A feasibility Randomised Controlled Trial as a first step towards evaluating the effectiveness of a digital health...

Within preventive Child Health Care (CHC), the 360°CHILD-profile has been developed. This digital tool visualises and theoretically orders holistic health data in line with the International Classification of Functioning, Disability and Health. It is anticipated that evaluating the effectiveness of the multifunctional 360°CHILD-profile within the preventive CHC-context is complex. Therefore, this study aimed at investigating the feasibility of RCT procedures and the applicability of potential outcome measures for assessing the accessibility and transfer of health information.

During the first introduction of the 360°CHILD-profile in CHC practice, a feasibility RCT with an explanatory-sequential mixed methods design was executed. CHC professionals (n=38) recruited parents (n=30) who visited the CHC for their child (age 0-16). Parents were randomised to "care as usual" (n=15) or "care as usual with, in addition, the availability of a personalised 360°CHILD-profile during 6 months" (n=15). Quantitative data on RCT feasibility were collected on recruitment, retention, response, compliance rates and outcome data on accessibility and transfer of health information (n=26). Subsequently, thirteen semi-structured interviews (5 parents, 8 CHC professionals) and a member check focus group (6 CHC professionals) were performed to further explore and gain a deeper understanding of quantitative findings.

Integration of qualitative and quantitative data revealed that the recruitment of parents by CHC professionals was problematic and influenced by organisational factors. The used randomisation strategy, interventions and measurements were executable within the setting of this specific study. The outcome measures showed skewed outcome data in both groups and a low applicability to measure accessibility and transfer of health information. The study revealed points to reconsider regarding the randomisation and recruitment strategy and measures in the next steps.

This mixed methods feasibility study enabled us to gain a broad insight into the feasibility of executing an RCT within the CHC context. Trained research staff should recruit parents instead of CHC professionals. Measures, potentially for evaluating 360°CHILD-profile's effectiveness, need further exploration and thorough piloting before proceeding with the evaluation process. Overall findings revealed that executing an RCT within the context of evaluating 360°CHILD-profile's effectiveness in the CHC setting will be much more complex, time-consuming and costly than expected. Thereby, the CHC context requires a more complex randomisation strategy than executed during this feasibility study. Alternative designs including mixed methods research must be considered for the next phases of the downstream validation process.

NTR6909; https://trialsearch.who.int/ .