Clinical trial NCT05849285: Evaluation of the Transitional and Lifelong Care Program
Official title: Evaluating a Model of Transitional and Lifelong Care for Adults With Childhood-Onset Disabilities
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Spina Bifida
Developmental Disability
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 410
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be categorized into two cohorts: 1) patients of the TLC program, 2) controls . Participant dyads will be formed that include the adult patient (and a caregiver, spouse, or support person that may be involved in the patient's care. TLC dyads will be recruited from the existing client base of the program and control dyads will be recruited from the Kitchener/Waterloo/Cambridge area of Ontario (and the surrounding rural areas).

Brief summary: The population cared for in the Transitional and Lifelong Care (TLC) clinic is youth and adults with childhood-onset disability, of which the large majority are adults with brain-based, neurodevelopmental conditions such as cerebral palsy, spina bifida and developmental disability. The TLC program was created to address the health inequities that have long existed for this population because of the gaps in care they experience once they transition from pediatric healthcare services to the adult healthcare sector. The TLC program offers coordinated and comprehensive management of co-occurring mental, social and physical health conditions for this group of adults with neurodiverse conditions. The proposed study will provide much needed evaluation of the TLC model as an intervention to provide transitional and lifelong care that reduces the barriers experienced because of the undefined clinic path - potentially more appropriately referred to as a "cliff" by a Freeman et al., (2015) - for these individuals. With appropriate evidence of effectiveness, scaling of the TLC program to other Ontario Health regions and more widely across Canada would improve access healthcare providers who are knowledgeable and competent in the management of physical and mental health conditions for adults with neurodiverse conditions as well as service integration and coordination between social and health sectors. The TLC clinic was co-designed with adults with neurodiverse conditions and health care providers in 2014 and represents a significant and sustainable change in the way healthcare has been delivered for this population in the Ontario Health West region over the last 7 years. More than 750 people have accessed coordinated and comprehensive care from Physiatrists, a Nurse Practitioner, Social Worker, Physiotherapist, Occupational Therapist, Speech Language Pathologist, Registered Dietitian and Rehabilitation Therapist in the TLC program since it began, documenting the effectiveness of this care has the power to re-shape care received for adults with neurodiverse conditions that onset in childhood in Canada.


Eligibility criteria: Inclusion Criteria:

Each participant dyad will consist of one person, of either sex and gender, who is over the age of 21 years with a childhood-onset disability, and the primary caregiver (based on contact hours) or support person, of either sex and gender, involved in their care. In cases where the patient participant is independent with care, a spouse or family member may still participate in the caregiver portion of the study.

2. Patient participants will have continuously resided in Ontario during the years of 2015 to 2020 to facilitate full data retrieval from the administrative dataset.

3. Healthcare providers, of any discipline, who provide care to adults with childhood-onset conditions in the TLC program.

Exclusion Criteria:

Patient participants will be ineligible if they are in a phase of deterioration associated with a progressive health condition identified either personally or by the caregiver participant.

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Year 1
Secondary outcomes:
measure: Health Related Quality of Life (General)
timeFrame: Year 1
measure: Health Related Quality of Life (WHO)
timeFrame: Year 1
measure: Caregiver Burden
timeFrame: Year 1
measure: Perceived Support of Healthcare Providers
timeFrame: Year 1
measure: Economic Analysis
timeFrame: Year 2
Other outcomes:
Locations:
city: London
country: Canada
facility: Parkwood Institute
state: Ontario
Study officials:
affiliation: Western University
name: Laura K Brunton, PhD
role: PRINCIPAL_INVESTIGATOR
References: