Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Enrolling by Invitation
NCT Number: NCT07060300
Comprehensive Assessment of Reactions to Pharmacogenetics in Complex Care Patients
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.
Enrolling by Invitation
Interested in participating?
Request InfoKey information
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Agree to Pharmacogenetic Testing
OtherCaregivers agree to receive pharmacogenetic testing for their child.
Primary outcomes
-
Percentage of Caregivers of Medically Complex Patients who accept the offer of Free Clinical Pharmacogenetic Testing
Time frame: Day 1
What portion of caregivers accept pharmacogenetic testing for their children when the barriers of access and financial burden are removed
Secondary outcomes
-
Barriers to acceptance of Pharmacogenetic testing
Time frame: 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
Time frame: 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
Sponsors and collaborators
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Registry information
Acronym: CAREPICC
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Jul 11, 2025
- Registry last updated
- Jul 24, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.