Comprehensive Assessment of Reactions to Pharmacogenetics... | NCT07060300

Studies
Comprehensive Assessment of Reactions to Pharmacogenetics in Complex Care Patients

NCT07060300

Sponsor

Children's Hospital Medical Center, Cincinnati

Status

Enrolling by invitation

Last Update Posted

Jul 24, 2025Actual

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Pediatric Medical Complexity Based on PMCA Score of 3

Interventions

Agree to Pharmacogenetic Testing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2025Actual

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Jun 30, 2028Estimated

First Submitted Date

Jun 3, 2025

First Submission Date that Met QC Criteria

Jul 1, 2025

First Posted Date

Jul 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2025

Last Update Posted Date

Jul 24, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sonya Tang Girdwood, Associate Professor of Pediatrics, Children's Hospital Medical Center, CincinnatiPrincipal Investigator

Lead Sponsor

Children's Hospital Medical Center, CincinnatiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

With financial and access barriers removed, do caregivers of complex care patients agree to receive Pharmacogenetic testing for their children?
With financial and access barriers removed, what are some remaining barriers to implementation of pharmacogenetics testing?
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Accept Pharmacogenetic Testing	Experimental	Caregivers who agree to receive Pharmacogenetic testing for their child	Other: Agree to Pharmacogenetic Testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Agree to Pharmacogenetic Testing	Other	Caregivers agree to receive pharmacogenetic testing for their child.	Accept Pharmacogenetic Testing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Day 1

Secondary Outcomes

Measure	Description	Time Frame
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	6 months

Other Outcomes

Not provided

Eligibility Module

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
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sonya Tang Girdwood	Children's Hospital Medical Center, Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital		Cincinnati	Ohio	45229	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided