An interventional study of Agree to Pharmacogenetic Testing in Pediatric Medical Complexity Based on PMCA Score of 3, sponsored by Children's Hospital Medical Center, Cincinnati. Enrolling by invitation at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Health services research
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:
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.
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.
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients whose primary care providers are those at the Cincinnati Children's Complex Care Clinic
Exclusion Criteria:
Caregivers who agree to receive Pharmacogenetic testing for their child
Other: Agree to Pharmacogenetic Testing
Caregivers agree to receive pharmacogenetic testing for their child.
Percentage of Caregivers of Medically Complex Patients who accept the offer of Free Clinical Pharmacogenetic Testing
What portion of caregivers accept pharmacogenetic testing for their children when the barriers of access and financial burden are removed
Time frame: Day 1
Barriers to acceptance of Pharmacogenetic testing
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
Time frame: 6 months
Facilitators to acceptance of pharmacogenetic testing
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
Time frame: 6 months
Plan to share: No — No specific Identifiable Patient Health Information (PHI) will be shared. However, aggregated data and de-identified info may be shared with IRB pre-approved collaborators.
No publications or documents are linked to this record.
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Children's Hospital Medical Center, Cincinnati