Comprehensive Assessment of Reactions to Pharmacogenetics in Complex Care Patients

Not Applicable

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

• Registration Number: NCT07060300
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-06-03
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-01
• Study First Posted: 2025-07-11
• Last Update Submitted: 2025-07-14
• Study Start: 2025-07-15
• Last Update Posted: 2025-07-17
• Primary Completion: 2027-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Caregivers of Medically Complex Patients who accept the offer of Free Clinical Pharmacogenetic Testing	Day 1	What portion of caregivers accept pharmacogenetic testing for their children when the barriers of access and financial burden are removed

Secondary Outcome Measures

Name	Time	Method
Barriers to acceptance of Pharmacogenetic testing	6 months	Barriers will be elicited through semi-structured interviews on consenting caregivers. We will utilize thematic analysis to identify and assess potential remaining barriers other than cost and access that inhibit the feasibility of pharmacogenetic testing in patients with medical complexity
Facilitators to acceptance of pharmacogenetic testing	6 months	Facilitators will be elicited through semi-structured interviews on consenting caregivers. We will utilize thematic analysis to identify and assess facilitators that enhance the feasibility of pharmacogenetic testing in patients with medical complexity

Trial Locations

Locations (1)

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States