促进患有复杂疾病的儿童和青少年从儿科护理向成人护理的强化过渡：PITCare研究——一项随机对照试验的方案

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

作者信息

Santos Sara, Thomson Donna, Diaz Sanober, Soscia Joanna, Adams Sherri, Amin Reshma, Bernstein Stacey, Blais Brenda, Bruno Natasha, Colapinto Kimberly, Espin Sherry, Fayed Nora, Greenaway Jon, Henze Megan, Ivers Noah M, LeGrow Karen, Lim Audrey, Lippett Robyn, Lunsky Yona, Macarthur Colin, Mahant Sanjay, Malecki Sarah, Miranda Susan, Moharir Mahendranath, Moretti Myla E, Phillips Lacey, Robeson Paula, Taryan Monica, Thorpe Kevin, Toulany Alene, Vandepoele Eryn, Weitzner Brenda, Orkin Julia, Cohen Eyal

机构信息

Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.

Child Health Evaluative Sciences, PITCare Patient and Caregiver Advisory Committee, The Hospital for Sick Children, Toronto, Ontario, Canada.

出版信息

BMJ Open. 2024 Dec 9;14(12):e086088. doi: 10.1136/bmjopen-2024-086088.

DOI:10.1136/bmjopen-2024-086088

PMID:39653557

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11628984/

Abstract

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.

摘要

引言

患有复杂疾病的儿童（CMC）有长期的重症护理需求，需要多名医疗从业者进行管理。医学进步使CMC能够顺利活到成年。然而，当CMC过渡到成人护理系统时，支持措施的可用性仍然不理想，导致护理协调不善和连续性中断。促进患有复杂疾病的儿童和青少年从儿科到成人护理的强化过渡（PITCare）旨在评估，与常规护理相比，18岁以后以患者和照顾者为导向的强化过渡支持是否会改善CMC的护理连续性。

方法与分析

这是一项实用的优效性随机对照试验，采用平行组双臂设计，并嵌入定性研究部分。将招募年满17.5岁的CMC及其主要照顾者（n = 154）。随机分配到干预组的参与者将能够获得一个多学科过渡团队的支持，该团队将在护理计划、与成人初级保健提供者（PCP）整合、成人专科医疗协调以及资源支持协调方面为患者和照顾者提供2年的支持。将在基线、12个月和24个月时测量结果。主要结局指标是成功完成转诊，定义为18岁后两年内的连续护理。次要结局包括对过渡护理的满意度、自我管理、护理协调、医疗服务使用、照顾者疲劳、家庭困扰、效用和成本效益。将进行定性访谈，以探索患者、照顾者、过渡团队和医疗提供者对PITCare干预的体验。