Allergy UK Research and Development Nurse Project

NCT03826953 | Completed

• 1 other identifier: AC17008
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the research project is to develop, deliver and assess the feasibility of a nurse-led allergy clinic in primary care, taking into account population, geographical area and needs of healthcare in the area chosen. It is widely acknowledged that the majority of cases of mild to moderate allergy could be adequately dealt with in primary care, by a healthcare professional with the appropriate expertise and knowledge of allergy. The provision of allergy care in the community could potentially have a beneficial impact on health care and patient outcomes. The project will comprise the set up and delivery of a nurse led allergy clinic in primary care and use a mix of qualitative and quantitative methods to evaluate the feasibility of the clinic. This will include the use of a series of validated questionnaires e.g. satisfaction, condition specific quality of life and economic cost questionnaires, as well as face to face interviews. The research will collect data to see if this clinical intervention is feasible and allow audit of the clinical intervention. This will also enable the researchers to understand patients lived experiences of accessing allergy care and the effect of allergy on quality of life and impact of allergy care.

Conditions

Allergy

Keywords

nurse led allergy clinic

Outcome Measures

Primary Outcomes (4)

• To find out if a nurse-led clinic in primary care is feasible measured using a validated satisfaction questionnaire,in patients

  The questionnaire will measure the number of patients who had a positive or negative experience within the clinic using the satisfaction questionnaire at initial consultation then again at review

  3 year feasibility study

• To find out if a nurse-led clinic in primary care is feasible measured using a validated satisfaction questionnaire in primary care

  The questionnaire will measure health care professionals experience of referring patients into the clinic using the satisfaction questionnaire

  3 year feasibility study

• To find out if a nurse-led clinic in primary care is feasible measured using a validated health economics survey

  The Health economics survey will measure the cost of attending the clinic in terms of travel and loss of working or education hours required to attend the clinic.

  3 year feasibility study

• To find out if a nurse-led clinic in primary care is feasible measured using qualitative interviews

  Qualitative interviews will be used to find out patients and health care professionals experience of using the nurse led allergy clinic, interview will be transcribed and analysed using Nvivo.

  3 year feasibility study

Secondary Outcomes (5)

• Measure quality of life in patients using validated disease specific quality of life questionnaires Infants Dermatology Quality of Life Index IDQOL

  3 Years

• Measure quality of life in patients validated disease specific quality of life questionnaires Mini Rhinitis Quality of Life Questionnaire (mini RQLQ)

  3 Years

• Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Adult Form - (FAQLQ - AF)

  3 Years

• Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Teenagers Form (FAQLQ - TF)

  3 Years

• Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality Of Life Questionnaire - Parents Form (FAQLQ - PF)

  3 Years

Study Arms (1)

Nurse led allergy clinic

OTHER

nurse led allergy clinic

Other: Nurse Led Allergy Clinic

Interventions

Nurse Led Allergy Clinic OTHER

Project to investigate if it is feasible to establish a nurse-led primary care-based allergy clinic intervention in NHS Lothian, and to understand the acceptability and estimate the impact of this service on improving access and outcomes in patients with allergic conditions.WE will undertake a mixed-methods longitudinal evaluation of the community-based nurse-led allergy clinic.

Nurse led allergy clinic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All children, young people and adults who fit the selection criteria from across all the practices can be referred to the allergy clinic.
• All patients and parents / carers where appropriate must be deemed capable of giving informed consent to take part in the research project.
• Infants under two with suspected food allergy
• Infants under two with moderate-to-severe eczema not responding to standard treatment.
• Children and young people (up to 16 years of age) with suspected allergic rhinitis symptoms that are unresponsive to a combination of oral antihistamines and nasal steroids
• Young people and adults (from 16 years of age) with a history of anaphylaxis or suspected anaphylaxis

You may not qualify if:

• Over 2 years of age with delayed type food allergy presenting primarily with gastrointestinal symptoms
• Over 2 years of age with confirmed non IgE-mediated symptoms including food intolerances, coeliac disease etc.
• Single urticarial reactions without an obvious triggers
• Non-allergic chronic urticaria
• Drug allergy
• Well controlled allergic rhinitis, asthma or atopic eczema
• Mild-to-moderate atopic eczema without an obvious allergic trigger
• Localised insect sting reactions

Sponsors & Collaborators

• University of Edinburgh: lead
• Allergy UK: collaborator

Study Sites (1)

University Of Edinburgh Health Centre

Edinburgh, EH8 9AL, United Kingdom

Location

Related Publications (14)

• Anandan C, Gupta R, Simpson CR, Fischbacher C, Sheikh A. Epidemiology and disease burden from allergic disease in Scotland: analyses of national databases. J R Soc Med. 2009 Oct;102(10):431-42. doi: 10.1258/jrsm.2009.090027.

  PMID: 19797601 BACKGROUND

• Ben-Shoshan M, Soller L, Harrington DW, Knoll M, La Vieille S, Fragapane J, Joseph L, St Pierre Y, Wilson K, Elliott SJ, Clarke AE. Eczema in early childhood, sociodemographic factors and lifestyle habits are associated with food allergy: a nested case-control study. Int Arch Allergy Immunol. 2015;166(3):199-207. doi: 10.1159/000381829. Epub 2015 Apr 22.

