CHILD-BRIGHT READYorNot Brain-Based Disabilities Trial: protocol of a randomised controlled trial (RCT) investigating the effectiveness of a patient-facing e-health intervention designed to enhance healthcare transition readiness in youth
,
Shelley Doucet,
Sarah Gander,
Lehana Thabane,
Sarah Zaidi,
Andrew Mackie,
Roger Stoddard,
Myla E Moretti,
Rima Azar,
Jan Willem Gorter,
Lonnie Zwaigenbaum,
Wendy J Ungar,
Khush Amaria,
Adrienne Kovacs,
Ronen Rozenblum,
Barbara Galuppi,
Linda Nguyen,
Sonya Strohm,
Nadilein Mahlberg,
Alicia Via-Dufresne Ley,
Ariane Marelli,
Donna Thomson,
JoAnne Mosel,
Connie Putterman,
Kinga Pozniak,
Nathan Tasker,
Julia Hanes,
Kyle Chambers,
Jessica Havens,
Claire Dawe-McCord,
Dana Arafeh,
Hana Alazem,
John Andersen,
Kerry Boyd,
Caitlin Cassidy,
Jamie Churchill,
CJ Curran,
Anne Fournier,
Anna McCormick,
Ronit Mesterman,
Maryam Oskoui,
Janet Rennick,
Jordan Sheriko,
Kathy Speechley,
Kelly Wynne,
Fabiola Breault,
Yomna Elshamy,
Rocio Gutierrez,
Hashaam Hasan,
Rhiannon Hicks,
André Pépin,
Rochelle Sorzano,
Jennifer Zwicker
Affiliations
4Association of British Neurologists
Shelley Doucet
University of New Brunswick, Saint John, New Brunswick, Canada
Sarah Gander
Lehana Thabane
3 Biostatistics, St Joseph’s Healthcare, Hamilton, Ontario, Canada
Sarah Zaidi
Andrew Mackie
Roger Stoddard
Myla E Moretti
Ontario Child Health Support Unit and the Clinical Trials Unit, Hospital for Sick Children, Toronto, Ontario, Canada
Rima Azar
Psychobiology of Stress and Health Lab, Psychology Department, Mount Allison University, Sackville, New Brunswick, Canada
Jan Willem Gorter
CanChild Centre for Childhood Disability Research, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada
Lonnie Zwaigenbaum
4 Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada
Wendy J Ungar
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
Khush Amaria
CBT Associates of Toronto Cognitive Behavioural Therapy Services, Toronto, Ontario, Canada
Adrienne Kovacs
Knight Cardiovascular Institute, Oregon Health & Science Univeristy, Portland, Oregon, USA
Ronen Rozenblum
Harvard Medical School, Boston, Massachusetts, USA
Barbara Galuppi
CanChild, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada
Linda Nguyen
School of Rehabilitation Science and CanChild Centre for Childhood Disability Research, McMaster University, Hamilton, Ontario, Canada
Sonya Strohm
CanChild, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada
Nadilein Mahlberg
CanChild, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada
Alicia Via-Dufresne Ley
The Research Institute of the McGill University Health Centre (RI-MUHC), Montreal, Quebec, Canada
Ariane Marelli
Department of Medicine, Faculty of Medicine, McGill University, Montreal, Quebec, Canada
Donna Thomson
JoAnne Mosel
Strategy for Patient-Oriented Research-Evidence Alliance, Toronto, Ontario, Canada
Introduction Youth with brain-based disabilities (BBDs), as well as their parents/caregivers, often feel ill-prepared for the transfer from paediatric to adult healthcare services. To address this pressing issue, we developed the MyREADY TransitionTM BBD App, a patient-facing e-health intervention. The primary aim of this randomised controlled trial (RCT) was to determine whether the App will result in greater transition readiness compared with usual care for youth with BBD. Secondary aims included exploring the contextual experiences of youth using the App, as well as the interactive processes of youth, their parents/caregivers and healthcare providers around use of the intervention.Methods and analysis We aimed to randomise 264 youth with BBD between 15 and 17 years of age, to receive existing services/usual care (control group) or to receive usual care along with the App (intervention group). Our recruitment strategy includes remote and virtual options in response to the current requirements for physical distancing due to the COVID-19 pandemic. We will use an embedded experimental model design which involves embedding a qualitative study within a RCT. The Transition Readiness Assessment Questionnaire will be administered as the primary outcome measure. Analysis of covariance will be used to compare change in the two groups on the primary outcome measure; analysis will be intention-to-treat. Interviews will be conducted with subsets of youth in the intervention group, as well as parents/caregivers and healthcare providers.Ethics and dissemination The study has been approved by the research ethics board of each participating site in four different regions in Canada. We will leverage our patient and family partnerships to find novel dissemination strategies. Study findings will be shared with the academic and stakeholder community, including dissemination of teaching and training tools through patient associations, and patient and family advocacy groups.Trial registration number NCT03852550.
