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Het bevorderen van intensieve transities voor kinderen en jongeren met een medische complexiteit, van kinder- naar volwassenenzorg (PITCare)

5 november 2026 bijgewerkt door: 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?

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

144

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

17 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Interventie

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.

Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Transfer Completion
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Transfer Completion
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Implementation Progress Outcomes- Care Planning
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

24 november 2023

Primaire voltooiing (Werkelijk)

30 april 2026

Studie voltooiing (Werkelijk)

30 april 2026

Studieregistratiedata

Eerst ingediend

10 oktober 2023

Eerst ingediend dat voldeed aan de QC-criteria

16 oktober 2023

Eerst geplaatst (Werkelijk)

23 oktober 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 1000080621

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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