Parent co-Designed Drug Information for parents and Guardians Taking Neonates home (PADDINGToN 2) – a Feasibility Study
Whether giving information resources about medicines helps parents/carers take their baby home from a neonatal unit
Current interventions as of 25/04/2025: The study will involve 3 work packages: Work Package A- The preparatory phase will start with establishing the resources on an electronic platform (vCreate), allowing translation into 12 languages. The study management group and literature review will inform the implementation method for neonatal units (NNUs). Semi-structured interviews with PADDINGToN Parent Advisory Group (PPAG) members and other targeted groups will explore views on recruitment, retention, data collection and tools. Analysis of transcribed interviews will use reflexive thematic analysis. Work Package B - The feasibility phase will establish recruitment (target n=75) and retention (target n=52) rates. Reasons for attrition will be determined, and fidelity of the intervention will be tested over time and in NNUs of varying clinical designation using direct observation and feedback from parents. Parental anxiety and confidence will be assessed using a variety of tools. There are 3 optional study arms. Healthcare utilisation patterns and any association between parental confidence and medication errors will be explored in a subgroup of participants (10-15). Work Package C: The Reflection phase will involve qualitative exploration of participant perspectives, both HCPs (10-15)and parents (10-15) on feasibility and utility of the intervention. The parent interviews will be conducted within a month of the parent completing the feasibility study. Acceptability will be assessed using Sekhon’s Theoretical Framework of Acceptability. Development of an application for an RCT will also be undertaken during this phase Parents will be asked to consent to their preferred method of contact: email, telephone, or receive SMSs via a third-party messaging service as part of the PADDINGToN-2 study. They will be asked to state their preferred method(s) on the consent form. Previous interventions: This project will be divided into three work packages: Work package 1
1. PPAG - Parents/Carers whose baby has recently (ideally within 2 years but up to 5 years) been discharged from the neonatal unit and whose medication has been continued after discharge 2. WPB - Parents/Carers of babies receiving care on a neonatal unit who will require medication to be continued after discharge home from the hospital 3. WPC- Parents/Carers (10-15) and HCPs (10-15) who completed Work Package- B (WP-B) Feasibility 4. All WPs - Parents/Carers who do not speak any English will be eligible to take part in the interviews. Translation services will be provided to facilitate this 5. Community Parent Champions and community health care professionals 6. HCPS providing neonatal care in any of the four study sites or stakeholder groups from PADDINGToN1
1. Parents/Carers whose baby’s medication is likely to stop before discharge 2. Parents/Carers whose baby has a terminal diagnosis of a severe congenital abnormality or critical illness (unlikely to survive) 3. Parents/Carers unwilling to have audio-visual recordings of focus groups/interviews 4. HCPs not providing care to neonates requiring medicines