Promoting Intensive Transitions for Children and Youth with Medical Complexity from Paediatric to Adult Care: the PITCare study—protocol for a randomised controlled trial

Introduction Children with medical complexity (CMC) have chronic, intensive care needs managed by many healthcare practitioners. Medical advances have enabled CMC to survive well into adulthood. However, the availability of supports as CMC transition into the adult care system remain suboptimal, con...

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Main Authors: Noah M Ivers, Sanjay Mahant, Sara Santos, Colin Macarthur, Kevin Thorpe, Julia Orkin, Nora Fayed, Audrey Lim, Myla E Moretti, Joanna Soscia, Eyal Cohen, Lacey Phillips, Sherry Espin, Reshma Amin, Donna Thomson, Alene Toulany, Yona Lunsky, Sanober Diaz, Megan Henze, Sherri Adams, Stacey Bernstein, Brenda Blais, Natasha Bruno, Kimberly Colapinto, Jon Greenaway, Karen LeGrow, Robyn Lippett, Sarah Malecki, Susan Miranda, Mahendranath Moharir, Paula Robeson, Monica Taryan, Eryn Vandepoele, Brenda Weitzner
Format: Article
Language:English
Published: BMJ Publishing Group 2024-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/14/12/e086088.full
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author Noah M Ivers
Sanjay Mahant
Sara Santos
Colin Macarthur
Kevin Thorpe
Julia Orkin
Nora Fayed
Audrey Lim
Myla E Moretti
Joanna Soscia
Eyal Cohen
Lacey Phillips
Sherry Espin
Reshma Amin
Donna Thomson
Alene Toulany
Yona Lunsky
Sanober Diaz
Megan Henze
Sherri Adams
Stacey Bernstein
Brenda Blais
Natasha Bruno
Kimberly Colapinto
Jon Greenaway
Karen LeGrow
Robyn Lippett
Sarah Malecki
Susan Miranda
Mahendranath Moharir
Paula Robeson
Monica Taryan
Eryn Vandepoele
Brenda Weitzner
author_facet Noah M Ivers
Sanjay Mahant
Sara Santos
Colin Macarthur
Kevin Thorpe
Julia Orkin
Nora Fayed
Audrey Lim
Myla E Moretti
Joanna Soscia
Eyal Cohen
Lacey Phillips
Sherry Espin
Reshma Amin
Donna Thomson
Alene Toulany
Yona Lunsky
Sanober Diaz
Megan Henze
Sherri Adams
Stacey Bernstein
Brenda Blais
Natasha Bruno
Kimberly Colapinto
Jon Greenaway
Karen LeGrow
Robyn Lippett
Sarah Malecki
Susan Miranda
Mahendranath Moharir
Paula Robeson
Monica Taryan
Eryn Vandepoele
Brenda Weitzner
author_sort Noah M Ivers
collection DOAJ
description Introduction Children with medical complexity (CMC) have chronic, intensive care needs managed by many healthcare practitioners. Medical advances have enabled CMC to survive well into adulthood. However, the availability of supports as CMC transition into the adult care system remain suboptimal, contributing to poor care coordination, and discontinuity. Promoting Intensive Transitions for Children and Youth with Medical Complexity from Paediatric to Adult Care (PITCare) aims to assess whether intensive patient and caregiver-oriented transition support beyond age 18 will improve continuity of care for CMC compared with usual care.Methods and analysis This is a pragmatic superiority randomised controlled trial in a parallel group, two-arm design with an embedded qualitative component. CMC turning 17.5 years old will be recruited (n=154), along with their primary caregiver. Participants randomised to the intervention arm will be provided with access to a multidisciplinary transition team who will support patients and caregivers in care planning, integration with an adult primary care provider (PCP), adult subspecialty facilitation and facilitation of resource supports for 2 years. Outcomes will be measured at baseline, 12 and 24 months. The primary outcome measure is successful transfer completion, defined as continuous care in the 2 years after age 18 years old. Secondary outcomes include satisfaction with transitional care, self-management, care coordination, healthcare service use, caregiver fatigue, family distress, utility and cost-effectiveness. Qualitative interviews will be conducted to explore the experiences of patients, caregivers, the transition team, and healthcare providers with the PITCare intervention.Ethics and dissemination Institutional approval was obtained from the Hospital for Sick Children Research Ethics Board. Our findings and resources will be shared with child health policymakers and transitions advocacy groups provincially, nationally, and internationally.Trial registration number ClinicalTrials.gov, US National Library of Medicine, National Institutes of Health, #NCT06093386.
