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소아과에서 성인 진료로 의료 복잡성이 높은 아동 및 청소년을 위한 집중 전환 촉진 (PITCare)

2026년 11월 5일 업데이트: Eyal Cohen, The Hospital for Sick Children

Medical advances have allowed many more children and youth with medical complexity (CMC) to survive well into adulthood. However, this has not been matched with increases in knowledge of complex conditions or the availability of supports as they transition into the adult care system. The goal of this randomized control trial is to compare intensive transition support from a transition team, led by an advance practice nurse, during transition to adult care for 2 years, with usual care in CMC. Participants assigned to the intervention group will be offered support in care planning, receiving funding, and connecting with a primary care provider and adult subspecialists.

The main questions it aims to answer are:

  1. Does intensive transition support improve the patient's continuity of care over 2 years compared with usual care?
  2. Will there be differences between intervention and control groups with respect to other outcomes related to the youth/family's satisfaction with care, care coordination, self-care, health service utilization, cost-effectiveness, and quality of life?
  3. What are the experiences of youth, parents, the transition team, and other clinicians involved in the intensive transition support process?

연구 개요

연구 유형

중재적

등록 (실제)

144

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

    • Ontario
      • Toronto, Ontario, 캐나다
        • The Hospital for Sick Children

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

17년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Patients 17 years 6 months- 17 years 9 months old (inclusive) who meet Ontario's CMC definition:

    1. technology dependence and/or users of high-intensity care,
    2. fragility (severe and/or life-threatening condition,
    3. chronicity (expected to last at least 6 months),
    4. complexity (involvement of ≥5 healthcare practitioners/teams and healthcare services in ≥ 3 locations such as home, school, hospital, etc.).

Exclusion Criteria:

  • are expected to die within 2 years of recruitment (e.g., those receiving active end-of-life care)
  • do not have a stable primary caregiver (e.g., those who reside in residential or long-term care facilities, and those in foster care as the intervention is focused on a patient-caregiver dyad)

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 간섭

Participants assigned to the intervention arm will transfer their transition support leadership to a transition team composed of a transition navigator (an advance practice nurse), a nurse navigator (a registered nurse) and a social worker over 2 years to support them through the multiple phases of CMC transitions including guidance, monitoring, planning, care transfer and transfer completion. CMC and their caregivers will be offered support in care planning, receiving funding, and connecting with a primary care provider and adult subspecialists.

간섭 없음: Control/ Usual Care

Standard of care in the control group will involve the utilization of existing tools within clinical programs which may include preparation for transitions, but there will be no systematic follow-up by a paediatric provider beyond age 18. Care will be transferred to adult providers (primary care and specialists) via a transition guide that will be offered to participants and their referring providers. This is the current model of care for virtually all CMC in Ontario.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Transfer Completion
기간: 6 to 30 months

Successful transfer of primary and subspecialty care to continuous primary care and a prioritized subspecialty in adult care will be measured using a relational continuity of care measure - the Bice Boxerman Index (modified for the study population).

6 to 30 months

2차 결과 측정

결과 측정
측정값 설명
기간
Transfer Completion
기간: Baseline to 24 months

Successful transfer of primary and subspecialty care to continuous primary care and a prioritized subspecialty in adult care will be measured using a relational continuity of care measure - the Bice Boxerman Index (modified for the study population).

Baseline to 24 months
Transfer Completion
기간: 6 to 30 months

Successful transfer of primary care to continuous adult primary care will be measured using a relational continuity of care measure - the Bice Boxerman Index.

6 to 30 months
Transfer Completion
기간: 6 to 30 months

Successful transfer of subspecialty care to continuous care from a prioritized subspeciality provider in adult care will be measured using a relational continuity of care measure - the Bice Boxerman Index.

6 to 30 months
Transfer Completion
기간: Baseline to 24 months

Successful transfer of subspecialty care to continuous care from all subspecialty providers in adult care will be measured using a relational continuity of care measure - the Bice Boxerman Index.

Baseline to 24 months
Transfer Completion
기간: Baseline to 24 months

The proportion of patients who receive a Bice Boxerman Index score of 0 (< 2 visits to both a subspecialty and primary care provider) will be assessed.

Baseline to 24 months
Transfer Completion
기간: Baseline to 24 months

The proportion of visits to all primary care providers that are made to the usual care provider will be assessed among individuals who had ≥ 3 primary care visits (UPC Index).

Baseline to 24 months
Early Identification and Transition Readiness- Satisfaction with Transitional Healthcare
기간: Baseline, 12 months and 24 months

The change in caregiver satisfaction with transitional health care services will be measured using the Larsen Client Satisfaction Questionnaire (CSQ) (8-item). The change in patient satisfaction will also be measured with the CSQ where able. Comparisons will be made between intervention and control groups.

Baseline, 12 months and 24 months
Early Identification and Transition Readiness- Self-Care
기간: Baseline, 12 months and 24 months

The change in the caregiver's family empowerment status will be measured with the Family Empowerment Scale (24-item). Scoring will be accomplished by summing responses from items within the family (12 items) and service system (12 items) to generate sub-scores. Comparisons will be made between intervention and control groups.

