To more effectively address the increasing burden of preventable chronic diseases, it is a prerequisite for current reactive health care (treatment after a diagnosis) to make the transition to personalized health care (PHC) [1]. According to Snyderman [2], PHC stands for a lifetime, holistic approach of proactively offering predictive, preventive, personalized, and participatory care. The different PHC concepts can and must be introduced in practice as soon as possible, but it appears to be a challenging task to effectuate such a new approach within health care [2,3].

Dutch preventive child health care (CHC), as part of public health, offers a unique platform to adopt PHC in the short term. CHC proactively monitors children’s development and health to detect early deviance from normal variance and diseases or symptoms which cannot yet be clustered to a diagnosis. To fully apply PHC within the preventive CHC approach, a shift is needed toward prediction and prevention in the very early stages of disease progression when symptoms may not even be present [4,5]. To perform early detection and act upon disease progression is not an easy task because health processes are complex. The biopsychosocial model of health shows that health is a result of lifelong, multidimensional interactions between many biological–genetic characteristics and environmental factors. Therefore, to predict and protect health, insight into a broad set of health determinants is required. Critical to implementation of PHC is thus the availability and accessibility of high-quality, relevant lifetime health data.

From birth on, CHC collects health data about the child and environment, which are stored in an electronic medical dossier (EMD). However, accessibility of data is profoundly hindered due to the actual structure of EMDs, and thus support for the complex clinical reasoning process is insufficient [6,7]. It is not possible to generate an adequate overview of registered data in coherence with the relevant theoretical concepts (ie, the biopsychosocial model) [8]. As a result, much of the CHC-data that are highly relevant to understanding the complex processes underlying health are not available within the timeframe of CHC visits or other consultations with caregivers and parents.

To address this problem, a 360ºCHILD-profile (Figure 1), which visualizes health information about the child and environment in a single digital image, has been originally developed and examined within daily practice of the Dutch CHC system [9].

Relevant CHC data, visualized on the 360ºCHILD-profile, are theoretically ordered according to the “International Classification of Functioning, Disability and Health for Children and Youth” (ICF-CY) [10]. The ICF-CY fits the CHC context and PHC concepts, as it is built on the integrated biopsychosocial approach of health and describes a broad variety of individual characteristics and environmental factors in concrete, neutral (if not positive) formulations [10]. The 360ºCHILD-profile was developed as a dashboard that provides a quick, systemic, and comprehensible representation of a child’s individually unique set of health determinants (protective and risk factors).

The goal of the 360ºCHILD-profile is to provide direct access to a manageable résumé of holistic health information stored in the EMD to CHC professionals, parents, and adolescents, and to naturally guide thought processes in coherence with the chosen theoretical perspective (PHC). This dashboard supports health literacy in a way that can empower parents and adolescents to cocreate personalized plans for managing their (children’s) health, in partnership with caregivers [11,12].

From the very start of the 360ºCHILD-profile’s development and research project (2012), parents, adolescents, and CHC professionals have been actively involved. Formal ideas for designing the profile’s first drafts were generated, and pilot studies showed positive reactions of stakeholders for the comprehensibility, relevance, and acceptability of the design [9]. Promising results were generated in another study related to the 360ºCHILD-profile’s reliability and validity when used by CHC medical doctors to assess child functioning [13]. In 2018, data visualization designers and researchers used their expertise and gained input from stakeholders on CHC context, usability, and user experience to redesign the 360ºCHILD-profile [9].

The current state of this newly developed 360ºCHILD-profile offers a promising, online dashboard that is ready to be introduced into CHC practice. If and how it will actually function within daily practice is yet unknown, and it is foreseen that the evaluation of effectiveness in the multidisciplinary and preventive CHC context will be complex. Therefore, a pragmatic feasibility RCT will be performed to refine our practice-derived theory on the 360ºCHILD-profile’s feasibility and potential effectiveness and to build a rationale for designing future (effect) studies (including outcome measures and sample size calculations) [14,15]. The aim of this paper is to describe the design and methods of this study that will be performed within CHC.

