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

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07559253
Status
Recruiting
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Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
12 Years - 26 Years
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
450 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Patients
    Diagnosed CHD patients between the ages of 12-26 years.
  • Experimental: Patient Support People
  • Experimental: Patient Health Care Providers

Primary Outcome Measure

Percentage of Uptake of Assigned Components [ Time Frame: up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53792-

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By research site
University of Wisconsin· Madison, WI

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