Children and Youth With Medical ComplexityPITCareNCT06093386
Promoting Intensive Transitions for Children and Youth With Medical Complexity From Pediatric to Adult Care
A study testing Intensive Transition Support in people with Children and Youth With Medical Complexity, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 210 to 213 months
- Conditions the study is for
- Children and Youth With Medical Complexity
- What is being tested?
- Intensive Transition Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteCanada
- Study dates
- 24 Nov 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 210 to 213 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Does intensive transition support improve the patient's continuity of care over 2 years compared with usual care?
- 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?
- What are the experiences of youth, parents, the transition team, and other clinicians involved in the intensive transition support process?
- Being tested
- Intensive Transition Support
- Keywords
- transition, complex care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Transition SupportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Intensive Transition Support |
| Control/ Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfer Completion
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).
Measured: 6 to 30 months
Secondary outcomes (17)
Transfer Completion
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).
Measured: Baseline to 24 months
Transfer Completion
Successful transfer of primary care to continuous adult primary care will be measured using a relational continuity of care measure - the Bice Boxerman Index.
Measured: 6 to 30 months
Transfer Completion
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.
Measured: 6 to 30 months
Transfer Completion
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.
Measured: Baseline to 24 months
Transfer Completion
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.
Measured: Baseline to 24 months
Transfer Completion
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).
Measured: Baseline to 24 months
Early Identification and Transition Readiness- Satisfaction with Transitional Healthcare
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.
Measured: Baseline, 12 months and 24 months
Early Identification and Transition Readiness- Self-Care
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.
Measured: Baseline, 12 months and 24 months
Early Identification and Transition Readiness- Self-Care
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.
Measured: Baseline
Information Sharing and Support, Transition Plan and Coordinated Transition
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.
Measured: Baseline, 12 months and 24 months
Introduction to Adult Services
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.
Measured: 24 months
Use of Services
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.
Measured: Baseline to 24 months
Use of Services- Incremental Cost-Utility Ratio (ICUR)
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.
Measured: Baseline to 24 months
Health-Related Quality of Life
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.
Measured: Baseline, 12 months and 24 months
Health-Related Quality of Life-Caregiver Fatigue
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.
Measured: Baseline, 12 months and 24 months
Health-Related Quality of Life- Family Distress
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.
Measured: Baseline, 12 months and 24 months
Experiences in The Process
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.
Measured: 12 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start24 Nov 2023
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Children and Youth With Medical ComplexityStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Eyal Cohen, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093386
- Sponsor's protocol ID
- 1000080621
- Acronym
- PITCare
- Status last verified
- Aug 2026
- First submitted
- 10 Oct 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santos S, Thomson D, Diaz S, Soscia J, Adams S, Amin R, Bernstein S, Blais B, Bruno N, Colapinto K, Espin S, Fayed N, Greenaway J, Henze M, Ivers NM, LeGrow K, Lim A, Lippett R, Lunsky Y, Macarthur C, Mahant S, Malecki S, Miranda S, Moharir M, Moretti ME, Phillips L, Robeson P, Taryan M, Thorpe K, Toulany A, Vandepoele E, Weitzner B, Orkin J, Cohen E. Promoting Intensive Transitions for Children and Youth with Medical Complexity from Paediatric to Adult Care: the PITCare study-protocol for a randomised controlled trial. BMJ Open. 2024 Dec 9;14(12):e086088. doi: 10.1136/bmjopen-2024-086088.
PubMed 39653557
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Intensive Transitions for Children and Youth With Medical Complexity From Pediatric to Adult Care
- ClinicalTrials.gov ID
- NCT06093386
- Acronym / sponsor ID
- PITCare / 1000080621
- Keywords
- transition, complex care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does intensive transition support improve the patient's continuity of care over 2 years compared with usual care?
- 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?
- What are the experiences of youth, parents, the transition team, and other clinicians involved in the intensive transition support process?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Intensive Transition Support |
| Control/ Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 210 to 213 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients 17 years 6 months- 17 years 9 months old (inclusive) who meet Ontario's CMC definition:
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Transition SupportParticipants 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. | Other | Intervention |
Primary outcome
Transfer Completion
Time frame: 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).
17 secondary outcomes
Transfer Completion
Time frame: Baseline to 24 months
Transfer Completion
Time frame: 6 to 30 months
Transfer Completion
Time frame: 6 to 30 months
Transfer Completion
Time frame: Baseline to 24 months
Transfer Completion
Time frame: Baseline to 24 months
Transfer Completion
Time frame: Baseline to 24 months
Early Identification and Transition Readiness- Satisfaction with Transitional Healthcare
Time frame: Baseline, 12 months and 24 months
Early Identification and Transition Readiness- Self-Care
Time frame: Baseline, 12 months and 24 months
Early Identification and Transition Readiness- Self-Care
Time frame: Baseline
Information Sharing and Support, Transition Plan and Coordinated Transition
Time frame: Baseline, 12 months and 24 months
Introduction to Adult Services
Time frame: 24 months
Use of Services
Time frame: Baseline to 24 months
Use of Services- Incremental Cost-Utility Ratio (ICUR)
Time frame: Baseline to 24 months
Health-Related Quality of Life
Time frame: Baseline, 12 months and 24 months
Health-Related Quality of Life-Caregiver Fatigue
Time frame: Baseline, 12 months and 24 months
Health-Related Quality of Life- Family Distress
Time frame: Baseline, 12 months and 24 months
Experiences in The Process
Time frame: 12 to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Derived from this study: PubMed 39653557Santos S, Thomson D, Diaz S, Soscia J, Adams S, Amin R, Bernstein S, Blais B, Bruno N, Colapinto K, Espin S, Fayed N, Greenaway J, Henze M, Ivers NM, LeGrow K, Lim A, Lippett R, Lunsky Y, Macarthur C, Mahant S, Malecki S, Miranda S, Moharir M, Moretti ME, Phillips L, Robeson P, Taryan M, Thorpe K, Toulany A, Vandepoele E, Weitzner B, Orkin J, Cohen E. Promoting Intensive Transitions for Children and Youth with Medical Complexity from Paediatric to Adult Care: the PITCare study-protocol for a randomised controlled trial. BMJ Open. 2024 Dec 9;14(12):e086088. doi: 10.1136/bmjopen-2024-086088.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Transition Support in people with Children and Youth With Medical Complexity, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfer Completion (time frame: 6 to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06093386, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.