Comprehensive Assessment of Reactions to Pharmacogenetics in Complex Care Patients (CAREPICC)

Cincinnati Children's Hospital Medical Center

Status: Not yet enrolling

Conditions: Pediatric Medical Complexity, as Determined by the Pediatric Medical Complexity Algorithm (PMCA)

Treatments: Other: Agree to Pharmacogenetic Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT07060300

2025-0139

Details and patient eligibility

About

The goal of this clinical trial is to determine the feasibility and acceptability of Pharmacogenetic Testing, and the attitudes towards the same in caregivers of complex care patients in Cincinnati, OH. The main question[s] it aims to answer are:

1. With financial and access barriers removed, do caregivers of complex care patients agree to receive Pharmacogenetic testing for their children?
2. With financial and access barriers removed, what are some remaining barriers to implementation of pharmacogenetics testing?
3. What are the prevailing attitudes towards Pharmacogenetic testing in the complex care population?

Participants will be offered pharmacogenetic testing for their child free of charge, and will be asked to fill out a voluntary survey. Certain caregivers of complex care patients may be asked if they want to participate in a short semi-structured interview.

Full description

Through this research, the investigators expect to have successfully provided pharmacogenetic testing to a large cohort of patients in Cincinnati Children's Complex Care Clinic, allowing for an improved understanding of how to provide pharmacogenetic testing in children with medical complexity (feasibility) and of caregiver attitudes about pharmacogenetic testing for their children (acceptability). The knowledge gained from this study will be used to inform future program implementations in children with medical complexity (CMC) populations. Successfully tested patients will also provide for future studies to measure the effectiveness of pharmacogenetic testing in this population, as well as prescriber behavior when provided pharmacogenetic testing results.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who score a 3 on the Pediatric Medical Complexity Algorithm

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

   1. Patients attending the Cincinnati Children's Hospital Complex Care Clinic for well child visit
   2. Patients attending the Cincinnati Children's Hospital Complex Care Clinic for chronic care management visits
   3. Legal Guardian is present at time of clinical visit

Exclusion criteria

• Patients attending the Complex Care Clinic for acute illness.
• Patients who have previously received Pharmacogenetic Testing.
• Patients deemed ineligible for approach by the clinical team.
• Patients who are wards of the state.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Accept Pharmacogenetic Testing

Experimental group

Description:

Caregivers who agree to receive Pharmacogenetic testing for their child

Treatment:

Other: Agree to Pharmacogenetic Testing