How to adopt a Personalized approach in preventive Child Health Care? Design of a Mixed Methods Feasibility RCT. (Preprint)
BACKGROUND To adopt Personalized Health Care within preventive Child Health Care, a 360⁰CHILD-profile is developed. On this dashboard, holistic health data are visualized in one image to provide parents/youth and caregivers direct access to a manageable résumé of child’s medical record. Theoretical ordering, conform “International Classification of Functioning, Disability and Health (Children and Youth version)”, guides thought processes within the relevant context. 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 design and methods of a Feasibility RCT, to be performed in the Netherlands (January 2019 - September 2020). RCT’s feasibility (recruitment, response, measure completion, intervention allocation) and 360⁰CHILD-profile’s feasibility (usability, potential effectiveness) will be evaluated. METHODS A pragmatic Mixed Methods design is chosen, starting with an RCT to measure feasibility and health literacy in two parallel groups (1:1). Then, qualitative research will be performed to understand/explain quantitative findings and explore stakeholder’s perspectives on 360⁰CHILD-profile’s potential. Participating CHC-professionals (n≥30) will recruit parents (n≥30) and caregivers (n=±10) of children, who experience problems (age 0-16). Children will only participate if age is above 11 (youth, n=±10). Both groups receive care as usual. Experimental group, additionally, gets access to personalized 360⁰CHILD-profiles. RESULTS Six months after baseline, quantitative outcomes will be measured, analysed (descriptive feasibility statistics and preliminary between group difference) and used to purposively sample for semi-structured interviews. CONCLUSIONS Study results will provide knowledge for building theory on the CHILD-profile and designing future (effect) studies. CLINICALTRIAL Trial registration: NTR 6909; https://www.trialregister.nl/trial/6731