  PMID: 25926095 BACKGROUND

• Cummings AJ, Knibb RC, King RM, Lucas JS. The psychosocial impact of food allergy and food hypersensitivity in children, adolescents and their families: a review. Allergy. 2010 Aug;65(8):933-45. doi: 10.1111/j.1398-9995.2010.02342.x. Epub 2010 Feb 22.

  PMID: 20180792 BACKGROUND

• Dhami S, Sheikh A. Estimating the prevalence of aero-allergy and/or food allergy in infants, children and young people with moderate-to-severe atopic eczema/dermatitis in primary care: multi-centre, cross-sectional study. J R Soc Med. 2015 Jun;108(6):229-36. doi: 10.1177/0141076814562982. Epub 2015 Jan 7.

  PMID: 25567768 BACKGROUND

• Gupta R, Sheikh A, Strachan DP, Anderson HR. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. 2004 Apr;34(4):520-6. doi: 10.1111/j.1365-2222.2004.1935.x.

  PMID: 15080802 BACKGROUND

• Jutel M, Angier L, Palkonen S, Ryan D, Sheikh A, Smith H, Valovirta E, Yusuf O, van Wijk RG, Agache I. Improving allergy management in the primary care network--a holistic approach. Allergy. 2013 Nov;68(11):1362-9. doi: 10.1111/all.12258. Epub 2013 Oct 11.

  PMID: 24117436 BACKGROUND

• Levy ML, Walker S, Woods A, Sheikh A. Service evaluation of a UK primary care-based allergy clinic: quality improvement report. Prim Care Respir J. 2009 Dec;18(4):313-9. doi: 10.4104/pcrj.2009.00042.

  PMID: 19588053 BACKGROUND

• MacKenzie H, Roberts G, van Laar D, Dean T. Teenagers' experiences of living with food hypersensitivity: a qualitative study. Pediatr Allergy Immunol. 2010 Jun;21(4 Pt 1):595-602. doi: 10.1111/j.1399-3038.2009.00938.x. Epub 2009 Aug 21.

  PMID: 19702674 BACKGROUND

• Pereira B, Venter C, Grundy J, Clayton CB, Arshad SH, Dean T. Prevalence of sensitization to food allergens, reported adverse reaction to foods, food avoidance, and food hypersensitivity among teenagers. J Allergy Clin Immunol. 2005 Oct;116(4):884-92. doi: 10.1016/j.jaci.2005.05.047.

  PMID: 16210065 BACKGROUND

• Punekar YS, Sheikh A. Establishing the incidence and prevalence of clinician-diagnosed allergic conditions in children and adolescents using routinely collected data from general practices. Clin Exp Allergy. 2009 Aug;39(8):1209-16. doi: 10.1111/j.1365-2222.2009.03248.x. Epub 2009 Apr 17.

  PMID: 19400899 BACKGROUND

• Tejedor-Alonso M A, Moro-Moro M, Mugica-Garcia MV. Epidemiology of Anaphylaxis: Contributions From the Last 10 Years. J Investig Allergol Clin Immunol. 2015;25(3):163-75; quiz follow 174-5.

  PMID: 26182682 BACKGROUND

• Scadding GK, Durham SR, Mirakian R, Jones NS, Leech SC, Farooque S, Ryan D, Walker SM, Clark AT, Dixon TA, Jolles SR, Siddique N, Cullinan P, Howarth PH, Nasser SM; British Society for Allergy and Clinical Immunology. BSACI guidelines for the management of allergic and non-allergic rhinitis. Clin Exp Allergy. 2008 Jan;38(1):19-42. doi: 10.1111/j.1365-2222.2007.02888.x.

  PMID: 18081563 BACKGROUND

• Smith HE, Wade J, Frew AJ. What proportion of adult allergy referrals to secondary care could be dealt with in primary care by a GP with special interest? Clin Transl Allergy. 2016 Jan 21;6:3. doi: 10.1186/s13601-016-0091-1. eCollection 2015.

  PMID: 26807213 BACKGROUND

• Hammersley V, Kelman M, Morrice L, Kendall M, Mukerjhee M, Harley S, Schwarze J, Sheikh A. Mixed-methods evaluation of a nurse-led allergy clinic model in primary care: Feasibility trial. Clin Transl Allergy. 2022 Aug;12(8):e12180. doi: 10.1002/clt2.12180.

  PMID: 36036238 DERIVED

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Aziz Sheikh

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is to determine the feasibility of a nurse led allergy clinic, delivered by specialist allergy nurse in primary care, using a hub and spoke model for the delivery of the clinic, the hub being the 'host' centre of GP practice and the spokes being the local / neighbouring GP practices that refer into the 'host' centre. Participants will be identified and recommended through their usual health care provider and referred into the clinic. Data will be collected through a mixed methods approach using questionnaires, interviews and national and locally held data to evaluate the effectiveness of the clinic.

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: February 1, 2019
• Study Start: July 4, 2017
• Primary Completion: December 31, 2020
• Study Completion: February 28, 2021
• Last Updated: May 1, 2024

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)