Baseline, 12 months and 24 months
Early Identification and Transition Readiness- Self-Care
기간: Baseline, 12 months and 24 months

The change in the patient's knowledge and confidence in managing their health will be measured (if able) using the Patient Activation Measure (10-item). Comparisons will be made between intervention and control groups.

Baseline, 12 months and 24 months
Information Sharing and Support, Transition Plan and Coordinated Transition
기간: Baseline, 12 months and 24 months

The change in utility of care planning tools, written transition plan assessment, coordination of care among providers and families and, coordination of care between providers and families will be assessed with the Family Experiences with Coordination of Care (FECC) survey, completed by the caregiver. Comparisons will be made between intervention and control groups.

Baseline, 12 months and 24 months
Introduction to Adult Services
기간: 12 months and 24 months

The number of patients who have received (presence or absence) adult-oriented funding and services will be assessed via report by the caregiver or, if able, the youth (e.g., receipt of Ontario Disability Support Program ODSP funding). Comparisons will be made between intervention and control groups.

12 months and 24 months
Use of Services
기간: Baseline to 24 months

Low acuity emergency department visits, emergency department use, hospitalization, technological complications, and immunization will be captured using encoded health administrative data housed at ICES to determine the patient's health care and preventative care use. Comparisons will be made between intervention and control groups.

Baseline to 24 months
Use of Services- Incremental Cost-Utility Ratio (ICUR)
기간: Baseline to 24 months

A probabilistic cost-utility analysis will be conducted using patient-level data, to determine the incremental cost per quality-adjusted life-year gained (QALY) of intensive transition support compared to usual care, from a health system perspective. QALY gains for both patient and caregiver will be included. All direct health care costs and health service utilization will be ascertained from study data linked to administrative datasets at ICES. Utility, determined by mapping patient and caregiver responses to the EQ-5D-5L, will be used to generate QALY gains (or losses) over the time horizon.

Baseline to 24 months
Health-Related Quality of Life
기간: Baseline, 12 months and 24 months

The change in overall health-related quality of life of both the patient and their caregiver will be measured using the EQ-5D-5L. The digit for each of the scale's five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) can be combined into a 5-digit number that describes the patient's health state and is commonly used to estimate health utilities. The descriptive system is complemented by a visual analogue scale where patients record their self-rated health. Comparisons will be made between intervention and control groups.

Baseline, 12 months and 24 months
Health-Related Quality of Life-Caregiver Fatigue
기간: Baseline, 12 months and 24 months

The change in caregiver fatigue will be measured using the PROMIS Fatigue Scale (8-item). The Fatigue scale is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. Each question has five response options ranging in value from one to five. Comparisons will be made between intervention and control groups.

Baseline, 12 months and 24 months
Health-Related Quality of Life- Family Distress
기간: Baseline, 12 months and 24 months

The change in family distress will be assessed using the Brief Family Distress Scale (1-item) completed by the caregiver. The 10-point Likert scale is used to measure crisis level, which is assigned by groupings of the scale continuum, with a level between 1-3 indicating no impairment, 4-5, moderate impairment, and 6-10, marked impairment. Comparisons will be made between intervention and control groups.

Baseline, 12 months and 24 months
Experiences in The Process
기간: 12 to 24 months

Semi-structured qualitative interviews will be conducted with a subset of intervention participants, health care providers, including both pre-transition and post-transition clinicians, and the transition team to gauge their experience with the transition support process.

12 to 24 months

기타 결과 측정

결과 측정
측정값 설명
기간
Implementation Progress Outcomes- Care Planning
기간: Baseline to 24 months

The implementation process will be assessed by determining the fidelity of the intervention using percentages of completion for each of the four main intervention components. The percentage of completed care planning documentation will be captured by the transition team for those participants assigned to the intervention group.

Baseline to 24 months
Implementation Progress Outcomes- Integration with Primary Care Providers
기간: Baseline to 24 months

The implementation process will be assessed by determining the fidelity of the intervention using percentages of completion for each of the four main intervention components. The percentage of primary care visits scheduled and attended by the transition team will be captured by the transition team for those participants assigned to the intervention group.

Baseline to 24 months
Implementation Progress Outcomes- Adult Subspecialty Facilitation
기간: Baseline to 24 months

The implementation process will be assessed by determining the fidelity of the intervention using percentages of completion for each of the four main intervention components. The percentage of joint adult subspecialty visits and visits scheduled and attended by the transition team will be captured by the transition team for those participants assigned to the intervention group.

Baseline to 24 months
Implementation Progress Outcomes- Facilitation of Funding
기간: Baseline to 24 months

The implementation process will be assessed by determining the fidelity of the intervention using percentages of completion for each of the four main intervention components. The percentage of eligible funding applications completed and received will be captured by the transition team for those participants assigned to the intervention group.

Baseline to 24 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

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)

2023년 11월 24일

기본 완료 (실제)

2026년 4월 30일

연구 완료 (실제)

2026년 4월 30일

연구 등록 날짜

최초 제출

2023년 10월 10일

QC 기준을 충족하는 최초 제출

2023년 10월 16일

처음 게시됨 (실제)

2023년 10월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 5일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 1000080621

개별 참가자 데이터(IPD) 계획

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