Implementation of an Accessible Healthcare Model (ACHD STRONG): Comparing Nurse and Physician Lead Healthcare Transition Education in a RE-AIM Framework

NCT07559253 | Recruiting

• 3 other identifiers: 2024-0450Protocol Version 4/3/26SMPH | Pediatrics - Cardiology
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The study includes patients with congenital heart disease (CHD), as well as their support persons and their providers, who are preparing to make the transition from pediatric to adult care for their CHD. The purpose of this study is to improve the tools available to help find doctors as patients enter adulthood. 200 people with CHD and support people will be enrolled.

Conditions

Congenital Heart Disease

Keywords

healthcare; transition to adult care; improve care; pediatric; RE-AIM

Outcome Measures

Primary Outcomes (1)

• Percentage of Uptake of Assigned Components

  Assigned components include: surveys returned, clinic observations completed, and interviews completed.

  up to 1 year

Secondary Outcomes (1)

• Percentage of Participants who withdrawal from the study

  up to 1 year

Study Arms (3)

Patients

EXPERIMENTAL

Diagnosed CHD patients between the ages of 12-26 years.

Other: Accessible Care Model Visit; Other: Recruitment Interviews; Other: Participating Patient-Support Person Interviews; Other: Participating Patient-Support Person Surveys; Other: Unstructured and semi-structured interviews

Patient Support People

EXPERIMENTAL

Other: Participating Patient-Support Person Interviews; Other: Participating Patient-Support Person Surveys; Other: Unstructured and semi-structured interviews

Patient Health Care Providers

EXPERIMENTAL

Other: Participating Provider Interviews and surveys; Other: Unstructured and semi-structured interviews

Interventions

Accessible Care Model Visit OTHER

Accessible care activities will be performed by the provider following the patient participants enrollment in the study and may be observed by study staff.

Patients

Recruitment Interviews OTHER

A subset of 3-10 patient participants (plus their health care providers) who consent to be reapproached will complete 30-60 minute recruitment interviews.

Patients

Participating Patient-Support Person Interviews OTHER

Patients, and their support person if present, may complete a 30-60 minute structured or unstructured interviews following the education session in a standard clinical encounter. Dyadic interviews will be analyzed 5 at a time over three phases of study until saturation.

Patient Support People; Patients

Participating Patient-Support Person Surveys OTHER

Participants will complete a survey led by the study team member to identify factors hypothesized to affect transition including age, ethnicity, race, education, transportation, distance from home to clinic, other children at home, plans for care in the transition from pediatric to adult care.

Patient Support People; Patients

Participating Provider Interviews and surveys OTHER

Before the end of each wave, a brief (15-20 minute) unstructured interview with the healthcare team will be conducted.

Patient Health Care Providers

Unstructured and semi-structured interviews OTHER

Semi-structured interviewing is based on the use of an interview guide. Unstructured interviewing is used both as a form of primary data collection and to develop semi-structured interview or survey questions. It is particularly useful know about the lived experience of a participant. In this case, their experiences of transition education and of the clinical encounter.

Patient Health Care Providers; Patient Support People; Patients

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Providers may decline participation of any patient at their clinical discretion

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Catherine Allen, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Allen, MD

CONTACT

(608) 263-9783; ccallen@pediatrics.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)