Nageswaran Savithri, Easterling Douglas, Ingram Cobi W, Skaar Jamie E, Miller-Fitzwater Anna, Ip Edward H
Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC, USA.
Department of Social Sciences & Health Policy, Wake Forest School of Medicine, Winston-Salem, NC, USA.
Contemp Clin Trials Commun. 2020 Dec;20:100652. doi: 10.1016/j.conctc.2020.100652. Epub 2020 Sep 18.
This article describes the study protocol for an evaluation of an innovative model of care that supports home health nurses (HHN) who serve children with medical complexity (CMC). CMC constitute a small proportion of children, but have very high need for health services, are hospitalized frequently, and account for significant proportion of pediatric healthcare expenditures. High-quality home health nursing services are important for CMC, but models of care of home healthcare, after discharge of CMC from the hospital, have not been tested. Our project aims are to develop, implement, and test a model of care, called ICollab, to improve home healthcare delivery for CMC. The ICollab model consists of collaboration between HHN, primary-care physicians and clinicians of the complex care program of a tertiary-care children's hospital in the care of CMC. In this randomized clinical trial, we will recruit 110 CMC discharged home on home health nursing services. The intervention group (n = 55) will receive the ICollab intervention for 6 months post-discharge from the hospital, in addition to usual care. Children in the control group (n = 55) will receive only usual care. Outcome measures will include healthcare utilization metrics (hospitalization rates, emergency room visit rates, and days to readmission), caregiver burden and caregiver satisfaction with home healthcare, HHN retention, and HHN collaboration with other healthcare providers. We hypothesize that ICollab will reduce healthcare utilization and caregiver burden, and improve caregiver satisfaction with home healthcare, increase HHN retention, and increase HHN collaboration with other healthcare providers. Results of this study have the potential to provide a critically needed evidence-base for interventions to improve the quality of healthcare delivery for CMC. This study is registered on clinicaltrials.gov (NCT03978468) and is ongoing.
本文介绍了一项研究方案，该方案旨在评估一种创新的护理模式，该模式为照顾患有复杂疾病的儿童（CMC）的家庭健康护士（HHN）提供支持。患有复杂疾病的儿童在儿童中占比小，但对医疗服务的需求非常高，经常住院，且占儿科医疗支出的很大比例。高质量的家庭健康护理服务对患有复杂疾病的儿童很重要，但在这些儿童出院后，家庭医疗护理模式尚未经过测试。我们的项目目标是开发、实施并测试一种名为ICollab的护理模式，以改善为患有复杂疾病的儿童提供的家庭医疗服务。ICollab模式包括家庭健康护士、初级保健医生以及一家三级儿童医院复杂护理项目的临床医生之间就照顾患有复杂疾病的儿童展开合作。在这项随机临床试验中，我们将招募110名接受家庭健康护理服务后出院回家的患有复杂疾病的儿童。干预组（n = 55）除接受常规护理外，还将在出院后6个月接受ICollab干预。对照组（n = 55）的儿童将仅接受常规护理。结果指标将包括医疗服务利用指标（住院率、急诊室就诊率和再次入院天数）、照顾者负担以及照顾者对家庭医疗服务的满意度、家庭健康护士的留用率，以及家庭健康护士与其他医疗服务提供者的合作情况。我们假设ICollab将降低医疗服务利用率和照顾者负担，提高照顾者对家庭医疗服务的满意度，增加家庭健康护士的留用率，并增加家庭健康护士与其他医疗服务提供者的合作。这项研究的结果有可能为改善为患有复杂疾病的儿童提供医疗服务质量的干预措施提供急需的证据基础。本研究已在clinicaltrials.gov上注册（NCT0397846），目前正在进行中。
