一项针对儿童预防性保健中新型个性化健康仪表盘的评估：混合方法可行性随机对照试验方案。

Evaluation of a New Personalized Health Dashboard in Preventive Child Health Care: Protocol for a Mixed Methods Feasibility Randomized Controlled Trial.

作者信息

Weijers Miriam, Feron Frans, van der Zwet Jonne, Bastiaenen Caroline

机构信息

Department of Preventive Child Health Care, Municipal Health Services, South Limburg, Heerlen, Netherlands.

Department of Social Medicine, Faculty of Health, Medicine and Life Sciences, Care and Public Health Research Institute, Maastricht University, Maastricht, Netherlands.

出版信息

JMIR Res Protoc. 2021 Mar 16;10(3):e21942. doi: 10.2196/21942.

DOI:10.2196/21942

PMID:33724191

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8088845/

Abstract

BACKGROUND

A new dashboard, the 360ºCHILD-profile, was developed to adopt personalized health care within preventive child health care. On this profile, holistic health data are visualized in a single image to provide parents, adolescents, and caregivers direct access to a manageable résumé of a child's medical record. Theoretical ordering, conforming to "International Classification of Functioning, Disability and Health for Children and Youth", guides clinical reasoning toward the biopsychosocial concept of health. It is yet unknown if and how this promising tool functions in practice, and a variety of feasibility questions must be addressed.

OBJECTIVE

This paper describes the design and methods of a feasibility randomized controlled trial (RCT), with the aim of evaluating the RCT's feasibility (recruitment, response, measure completion, and intervention allocation) and 360ºCHILD-profile's feasibility (usability and potential effectiveness).

METHODS

A pragmatic mixed methods study design was chosen, starting with an RCT to measure feasibility and health literacy in 2 parallel groups (1:1). Qualitative research will then be used to understand and explain quantitative findings and to explore the stakeholders' perspectives on the potential of the 360ºCHILD-profile. Participants will include child health care professionals (n≥30), parents (n≥30), and caregivers (n≥10) of children who experience developmental problems (age 0-16 years). Children will only be able to participate if they are older than 11 years (adolescents, n≥10). The 2 groups included in the study will receive standard care. The experimental group will additionally receive personalized 360ºCHILD-profiles.

RESULTS

After an intervention period of 6 months, quantitative outcomes will be measured, analyzed (descriptive feasibility statistics and preliminary between-group differences) and used to purposively sample for semistructured interviews.

CONCLUSIONS

Study results will provide knowledge for building theory on the 360ºCHILD-profile and designing future (effect) studies.

TRIAL REGISTRATION

Netherlands Trial Register NTR6909; https://www.trialregister.nl/trial/6731.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21942.

摘要

背景

开发了一种新的仪表盘——360º儿童健康档案，以在儿童预防性保健中采用个性化医疗保健。在此档案中，整体健康数据在一张图片中可视化，为父母、青少年和护理人员提供直接访问儿童病历可管理摘要的途径。符合“儿童和青少年功能、残疾与健康国际分类”的理论排序指导临床推理朝着健康的生物心理社会概念发展。该有前景的工具在实践中是否以及如何发挥作用尚不清楚，必须解决各种可行性问题。

目的

本文描述了一项可行性随机对照试验（RCT）的设计和方法，旨在评估RCT的可行性（招募、反应、测量完成情况和干预分配）以及360º儿童健康档案的可行性（可用性和潜在有效性）。

方法

选择了一种务实的混合方法研究设计，首先进行RCT，以测量两个平行组（1:1）中的可行性和健康素养。然后将使用定性研究来理解和解释定量结果，并探索利益相关者对360º儿童健康档案潜力的看法。参与者将包括儿童保健专业人员（n≥30）、父母（n≥30）以及有发育问题儿童（0 - 16岁）的护理人员（n≥10）。只有年龄超过11岁的儿童（青少年，n≥10）才能参与。研究中的两个组将接受标准护理。实验组还将额外获得个性化的360º儿童健康档案。