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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease
• Intervention / Treatment: 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; Other: Participating Provider Interviews and surveys

Detailed Description

While people born with congenital heart disease (CHD) are living longer lives, the CDC estimates that 4 in 10 of those adults have disabilities and worse outcomes than those with heart defects alone. The investigators found that patients with disabilities were also at higher risk of being lost in the transition from pediatric to adult healthcare. Some adolescent patients with CHD and their families fear the transition to adult healthcare more than open heart surgery. Interventions to improve access for these high-risk patients are urgently needed. Additionally, half of patients face disabilities in their lifetime and are more likely to require emergency surgical procedures, be admitted to intensive care, and die prematurely. So, while CHD affects 1% of the population, it represents more than 10% of healthcare expenditures in the United States. This disparity must be addressed to improve healthcare transition for all patients, up to 63% of whom disengage from cardiac care as adults. 83% of CHD patients experience communication, mobility, and psychosocial complications not accounted for in existing transition tools. Accessible care is useable by the greatest number of people but is specifically designed for those with physical, sensory, and cognitive disabilities, and fewer high-risk patients will be lost if the individual, health, and community factors that make care accessible are addressed. Patients find themselves in a disability-health paradox: aging into a system of care not designed for them. Reducing the burden of CHD transition without addressing disability reinforces outcome disparities.

This study involves:

• On-Study Procedures

  • participants will be asked their preference for contact for relevant follow-up (text, phone, email)
  • Both patients and providers may receive a copy of the QPL and aTRA prior to their clinic visit. All enrolled consenting patients may be observed during their clinic visit by a member of the study team.
  • Accessible Care Model Visit: Accessible care activities will be performed by the provider following the patient participants enrollment in the study and may be observed by study staff.
  • The goal is to use areas of strength, and allow youth to prioritize areas of interest, to generate action toward transition from pediatric to adult healthcare by age 26, a period when most healthcare and insurance systems require transition. Once the patient has completed their portion, the provider completes 6 items in the aTRA.
  • Data on care processes will be abstracted from the participant's medical records or the observation
  • Participants will be interviewed after the clinic visit.

• Adaptive Transition Education Procedures

  • Recruitment Interviews (3-10 patient participants plus their providers to complete 30-60 minute interviews)
  • Identification and adaptive transition education activities will take place within approximately a month of the study wave and the knowledge gained will help to improve subsequent study waves
  • Participating Patient-Support Person Interviews - Patients, and their support person if present, may complete a 30-60 minute structured or unstructured interviews following the education session in a clinical encounter.
  • The first 5 dyadic interviews will be analyzed to refocus interview questions and conduct additional interviews until saturation over the three phases of the study.
  • Participating Patient-Support Person Surveys - 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 (about 10% of enrolled patients).
  • Participating Provider Interviews and surveys - Before the end of each wave, a brief (15-20 minute) unstructured interview will be conducted with the healthcare team

• Unstructured and semi-structured interviews

  • Semi-structured interviewing is based on the use of an interview guide which is revised over the course of the study.
  • 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.

• Clinical Database Review

  • The clinical database is the Clinical Database for Adolescents in Transition of Care Education was created in 2020 when the program initiated as a quality improvement effort to prevent youth from dropping out of care in adulthood. Records contained go back to 1995 and are prospectively added. It's purpose is to support a QI/QA project to monitor and improve the transition of pediatric CHD patients to adult care.

Study Aims:

• Aim 1: Maximize feasibility of adopting, and acceptability of implementing, the accessible healthcare model, Accessible Congenital Heart Disease Survivor Transition Readiness For Long-Term Health (ACHD STRONG), for providers. Determine which team members best support transition education and optimize their input and involvement.
• Aim 2: Test the model among diverse patients and families to iteratively co-design accessible care. Work with our community partners, patients, and families to revise our toolkit and implementation plan.

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Allen, MD; Phone Number: (608) 263-9783; Email: ccallen@pediatrics.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients; Diagnosed CHD patients between the ages of 12-26 years.	Other: Accessible Care Model Visit; Accessible care activities will be performed by the provider following the patient participants enrollment in the study and may be observed by study staff.; Other: Recruitment Interviews; A subset of 3-10 patient participants (plus their health care providers) who consent to be reapproached will complete 30-60 minute recruitment interviews.; Other: Participating Patient-Support Person Interviews; 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.; Other: Participating Patient-Support Person Surveys; 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.; Other: Unstructured and semi-structured interviews; 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.
Experimental: Patient Support People	Other: Participating Patient-Support Person Interviews; 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.; Other: Participating Patient-Support Person Surveys; 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.; Other: Unstructured and semi-structured interviews; 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.
Experimental: Patient Health Care Providers	Other: Unstructured and semi-structured interviews; 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.; Other: Participating Provider Interviews and surveys; Before the end of each wave, a brief (15-20 minute) unstructured interview with the healthcare team will be conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Uptake of Assigned Components	Assigned components include: surveys returned, clinic observations completed, and interviews completed.	up to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants who withdrawal from the study	up to 1 year

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Catherine Allen, MD, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pediatric; healthcare; transition to adult care; RE-AIM; improve care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 2024-0450; Protocol Version 4/3/26 (Other Identifier: UW Madison); SMPH | Pediatrics - Cardiology (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No