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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

2026年4月29日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

450

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Wisconsin
      • Madison、Wisconsin、アメリカ、53792
        • 募集
        • University of Wisconsin

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
実験的: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.
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Uptake of Assigned Components
時間枠:up to 1 year
Assigned components include: surveys returned, clinic observations completed, and interviews completed.
up to 1 year

二次結果の測定

結果測定
時間枠
Percentage of Participants who withdrawal from the study
時間枠:up to 1 year
up to 1 year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Catherine Allen, MD、UW School of Medicine and Public Health

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年12月1日

一次修了 (推定)

2026年11月30日

研究の完了 (推定)

2026年11月30日

試験登録日

最初に提出

2026年4月23日

QC基準を満たした最初の提出物

2026年4月23日

最初の投稿 (実際)

2026年4月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月5日

QC基準を満たした最後の更新が送信されました

2026年4月29日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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