The intended timeline for achieving the targeted results includes the acceptance for funding (December 2016), approval by The Medical Ethics Committee of the Maastricht University Medical Centre (no. METC azM/UM 2017-0089; July 2017), registration in the Netherlands National Register (6909; January 2018), enrolment of participants (May 2018 to September 2019), quantitative outcome data collection (March 2019 to September 2020), and qualitative data collection (October 2019 to February 2021). The results of the presented study will be available before the end of 2021. 

This pragmatic quantitative–qualitative study will comprehensively evaluate the feasibility of the newly developed 360ºCHILD-profile and the feasibility of conducting an RCT within the preventive setting of the CHC.

This practice-derived dashboard is new in providing a holistic and structured display (in accordance with the ICF-CY framework) of the large and complex electronic CHC data sets [13]. Earlier pilot studies, application tests, and qualitative user tests have already shown promising results for the relevance, comprehensibility, acceptability, reliability, and validity of the 360ºCHILD profile [9,13]. However, these pilots and validation tests were all performed during sessions guided by researchers in order to optimize technical and visual aspects and to increase the likelihood of usability and effectiveness. Thus, this feasibility study will generate first results on usability of this promising tool within the real-life CHC practice. This study will also generate indispensable knowledge on how to test the efficacy of this practice-derived innovation in the CHC context and is a necessary and sound intermediate step in the overall multiyear mixed methods research project [15,16].

From a pragmatic viewpoint, we searched for design options that fit current research questions and CHC context. A mixed methods design with a sequential explanatory (quantitative–qualitative) setup was chosen to enable testing our a priori, practice-based hypotheses and to give voice to parents, adolescents, and caregivers to refine theory. The pragmatic approach of the feasibility RCT enables the execution of a randomized trial within the preventive and multidisciplinary field of work and generation of results that fit this context [17]. The investment of time by CHC professionals is limited as much as possible; only a short training period is needed, each professional will need to recruit only 1-2 parent(s), and professionals are left close to daily practice during the “intervention” period (care as usual). Furthermore, CHC professionals in the experimental group do not have to drastically change their working method; they will present the personalized profile to parents and adolescents, but after that, all participants are free in choosing how (often) to use it. The between-group difference might seem rather subtle, but we expect it will have substantial impact. Our hypothesis is that the availability of the dashboard will automatically lead to efficiency (there is less wasting of time to search for data in the EMD and better quality of health literacy and early prevention of disease progression). Moreover, we expect that the theoretical structure of the profile will intuitively guide clinical reasoning in line with the context of CHC and PHC.

Information bias will be reduced by the centralized randomization, blinding of researchers for randomization, and keeping participants unaware of the detailed study aims.

Children and their parents have been chosen as the level of randomization (and not CHC professionals) to avoid bias due to differences in professionals’ working methods, characteristics, and level of experience. Contamination is avoided by virtue of the fact that, for CHC professionals in the control group, it is not possible to obtain an overview of the holistic health data from the EMD, as it is simply not available.

From the original study population, a heterogeneous population of participants will be selected for semistructured interviews to provide an in-depth insight into a broad spectrum of perspectives [33]. Interpretation of quantitative and qualitative data will be in coherence with each other, which strengthens the study’s internal validity and deepens our understanding of the findings.

This pragmatic study will ensure adequate evaluation of the currently relevant feasibility questions, and the findings will direct our decisions concerning the 360ºCHILD-profile’s implementation in Dutch CHC practice and the design of future (effect) studies. The eventual goal of this research project is to bridge the gap between the technical design of EMDs and clinical practice to enable EMDs to efficiently support CHC in its preventive tasks and give parents access to the EMD summaries. Therefore, CHC and parents can monitor health, detect deviation of normal variance and disease progression as early as possible, and cocreate preventive strategies to protect and promote children’s health—health plans that will fit each individually unique child.