Introduction

The Neonatal Intensive Care Unit (NICU) is a stressful environment for parents and being invited to participate in clinical research may add to the strain. Providing information helps reduce parental stress, promotes involvement in care for their infant, and establishes Family Integrated Care.^1–2 Explanation of procedures, complex information and terminologies using infographics can help parental understanding of risk/benefits for research and treatment.³ Neonatal seizures are typically sudden and unexpected events, therefore, recent recommendations reiterate that parents need clear explanation of trial procedures.⁴ EEG vs aEEG to improve the diagnosis of neonatal seizures and epilepsy- a randomised controlled trial (EAGLET) is a multi-centre study in the UK to compare monitoring of aEEG vs full EEG with integrated aEEG with intermittent neurophysiology reporting. The original (traditional) EAGLET parent information leaflet (PIL) was redesigned with the following design procedures: commissioning professional designer’s service; incorporation of parental feedback and infographics to simplify complex terminologies; and diagrammatic explanation of workflow.

Clinical Trials

gov ID: NCT05079971; Integrated Research Application System ID: 302295

Objective

To evaluate parental feedback regarding acceptability and effectiveness of two versions of EAGLET parent information leaflets (PIL) by comparing PIL-T (traditional) vs PIL-IG (infographic).

Methods

Service evaluation project at sponsor site Online anonymised questionnaire (9 questions) via QR code 5-point Likert scale (fully agree/agree/neither agree or disagree/disagree/fully disagree) used Inclusion criteria: Parents whose infants were monitored on NICU, stepped-down to low dependancy/transitional care. Exclusion criteria: Infants not monitored on NICU; parents unavailable.

Results

During the survey period (December 2022-January 2023), 49 parents were approached from whom 18 responses were obtained. PIL-IG received 100% parental agreement for 2/8 categories i.e., ease of reading and understanding study procedures. Further, for 4/8 categories: comprehensiveness; finding contact information; understanding terminologies and workflow; and finding answers, 94% respondents fully agreed/agreed with PIL-IG than PIL-T. In the remaining two categories, PIL-T performed unfavourably. More than 50% parents reported that based on PIL-T, they would not recommend/refer the trial. Similarly, >25% respondents disagreed about confidence to participate in the trial by reading PIL-T alone. Reassuringly, 100% and >94% respondents in both those categories respectively agreed with PIL-IG. Summary and comparison of responses shown in table.1. Additionally, free text comments demonstrated positive feedback favouring PIL-IG.

Conclusions

Communication is key in NICU especially in context of recruitment to time-sensitive trials. Infographics in PIL could impact parent engagement, confidence, and possible success of clinical trials.

References

Bracht M, et al. Implementing family-integrated care in the NICU: a parent education and support program. Adv Neonatal Care. Apr 2013;13(2):115–26. Bliss for babies born premature or sick. https://www.bliss.org.uk/health-professionals/information-and-resources/resources-for-parents Tait AR, et al. Presenting research risks and benefits to parents: does format matter? Anesth Analg. 2010 Sep;111(3):718–23. Soul JS, et al. Recommendations for the design of therapeutic trials for neonatal seizures. Pediatr Res. 2019 Jun;85(7):943–954.