Comprehensive Assessment of Reactions to Pharmacogenetics in Complex Care Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Agree to Pharmacogenetic Testing.
- Who it may be relevant to
- Registry conditions: Pediatric Medical Complexity Based on PMCA Score of 3. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Agree to Pharmacogenetic Testing
Caregivers agree to receive pharmacogenetic testing for their child.
Primary outcome measures
- Percentage of Caregivers of Medically Complex Patients who accept the offer of Free Clinical Pharmacogenetic Testing [Time frame: Day 1]
Secondary outcome measures (2)
- Barriers to acceptance of Pharmacogenetic testing [Time frame: 6 months]
- Facilitators to acceptance of pharmacogenetic testing [Time frame: 6 months]
Eligibility criteria
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
- Patients attending the Cincinnati Children's Hospital Complex Care Clinic for chronic care management visits
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Cincinnati Children's Hospital — Cincinnati
Identifiers
NCT: NCT07060300 · 2025-0139