A pharmacist-led parent/carer education program to support the management of atopic eczema in children
| ISRCTN | ISRCTN17846245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17846245 |
| IRAS number | 270218 |
| Secondary identifying numbers | CPMS 45309, IRAS 270218 |
- Submission date
- 26/01/2021
- Registration date
- 01/02/2021
- Last edited
- 12/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Atopic eczema (atopic dermatitis) is the most common form of eczema, a condition that causes the skin to become itchy, dry and cracked. Atopic eczema is more common in children, often developing before their first birthday. But it may also develop for the first time in adults. It's usually a long-term (chronic) condition, although it can improve significantly, or even clear completely, in some children as they get older.
Patient education plays a key role in the successful management of atopic eczema. While Government policy supports the role of pharmacists in those with long-term conditions such as atopic eczema, there is only weak evidence that educational interventions by pharmacists can reduce the severity of eczema.
This study will investigate the impact on disease severity following an educational intervention provided by general medical practice-based, clinical pharmacists to parents/carers of children with atopic eczema. A modified Person-centred Dermatology Self-care Index (PEDESI) tool will be used by pharmacists to assess parents’/carers’ knowledge and understanding of atopic eczema and its management, following which the pharmacists will provide educational advice where appropriate. Disease severity will be measured using the Patient-Oriented Eczema Measure (POEM) score at baseline.
The study has the potential to demonstrate the valuable contribution to care of patients with atopic eczema by practice-based pharmacists. If successful, the results would serve as an exemplar of best practice that can be more widely adopted within the NHS.
Who can participate?
Children aged between six months and six years of age with a diagnosis of atopic eczema, identified through searches of the general medical practice database, will be included.
What does the study involve?
Children and their parents will be invited to a consultation with the clinical practice-based pharmacist. During the consultation, pharmacists will assess parent/carer's knowledge and understanding of AE and ask participants to complete a specific eczema disease severity tool. At a follow-up appointment, the pharmacists will re-check participant knowledge and understanding of eczema and repeat the eczema severity tool to assess for any changes.
In addition, telephone interviews will be conducted with a sample of parents, focusing on their views of the usefulness, acceptability, and impact of the intervention.
What are the possible benefits and risks of participating?
Benefits: We hope that after receiving the information and advice from the pharmacist that participants will be more confident at managing their child’s eczema. Participants will also be helping to evaluate whether this type of service should become routine practice for pharmacists working within GP practices.
Risks: It is not anticipated that there will be any disadvantages or risks associated with the study. However, if participants experience any problems or are unclear about the study, they are encouraged to contact the pharmacist at the surgery who can hopefully answer any of their questions.
Where is the study run from?
Rotherham, Doncaster, and South Humber NHS Foundation Trust (RDaSH) (UK)
When is the study starting and how long is it expected to run for?
March 2020 to March 2022 (updated 19/08/2021, previously: August 2021)
Who is funding the study?
FONTUS HEALTH LTD (UK)
Who is the main contact?
1. Dr Rod Tucker (scientific), rodtucker.tucker@gmail.com
2. Miss Jeannie McKie (public), j.mckie@nhs.net
Contact information
Scientific
Yule Lodge
Cliff Road
Atwick
YO25 8DF
United Kingdom
| Phone | +44 (0)7969155658 |
|---|---|
| rodtucker.tucker@gmail.com |
Public
Grounded Research
Rotherham Doncaster & South Humber NHS Trust
Almond Tree Court
Woodfield Park
Doncaster
DN4 8QP
United Kingdom
 ORCID ID |
0000-0003-4327-9681 |
|---|---|
| Phone | +44 (0)7818 560176 |
| j.mckie@nhs.net |
Study information
| Study design | Interventional randomized controlled trial with qualitative follow up |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | ISRCTN17846245_PIS_v1.2_15June2020.pdf |
| Scientific title | Evaluation of the impact on disease severity of treatment-related educational advice delivered by general practice-based clinical pharmacists to the parents/carers of children with atopic eczema: a randomised study |
| Study hypothesis | The hypothesis for the study is that as the experts in medicines, pharmacists play an important role in supporting patients (or parents in this case) to optimise the use of their medicines. Thus, the research question is “does education support on the management of atopic eczema delivered by practice-based pharmacists to the parents/carers of children with atopic eczema, lead to improvement in both knowledge and disease outcomes”. |
| Ethics approval(s) | Approved 29/07/2020, East of England - Cambridgeshire and Hertfordshire REC (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8265; cambsandherts.rec@hra.nhs.uk), ref: 20/EE/0132 |
| Condition | Dermatitis and eczema |
