Pediatric Medical Complexity Based on PMCA Score of 3CAREPICCNCT07060300
Comprehensive Assessment of Reactions to Pharmacogenetics in Complex Care Patients
A study testing Agree to Pharmacogenetic Testing in people with Pediatric Medical Complexity Based on PMCA Score of 3, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Medical Complexity Based on PMCA Score of 3
- What is being tested?
- Agree to Pharmacogenetic Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
About this study
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.
Read the 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.
- Being tested
- Agree to Pharmacogenetic Testing
- Keywords
- Medical Compexity, Pharmacogenetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agree to Pharmacogenetic TestingOther
Caregivers agree to receive pharmacogenetic testing for their child.
| Study group | Role | What they receive |
|---|---|---|
| Accept Pharmacogenetic Testing | Experimental | Caregivers who agree to receive Pharmacogenetic testing for their child Receives: Other: Agree to Pharmacogenetic Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (2)
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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start15 Jul 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Medical Complexity Based on PMCA Score of 3Studies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonya Tang Girdwood, Children's Hospital Medical Center, Cincinnati
- Investigators
- Sonya Tang Girdwood, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060300
- Sponsor's protocol ID
- 2025-0139
- Acronym
- CAREPICC
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of Reactions to Pharmacogenetics in Complex Care Patients
- ClinicalTrials.gov ID
- NCT07060300
- Acronym / sponsor ID
- CAREPICC / 2025-0139
- Keywords
- Medical Compexity, Pharmacogenetics
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accept Pharmacogenetic Testing | Experimental | Other: Agree to Pharmacogenetic TestingCaregivers who agree to receive Pharmacogenetic testing for their child |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agree to Pharmacogenetic TestingCaregivers agree to receive pharmacogenetic testing for their child. | Other | Accept Pharmacogenetic Testing |
Primary outcome
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
2 secondary outcomes
Barriers to acceptance of Pharmacogenetic testing
Time frame: 6 months
Facilitators to acceptance of pharmacogenetic testing
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sonya Tang Girdwood principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agree to Pharmacogenetic Testing in people with Pediatric Medical Complexity Based on PMCA Score of 3, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Caregivers of Medically Complex Patients who accept the offer of Free Clinical Pharmacogenetic Testing (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.