Children and Youth With Medical Complexity
Conditions
Keywords
transition, complex care
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?
Interventions
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.
Sponsors
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
210 Months to 213 Months
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Transfer Completion | 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). |
| 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. |
| Early Identification and Transition Readiness- Self-Care | 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. |
| 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. |
| 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. |
| 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. |
| 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- 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. |
Countries
Canada
Outcome results
None listed