| Intervention | In the present study, eligible participants will be identified through a search of the GP practice database. Participants will be randomised at the practice level and for those assigned to the intervention group, a letter of invite, consent form and information sheet, will be sent to the parent/carer asking them to contact the practice pharmacist to arrange a mutually convenient time for an initial appointment. Participants assigned to the control groups will be sent the same information as the intervention group and a validated eczema severity tool, the patient orientated eczema measure (POEM) which they will be asked to complete on behalf of their child and return this to the practice pharmacist. They will be informed that the pharmacist will contact them in due course to arrange an appointment to provide advice and information on their child's eczema. During the initial appointment for participants assigned to the intervention group, the clinical pharmacist will assess their knowledge and understanding of AE and its management using the Person-centred Dermatology self-care index (PeDeSI) which is a validated tool designed to explore patients' knowledge and understanding of a skin condition and its management. Participants will also be asked to complete the same POEM tool which was sent to those in the control arm. The verbal advice provided by the pharmacists will be supplemented with relevant written information. The intervention group will be asked to return for a follow-up appointment 4 weeks later at which stage the pharmacists will re-assess participants' knowledge and understanding and ask them to complete a second POEM tool. The participants in the control arm will be sent an invitation to an appointment with the clinical pharmacist approximately 4 weeks after returning the eczema severity score. At this appointment, the clinical pharmacist will assess participants understanding of the disease and its management using the PeDeSI tool and provide the same educational advice and information given to the intervention group during their initial consultation. We will then compare changes in the POEM scores between both groups at the same time, i.e. at the follow-up appointment (intervention group) and initial appointment (control group) as this will provide a measure of the impact of the educational input from the pharmacists. Patients/carers of the children will be contacted after completion of the study for a short telephone interview to gather their thoughts and experiences of the pharmacist consultation. |
| Intervention type | Behavioural |
| Primary outcome measure | Eczema severity measured using Patient-Oriented Eczema Measure (POEM) score at baseline and 4 weeks |
| Secondary outcome measures | Eczema care knowledge and understanding among parents/carers measured using the Person-centred dermatology self care index (PeDesi) at baseline and 4 weeks |
| Overall study start date | 06/03/2020 |
| Overall study end date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Planned Sample Size: 118; UK Sample Size: 118 |
| Total final enrolment | 32 |
| Participant inclusion criteria | 1. Parents of children aged 6 months - 6 years with a diagnosis of atopic eczema made by a GP or an appropriately qualified health care professional recorded in their medical notes 2. Children currently prescribed (prescriptions issued for the previous three months) one or more of the following treatments: 2.1. Any emollient products e.g. creams, ointments, bathing products, etc. 2.2. Topical steroids 2.3. Topical immunomodulators |
| Participant exclusion criteria | 1. Parents (or carers) without adequate spoken and written English, as determined by the pharmacist, will be excluded as the study does not have sufficient funding to allow for the provision of an interpreter or for the education information to be translated into other languages 2. Children under the care of a dermatologist or other dermatology specialist 3. Children attending any specialist nurse-led eczema clinic Children in the above categories are excluded because it is assumed that they will have received sufficient educational support and are therefore unlikely to benefit from additional advice |
| Recruitment start date | 01/02/2021 |
| Recruitment end date | 31/03/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
49 Goodhart Rd
Hull
HU7 4DW
United Kingdom
2 Diadem Grove
Hull
HU9 4AL
United Kingdom
1 Amos Dr
Pocklington
York
YO42 2BS
United Kingdom
Sponsor information
Hospital/treatment centre
St. Catherine's House
St. Catherine's Hospital
Tickhill Road
Doncaster
DN4 8QN
England
United Kingdom
| Phone | +44 (0)1302 798456 |
|---|---|
| Rdash.groundedresearch@nhs.net |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1.2 | 15/06/2020 | 01/02/2021 | No | Yes |
| Protocol file | version v1.2 | 02/06/2020 | 01/02/2021 | No | No |
| Protocol file | version 1.4 | 22/10/2021 | 07/02/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Plain English results | 12/04/2024 | No | Yes | ||
| Results article | 01/03/2024 | 12/04/2024 | Yes | No |
Additional files
Editorial Notes
12/04/2024: Publication file and plain English results files added.
11/07/2023: The following changes were made to the study record:
1. The overall study end date was changed from 01/03/2022 to 31/03/2022.
2. The intention to publish date was changed from 01/08/2022 to 01/09/2023.
3. Total final enrolment added.
07/02/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2021 to 31/03/2022.
2. Uploaded protocol (not peer-reviewed) as an additional file.
09/09/2021: The study contact has been updated and the plain English summary has been updated accordingly.
19/08/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2021 to 31/12/2021.
2. The overall end date was changed from 01/08/2021 to 01/03/2022.
3. The plain English summary was updated to reflect these changes.
01/02/2021: The participant information sheet was uploaded as an additional file. Uploaded protocol (not peer reviewed) Version 1.2 02 June 2020.
26/01/2021: Trial’s existence confirmed by National Institute for Health Research (NIHR).
