Comprehensive Assessment of Reactions to Pharmacogenetics in Complex Care Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pediatric Medical Complexity Based on PMCA Score of 3

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Accept Pharmacogenetic Testing

Caregivers who agree to receive Pharmacogenetic testing for their child

Group Type EXPERIMENTAL

Agree to Pharmacogenetic Testing

Intervention Type OTHER

Caregivers agree to receive pharmacogenetic testing for their child.

Interventions

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Agree to Pharmacogenetic Testing

Caregivers agree to receive pharmacogenetic testing for their child.

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No