Accessible care model comparing nurse-led versus physician-led transition education for teens and young adults with congenital heart disease
Implementation of an Accessible Healthcare Model (ACHD STRONG): Comparing Nurse and Physician Lead Healthcare Transition Education in a RE-AIM Framework
NA · University of Wisconsin, Madison · NCT07559253
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 12 Years to 26 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison (other) |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT07559253 on ClinicalTrials.gov |
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).
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Madison, Wisconsin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Heart Disease, healthcare, transition to adult care, improve care, pediatric, RE-AIM