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

29 de abril de 2026 actualizado por: University of Wisconsin, Madison
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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

450

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53792
        • Reclutamiento
        • University of Wisconsin

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Patients
Diagnosed CHD patients between the ages of 12-26 years.
Accessible care activities will be performed by the provider following the patient participants enrollment in the study and may be observed by study staff.
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, 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.
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.
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
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.
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.
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
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.
Before the end of each wave, a brief (15-20 minute) unstructured interview with the healthcare team will be conducted.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Uptake of Assigned Components
Periodo de tiempo: up to 1 year
Assigned components include: surveys returned, clinic observations completed, and interviews completed.
up to 1 year

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Percentage of Participants who withdrawal from the study
Periodo de tiempo: up to 1 year
up to 1 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Catherine Allen, MD, UW School of Medicine and Public Health

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de diciembre de 2025

Finalización primaria (Estimado)

30 de noviembre de 2026

Finalización del estudio (Estimado)

30 de noviembre de 2026

Fechas de registro del estudio

Enviado por primera vez

23 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de abril de 2026

Publicado por primera vez (Actual)

30 de abril de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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