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spelling doaj-art-285689e4ea1249af9f958301dfeddf842024-12-27T11:25:13ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2024-086088Promoting Intensive Transitions for Children and Youth with Medical Complexity from Paediatric to Adult Care: the PITCare study—protocol for a randomised controlled trialNoah M Ivers0Sanjay Mahant1Sara Santos2Colin Macarthur3Kevin Thorpe4Julia Orkin5Nora Fayed6Audrey Lim7Myla E Moretti8Joanna Soscia9Eyal Cohen10Lacey Phillips11Sherry Espin12Reshma Amin13Donna Thomson14Alene Toulany15Yona Lunsky16Sanober Diaz17Megan Henze18Sherri Adams19Stacey Bernstein20Brenda Blais21Natasha Bruno22Kimberly Colapinto23Jon Greenaway24Karen LeGrow25Robyn Lippett26Sarah Malecki27Susan Miranda28Mahendranath Moharir29Paula Robeson30Monica Taryan31Eryn Vandepoele32Brenda Weitzner33Department of Family Medicine, University of Toronto, Toronto, Ontario, CanadaDivision of Pediatric Medicine, Complex Care Program, The Hospital for Sick Children, Toronto, Ontario, CanadaChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, CanadaChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, CanadaUniversity of Toronto Dalla Lana School of Public Health, Toronto, Ontario, CanadaChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, CanadaSchool of Rehabilitation Therapy, Queen`s University, Kingston, Ontario, CanadaDepartment of Pediatrics, Hamilton Health Sciences Center, McMaster University, Hamilton, New York, CanadaChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, CanadaDivision of Pediatric Medicine, Complex Care Program, The Hospital for Sick Children, Toronto, Ontario, CanadaChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, CanadaOntario Health, Toronto, Ontario, CanadaToronto Metropolitan University, Toronto, Ontario, CanadaChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, CanadaChild Health Evaluative Sciences, PITCare Patient and Caregiver Advisory Committee, The Hospital for Sick Children, Toronto, Ontario, CanadaChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, CanadaCentre for Addiction and Mental Health, Toronto, Ontario, CanadaProvincial Council for Maternal and Child Health, Toronto, Ontario, CanadaSurrey Place Centre, Toronto, Ontario, CanadaDivision of Pediatric Medicine, Complex Care Program, The Hospital for Sick Children, Toronto, Ontario, CanadaDivision of Pediatric Medicine, Complex Care Program, The Hospital for Sick Children, Toronto, Ontario, CanadaChild Health Evaluative Sciences, PITCare Patient and Caregiver Advisory Committee, The Hospital for Sick Children, Toronto, Ontario, CanadaChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, CanadaDivision of Pediatric Medicine, Complex Care Program, The Hospital for Sick Children, Toronto, Ontario, CanadaErinoakKids Centre for Treatment and Development, Mississauga, Ontario, CanadaToronto Metropolitan University, Toronto, Ontario, CanadaDivision of Pediatric Medicine, Complex Care Program, The Hospital for Sick Children, Toronto, Ontario, CanadaChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, CanadaDivision of Pediatric Medicine, Complex Care Program, The Hospital for Sick Children, Toronto, Ontario, CanadaDepartment of Paediatrics, Division of Neurology, The Hospital for Sick Children, Toronto, Ontario, CanadaChildren`s Healthcare Canada, Ottawa, Ontario, CanadaChild Health Evaluative Sciences, PITCare Patient and Caregiver Advisory Committee, The Hospital for Sick Children, Toronto, Ontario, CanadaDepartment of Pediatrics, Division of Adolescent Medicine, The Hospital for Sick Children, Toronto, Ontario, CanadaDepartment of Family Medicine, University of Toronto, Toronto, Ontario, CanadaIntroduction Children with medical complexity (CMC) have chronic, intensive care needs managed by many healthcare