이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 4월 29일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

450

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Wisconsin
      • Madison, Wisconsin, 미국, 53792
        • 모병
        • University of Wisconsin

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
실험적: 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.
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Uptake of Assigned Components
기간: up to 1 year
Assigned components include: surveys returned, clinic observations completed, and interviews completed.
up to 1 year

2차 결과 측정

결과 측정
기간
Percentage of Participants who withdrawal from the study
기간: up to 1 year
up to 1 year

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Catherine Allen, MD, UW School of Medicine and Public Health

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 12월 1일

기본 완료 (추정된)

2026년 11월 30일

연구 완료 (추정된)

2026년 11월 30일

연구 등록 날짜

최초 제출

2026년 4월 23일

QC 기준을 충족하는 최초 제출

2026년 4월 23일

처음 게시됨 (실제)

2026년 4월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 29일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

선천성 심장 질환에 대한 임상 시험

Accessible Care Model Visit에 대한 임상 시험

구독하다