Accessible care model comparing nurse-led versus physician-led transition education for teens and young adults with congenital heart disease
Official title: Implementation of an Accessible Healthcare Model (ACHD STRONG): Comparing Nurse and Physician Lead Healthcare Transition Education in a RE-AIM Framework
Run by University of Wisconsin, Madison · NCT07559253 · Data updated 2026-11-12
This project will test whether an accessible care model and nurse-led versus physician-led transition education helps teens and young adults (ages 12–26) with congenital heart disease move successfully from pediatric to adult heart care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 26 Years |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT07559253 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adolescents and young adults aged 12–26 with congenital heart disease preparing to transition from pediatric to adult care, able to participate in English or Spanish, including those who self-identify or are documented as having disabilities.
✕Probably not a fit
Patients who are already well connected with adult congenital cardiology services, cannot participate in English or Spanish, or whose provider declines their participation are unlikely to gain additional benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Up to 200 patients with congenital heart disease, their support persons, and their providers will be enrolled at the University of Wisconsin–Madison to compare an accessible care visit plus transition education led by nurses versus physicians. The study uses the RE-AIM framework to measure reach, effectiveness, adoption, implementation, and maintenance and collects data via visits, interviews, and surveys from patients, support people, and providers. A subset of participants who self-identify or have documented disabilities will be included to test accessibility features aimed at reducing loss to follow-up during transition. Activities are conducted in English or Spanish and require assent/consent from participants (with parental consent for minors).
Why it matters
Potential benefit: If successful, the intervention could help more young people with CHD — especially those with disabilities — find and stay connected to adult heart care and reduce gaps that lead to worse outcomes.
How similar studies have gone: Nurse-led transition programs and RE-AIM–guided implementation approaches have shown promising but varied results in other chronic conditions, while an explicit accessible-care focus for CHD populations with disabilities is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria (Patient Participants): * Diagnosed CHD patients between the ages of 12-26 will be eligible * Able to provide assent when seen by a pediatric or adult congenital cardiologist provider. * A subset of patients will self-identify as having a disability, and or, be identified with disabilities in their medical or educational records. * Participants to provide assent/consent and complete all study activities in English or Spanish * Participants under the age of 18 must have a legal guardian who is able to provide consent in English or Spanish. Exclusion Criteria: * Providers may decline participation of any patient at their clinical discretion
Where it's running
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University of Wisconsin
Madison, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Catherine Allen, MD — UW School of Medicine and Public Health
- Study coordinator: Catherine Allen, MD
- Email: ccallen@pediatrics.wisc.edu
- Phone: (608) 263-9783
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.