Parent co-Designed Drug Information for parents and Guardians Taking Neonates home (PADDINGToN) a mixed method approach to defining and evaluating information resources

Background A study of premature babies, less than 32 weeks gestation, found that the median number of medicines per patient at discharge was 2.5 (range 2 to 7), with 28% of babies discharged on more than 3 medicines ([1][1]). Medication administration to infants can cause anxiety and concern for parents/carers who worry about making mistakes. A systematic review of carers for all ages has estimated the administration error rate at home to be between 2 and 33% ([2][2]) while a rate of 66.3% was recorded in medication administered to premature infants where parents were responsible for administration ([3][3]). It has also been reported that up to 90% of carers will administer a medicine incorrectly at some point ([2][2]). The aim of this study is to work with healthcare professionals (HCPs) and parents/carers to co-design resources aimed at improving medication safety and reducing parental anxiety for those giving medications to neonates at home. Methods Work Package 1: Project management and co-ordination phase : preparation of protocols and survey material and ethics approval applications. Work Package 2: Stakeholder engagement phase, e-surveys and focus groups: An electronic-survey (e-survey) will be developed by a multi-disciplinary study management group (SMG). This will be circulated to HCPs involved in the care of neonates and parents/carers whose babies had recently been discharged from hospital. A small number of parents/carers will be invited to take part in focus groups. Work Package 3: Co-design of resources and quantitative evaluation : Parents/carers willing to co-design educational and information resources to support safe administration of medicines to neonates following discharge will be recruited. A quantitative evaluation of the effect of the resource will be conducted with a new group of caregivers to measure specific outcome(s). Discussion This study aims to co-develop, with healthcare professionals (HCPs) and parents/carers, resources aimed at improving medication safety and reducing parental anxiety for those giving medications to neonates at home. Co-development of resources with HCPs and parents, ensures that the project outcomes are relevant and useful, leading to a reduction in parental anxiety. Trial registration ISRCTN registry Ref 17332620 ### Competing Interest Statement Andrea Gill and Neil Caldwell both have non-financial competing interests as committee members of the funding body NPPG. However, they were excluded from the grant application and review process, which was peer reviewed. The rest of the authors have declared that no competing interests exist. ### Funding Statement This study is funded by the Neonatal and Paediatric Pharmacists Group UK. LB, AG and FOB were the recipients of the grant. The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethical approval has been sought and granted from an approved NHS ethics committee NRES London - Bloomsbury Research Ethics Committee and HRA and Health and Care Research Wales (HCRW) (reference: 21/LO/0351). Ethical approval was sought and granted from the ethics committee at the Rotunda Hospital, Dublin, Ireland : REC-2021-O13 I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Not Applicable I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Not Applicable I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Not Applicable No datasets were generated or analysed during the current study. All relevant deidentified data from this study will be made available upon study completion. * AH : Alder Hey ANNP : advanced neonatal nurse practitioner FA : Framework Analysis FICare : family integrated care Healthcare professionals (HCPs) HSE : Health Service Executive MfC : Medicines for Children MODRIC : Modification of Drugs Required in Children NHS : National Health Service NPPG : Neonatal and Paediatric Pharmacists Group PMRU : Paediatric Medicines Research Unit RCSI : Royal College of Surgeons in Ireland SMG : study management group WP : work packages [1]: #ref-1 [2]: #ref-2 [3]: #ref-3