practitioners. Medical advances have enabled CMC to survive well into adulthood. However, the availability of supports as CMC transition into the adult care system remain suboptimal, contributing to poor care coordination, and discontinuity. Promoting Intensive Transitions for Children and Youth with Medical Complexity from Paediatric to Adult Care (PITCare) aims to assess whether intensive patient and caregiver-oriented transition support beyond age 18 will improve continuity of care for CMC compared with usual care.Methods and analysis This is a pragmatic superiority randomised controlled trial in a parallel group, two-arm design with an embedded qualitative component. CMC turning 17.5 years old will be recruited (n=154), along with their primary caregiver. Participants randomised to the intervention arm will be provided with access to a multidisciplinary transition team who will support patients and caregivers in care planning, integration with an adult primary care provider (PCP), adult subspecialty facilitation and facilitation of resource supports for 2 years. Outcomes will be measured at baseline, 12 and 24 months. The primary outcome measure is successful transfer completion, defined as continuous care in the 2 years after age 18 years old. Secondary outcomes include satisfaction with transitional care, self-management, care coordination, healthcare service use, caregiver fatigue, family distress, utility and cost-effectiveness. Qualitative interviews will be conducted to explore the experiences of patients, caregivers, the transition team, and healthcare providers with the PITCare intervention.Ethics and dissemination Institutional approval was obtained from the Hospital for Sick Children Research Ethics Board. Our findings and resources will be shared with child health policymakers and transitions advocacy groups provincially, nationally, and internationally.Trial registration number ClinicalTrials.gov, US National Library of Medicine, National Institutes of Health, #NCT06093386.https://bmjopen.bmj.com/content/14/12/e086088.full
spellingShingle Noah M Ivers
Sanjay Mahant
Sara Santos
Colin Macarthur
Kevin Thorpe
Julia Orkin
Nora Fayed
Audrey Lim
Myla E Moretti
Joanna Soscia
Eyal Cohen
Lacey Phillips
Sherry Espin
Reshma Amin
Donna Thomson
Alene Toulany
Yona Lunsky
Sanober Diaz
Megan Henze
Sherri Adams
Stacey Bernstein
Brenda Blais
Natasha Bruno
Kimberly Colapinto
Jon Greenaway
Karen LeGrow
Robyn Lippett
Sarah Malecki
Susan Miranda
Mahendranath Moharir
Paula Robeson
Monica Taryan
Eryn Vandepoele
Brenda Weitzner
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
title Promoting Intensive Transitions for Children and Youth with Medical Complexity from Paediatric to Adult Care: the PITCare study—protocol for a randomised controlled trial
title_full Promoting Intensive Transitions for Children and Youth with Medical Complexity from Paediatric to Adult Care: the PITCare study—protocol for a randomised controlled trial
title_fullStr Promoting Intensive Transitions for Children and Youth with Medical Complexity from Paediatric to Adult Care: the PITCare study—protocol for a randomised controlled trial
title_full_unstemmed Promoting Intensive Transitions for Children and Youth with Medical Complexity from Paediatric to Adult Care: the PITCare study—protocol for a randomised controlled trial
title_short Promoting Intensive Transitions for Children and Youth with Medical Complexity from Paediatric to Adult Care: the PITCare study—protocol for a randomised controlled trial
title_sort promoting intensive transitions for children and youth with medical complexity from paediatric to adult care the pitcare study protocol for a randomised controlled trial
url https://bmjopen.bmj.com/content/14/12/e086088.full
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