PGx testing may affect medication-taking behavior – either positively or negatively.

7. cdc.gov cdc.gov/genomics-and-health/pharmacogenomics/index.html

Pharmacogenomics | Genomics and Your Health Pharmacogenomics can improve your health by helping you know ahead of time whether a drug is likely to benefit you and be safe for you to take.

8. geneyx.com geneyx.com/blog-archive/pharmacogenomic-testing-can-improve-medication-safety/

How Pharmacogenomic Testing Can Improve Medication ... Discover how pharmacogenetic testing can improve prediction of drug efficacy, adverse reactions and enhance clinical trials. Read on.

9. nature.com nature.com/articles/s41397-024-00350-1

Clinical and economic outcomes of a pharmacogenomics ... Results show pharmacogenomics-enriched comprehensive medication management can favorably impact healthcare utilization in a self-insured employer population.

10. wolterskluwer.com wolterskluwer.com/en/expert-insights/pharmacogenomics-is-improving-patient-safety-and-reducing-costs

Preemptive genetic testing in cardiovascular care Genetic testing for drug effectiveness and safety improves patient outcomes · Applied pharmacogenomic testing can reduce costs · Patients express ...