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

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

A feasibility Randomised Controlled Trial as a first step towards evaluating the effectiveness of a digital health dashboard in preventive child health care: a mixed methods approach

“…This research with an explanatory-sequential mixed methods design included a quantitative and subsequential qualitative part [ 11 , 14 , 15 ]. Within a small-scale RCT, quantitative measurements were performed.…”

“…Within a small-scale RCT, quantitative measurements were performed. Then, qualitative methods (semi-structured interviews and focus groups) were used to gain a deeper understanding of the quantitative findings regarding the feasibility of performing an RCT [ 11 , 14 , 15 ]. Our reporting follows the CONSORT guidelines (see CONSORT checklist in supplemental files) [ 16 ].…”

“…Quantitative data were used to direct the sampling strategy of the qualitative part and for refining topic lists. Furthermore, during qualitative analysis, the quantitative findings were considered and intensively compared in the discussion of overarching themes/categories [ 11 ].…”

“…As such a schedule would require multiplying the sample size of participants, this option was not possible within this feasibility study. Randomisation was performed at the level of individual parents by an independent person, who used a central block randomisation application to assign recruited parents to one of the two study arms (with blocks of 4 and 6) [ 11 ].…”

“…To initiate the evaluation of the prerequisites of studying 360°CHILD-profile’s effectiveness within real-life healthcare practice, a feasibility RCT was executed [ 9 ]. This study, which evaluated methodological aspects of setting up an RCT, was part of a larger mixed methods research project that also studied the implementation and usability of the 360°CHILD-profile, which is published elsewhere [ 11 ].…”