PADDINGToN - a study working with healthcare professionals and parents/carers to co-design resources for use in the UK and Ireland, aimed at improving medication safety for those giving medications to neonates in the home environment.
| ISRCTN | ISRCTN17332620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17332620 |
| IRAS number | 294675 |
| Secondary identifying numbers | CPMS 49192, IRAS 294675 |
- Submission date
- 28/05/2021
- Registration date
- 10/06/2021
- Last edited
- 09/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Over 100,000 babies are cared for in neonatal units in the UK and Ireland annually, either because they have been born prematurely, or born full term but require supportive care: this figure represents 1 in 7 babies born in the UK and Ireland each year. Premature neonates are often prescribed medications which require small volumes to be administered. Current practice on most neonatal units in the UK and Ireland is for nursing staff to give medicines. There have been recent moves towards parents/carers giving medicines in hospital to prepare them to give medicines to their baby at home. However, in many hospitals they are trained how to measure doses and administer medications only immediately prior to discharge. This can cause high levels of anxiety and concern for parents/carers as they worry about making a mistake measuring doses.
The aim of this project is to work with parents/carers to co-design resources aimed at improving medication safety for those giving medications to neonates in the home environment.
Who can participate?
Staff on neonatal units including: nurses, ANNPs, doctors, pharmacists and pharmacy technicians and parents/carers groups both in the UK and Ireland .
What does the study involve?
Participants will be sent an electronic survey to identify resources currently available for parents/carers.
Engagement with individual parents/carers of premature babies from five hospitals will be conducted through on-line or face to face focus groups to establish the problems or issues related to medicines, their relative importance to parents and carers and what types of information and educational resources or interventions they think would be helpful. These parents/carers will be invited to help design new targeted medicine support resources and then, once the resources have been produced, a separate group of parents will be asked to provide feedback on these resources in the home setting.
What are the possible benefits and risks of participating?
We do not expect there to be either any risks or benefits to you. We will not be collecting any participant identifiable information. The information collected will be used to explore the needs for medication safety resources in more detail. We hope that the resources developed will help parents/carers on the neonatal unit in the future.
Where is the study run from?
Alder Hey Children’s NHS Foundation Trust
When is the study starting and how long is it expected to run for?
January 2021 to May 2023
Who is funding the study?
Neonatal and Paediatric Pharmacists Group (NPPG Limited) (UK)
Who is the main contact?
Dr Louise Bracken, louise.bracken@alderhey.nhs.uk
Contact information
Scientific
Paediatric Medicines Research Unit
Clinical Research Division
1st Floor, Institute in the Park
Alder Hey Children’s NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom
 ORCID ID |
0000-0002-9632-2252 |
|---|---|
| Phone | +44 (0)151 252 5570 |
| louise.bracken@alderhey.nhs.uk |
Study information
| Study design | Observational qualitative |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Parent Co-designed Drug Information for Parents and Guardians taking Neonates Home |
| Study acronym | PADDINGToN Version 1.0 |
| Study hypothesis | The aim of this project is to work with parents/carers to co-design resources aimed at improving medication safety for those giving medications to neonates in the home environment. |
| Ethics approval(s) | Approved 01/07/2021, London - Bloomsbury Research Ethics Committee (MSE Meeting Rooms, Tottenham Court Road, London, W1T 1BB, UK; +44 (0)207 104 8063; bloomsbury.rec@hra.nhs.uk), ref: 21/LO/0351 |
| Condition | Medication safety for those giving medications to neonates in the home environment |
| Intervention | Work package 1 - Project management and coordination: including oversight of Study Management Group (SMG) and Research Delivery Group (RDG), protocol development, regulatory approvals (REC, HRA), site/investigator coordination, ongoing family communication, monitoring participant recruitment, risk management and budget management. Work package 2 - Stakeholder mapping, development of e-surveys and focus groups: Healthcare Professionals (HCPs) in national and international sites and parent/carer networks will be identified and contacted via an e-survey to identify issues faced by parents/carers of neonates and currently available or effective practices. On-line interviews or face to face focus groups with parents/carers of premature babies with experience of transitions of care will explore these themes. Work package 3 - Co-design of resources, evaluation and final dissemination: Caregivers willing to co-design educational and informative resources will be recruited, ensuring that content specificity, relevance and appropriate language are used in the new resources. A mixed methods evaluation with a different group of parent/carers will explore the utility (qualitative exploration), efficacy (quantitative evaluation of knowledge acquisition) and ease of implementation (including feedback on training needs) of the educational resources developed. HCPs will also be asked to evaluate the ease of implementation of resources. Effect size of outcomes may inform a larger effectiveness study. A multi-modal dissemination programme will ensure results are made available to stakeholders, including peer-reviewed publications. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Qualitative assessment of the usability and accessibility of resources available for parents/cares and healthcare professionals measured using e-surveys in July and focus groups in August 2021 2. Quantitative assessment of efficacy of the co-designed resources measured using a questionnaire circulated to a small group of HCPs to obtain feedback on training and support required to implement the resources Jan/Feb 2022 3. Ease of implementation – a questionnaire will be circulated to a small group of HCPs to obtain feedback on training and support required to implement the resources Jan/Feb 2022 4. An evaluation of the resource with a new group of parents/carers (approximately 10-15) to estimate: a. Utility - qualitative exploration (short semi-structured interviews) of usability, accessibility, language, detail, size, complexity, etc. b. Initial efficacy – Quantitative evaluation of knowledge acquisition Jan/Feb 2022 |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 06/01/2021 |
| Overall study end date | 31/05/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 185; UK Sample Size: 148 |
| Total final enrolment | 369 |
| Participant inclusion criteria | Parents/Carers (focus groups, co-designing resources, evaluation of resources): 1. Parents/Carers of babies receiving care on a neonatal unit in one of the 5 study sites who will require medication to be continued after discharge from hospital 2. Parents/Carers whose baby has recently been discharged from the neonatal unit at one of the 5 study sites and whose medication has continued after discharge 3. Arrangements will be made for Parents/Carers who do not have access to a smart phone or the internet to be able to contribute (eg face to face focus group may be offered where possible or phone credit will be provided) Health Care Professionals 4. Nurses, doctors, ANNPs or pharmacy staff providing neonatal care in any of the five study sites 5. Other HCPs identified from the staff stakeholder map identified in 7.2.1 (eg NPPG, Irish Neonatal Health Alliance) Neonatal parent support groups 6. Parents/Carers of babies who required medicines following discharge and are part of a neonatal parent support group identified in 7.2.1 (eg BLISS) 7. Parents/Carers of neonates whose babies were discharged from hospital within the last 5 years |
| Participant exclusion criteria | Parents/Carers 1. Parents/Carers who do not speak English (the resources will initially be developed in English and then we will apply for further funding to allow them to be translated into other languages) 2. Parents/Carers whose baby’s medication is likely to stop prior to discharge 3. Parents/Carers whose baby has a terminal diagnosis, a severe congenital abnormality or critical illness (unlikely to survive). 4. Parents/Carers unwilling to have audio-visual recording of focus group/interviews 5. Parents/Carers less than 16 years of age (the resources will initially be developed for parents/carers able to consent themselves, however, once the co-designed resources are available, we would like to explore utility in this group of parents) Health Care Professionals 6. HCPs not providing care to neonates requiring medicines |
| Recruitment start date | 01/06/2021 |
| Recruitment end date | 31/05/2022 |
Locations
Countries of recruitment
- England
- Ireland
- United Kingdom
Study participating centres
Eaton Road
Liverpool
L12 2AP
United Kingdom
Arrowe Park Road
Wirral
CH49 5PE
United Kingdom
Dublin
DO1 P5W9
Ireland
Crown Street
Liverpool
L8 7SS
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Sponsor information
Hospital/treatment centre
Alder Hey Hospital
Eaton Road
West Derby
Liverpool
L12 2AP
England
United Kingdom
| Phone | +44 (0)1512525570 |
|---|---|
| Lucy.Cooper@alderhey.nhs.uk | |
| Website | http://www.alderhey.nhs.uk/ |
"ROR" |
https://ror.org/00p18zw56 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | Current IPD sharing statement as of 23/05/2023: The datasets generated during and/or analysed during the current study are not expected to be made available because the sharing of datasets was not a provision within the protocol and the consent forms for the study’s different work packages. The provision states that data collected will only be included, after analysis, in study reports or publications. Previous IPD sharing statement: The datasets generated during and/or analysed during the current study are not expected to be made available |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (preprint) | 10/07/2022 | 13/07/2022 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Interim results article | Parents' experiences of administering medication to neonates at home | 27/10/2023 | 09/11/2023 | Yes | No |
Editorial Notes
09/11/2023: Publication reference added.
23/05/2023: The individual participant data (IPD) sharing statement has been changed.
18/05/2023: The following changes were made to the trial record:
1. The total final enrolment has been changed from 241 to 369.
2. The intention to publish date has been changed from 30/06/2023 to 30/09/2023.
3. The individual participant data (IPD) sharing statement and summary were added.
13/07/2022: Preprint reference added.
10/05/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2022 to 31/05/2023.
2. The total final enrolment was added.
3. The plain English summary was updated to reflect these changes.
20/08/2021: The ethics approval was added.
28/05/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
