Promoting Intensive Transitions for Children and Youth With Medical Complexity From Pediatric to Adult Care
- Conditions
- Children and Youth With Medical Complexity
- Interventions
- Other: Intensive Transition Support
- Registration Number
- NCT06093386
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
-
Patients 17 years 6 months- 17 years 9 months old (inclusive) who meet Ontario's CMC definition:
- technology dependence and/or users of high-intensity care,
- fragility (severe and/or life-threatening condition,
- chronicity (expected to last at least 6 months),
- complexity (involvement of ≥5 healthcare practitioners/teams and healthcare services in ≥ 3 locations such as home, school, hospital, etc.).
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Intensive Transition Support -
- Primary Outcome Measures
Name Time Method Transfer Completion 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).
- Secondary Outcome Measures
Name Time Method Early Identification and Transition Readiness- Satisfaction with Transitional Healthcare 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.
Information Sharing and Support, Transition Plan and Coordinated Transition 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.
Introduction to Adult Services 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.
Use of Services 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.
Health-Related Quality of Life- Family Distress 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.
Experiences in The Process 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.
Transfer Completion 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).
Early Identification and Transition Readiness- Self-Care Baseline 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.
Health-Related Quality of Life-Caregiver Fatigue 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.
Health-Related Quality of Life 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.
Use of Services- Incremental Cost-Utility Ratio (ICUR) 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.
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada