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Allergy UK Research and Development Nurse Project (ALLUKN)

Primary Purpose

Allergy

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Nurse Led Allergy Clinic
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Allergy focused on measuring nurse led allergy clinic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • University Of Edinburgh Health CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Nurse led allergy clinic

Arm Description

nurse led allergy clinic

Outcomes

Primary Outcome Measures

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
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
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.
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.

Secondary Outcome Measures

Measure quality of life in patients using validated disease specific quality of life questionnaires Infants Dermatology Quality of Life Index IDQOL
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire specifically designed for infants with dermatology. Scoring system is via a 4 point satisfaction scale none (no impact) =0 severe = 4
Measure quality of life in patients validated disease specific quality of life questionnaires Mini Rhinitis Quality of Life Questionnaire (mini RQLQ)
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire to measure the impact of allergic rhinitis using a satisfaction scoring system no impact 0 - extreme = 4
Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Adult Form - (FAQLQ - AF)
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire specifically designed for adults with food allergy, using a specially designed nummular 6 point rating scoring system where 0== no impact 3= moderate impact and 6 = extreme impact on quality of life
Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Teenagers Form (FAQLQ - TF)
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire specifically designed for teenagers with food allergy. Scoring system using a specially designed nummular 6 point rating scoring system where 0== no impact 3= moderate impact and 6 = extreme impact on quality of life
Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality Of Life Questionnaire - Parents Form (FAQLQ - PF)
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire specifically designed for parents with children under 12 with food allergy. Scoring system using a specially designed nummular 6 point scoring system where 0== no impact 3= moderate impact and 6 = extreme impact on quality of life

Full Information

First Posted
May 22, 2017
Last Updated
January 31, 2019
Sponsor
University of Edinburgh
Collaborators
Allergy UK
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1. Study Identification

Unique Protocol Identification Number
NCT03826953
Brief Title
Allergy UK Research and Development Nurse Project
Acronym
ALLUKN
Official Title
Allergy UK Research and Development Nurse. Developing and Evaluating the Impact of a Nurse-led Primary Care-based Allergy Clinic in NHS Lothian: a Mixed Methods Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 4, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
Allergy UK

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study will consist of the development and delivery of a nurse led clinical intervention to provide allergy care in the community within the NHS Lothian primary care setting. The clinical intervention will see the allergy nurse provide clinical care to patients with a specified range of allergic conditions and provide diagnosis and immediate management where appropriate. The clinical component of the research project will consist of a pilot nurse led allergy clinic, provided by one specialist nurse twice a week across two different GP surgeries within NHS Lothian, GPs from across 12 practices will be encouraged to refer into the pilot allergy clinic. The referring health care professional will advise participants and their carers that the nurse led allergy clinic has been set up as part of a research project and participants will be asked if they wish to consent to take part in the research study. Feedback on the pilot clinic will be gathered to find out if the pilot clinic is acceptable to participants (satisfaction questionnaire), to find out if the clinic has made any improvement to quality of life (condition specific quality of life questionnaire) and if there is any cost impact (cost questionnaire). Participants The initial consultation - explanation of research project and written informed consent obtained. The nurse practitioner will: Take a thorough allergy clinical history including examination of the participant as necessary and identify what clinical care is required, Carry out any investigations that are required eg Skin prick testing to common food and aeroallergens. Give advice both written and verbal to support the management of allergies, including demonstration of medical devices e.g. adrenaline auto injectors, inhalers etc. Prescribe any necessary medication Provide a written summary of the consultation and any prescribed medication. Participants will complete a series of three questionnaires, satisfaction, condition specific quality of life and cost questionnaires. Follow up appointments where deemed appropriate will be conducted by telephone using a specified protocol. Where this is not appropriate face to face reviews will be arranged during clinic time. While short term follow-ups will be provided, there are no facilities to offer long term follow up for participants attending the allergy clinic under this pilot and all participants will return to their health care professional for follow up and long term management. If the participant has complex allergies or requires specialist intervention the participant will be advised that they will require referral into secondary care. As part of the research project an email support service will be set up to support the health care professionals involved in the project. The study will utilize a combination of qualitative and quantitative methods to evaluate the clinical intervention at baseline and at six weeks to determine the feasibility of the clinic and patient outcomes with this clinical intervention. The tools available to the researcher include a series of validated surveys including patient and clinician satisfaction surveys, condition specific quality of life and economic cost to patient. Interviews In addition face to face interviews will be offered to a subset of participants to enable further understanding of their perspective and experiences of the nurse-led allergy clinic. This will be to see if this intervention is feasible and improves patient care. The views of health care professionals and practice managers referring into this clinic will also be sought using a satisfaction questionnaire and qualitative interviews at 12 weeks after the start of the clinic and 10-12 months from the end of the project. Data on allergy will be requested from GP practices and NHS Information services Division (ISD) for quantitative analysis at baseline and at the end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
Keywords
nurse led allergy clinic

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nurse led allergy clinic
Arm Type
Other
Arm Description
nurse led allergy clinic
Intervention Type
Other
Intervention Name(s)
Nurse Led Allergy Clinic
Intervention Description
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.
Primary Outcome Measure Information:
Title
To find out if a nurse-led clinic in primary care is feasible measured using a validated satisfaction questionnaire,in patients
Description
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
Time Frame
3 year feasibility study
Title
To find out if a nurse-led clinic in primary care is feasible measured using a validated satisfaction questionnaire in primary care
Description
The questionnaire will measure health care professionals experience of referring patients into the clinic using the satisfaction questionnaire
Time Frame
3 year feasibility study
Title
To find out if a nurse-led clinic in primary care is feasible measured using a validated health economics survey
Description
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.
Time Frame
3 year feasibility study
Title
To find out if a nurse-led clinic in primary care is feasible measured using qualitative interviews
Description
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.
Time Frame
3 year feasibility study
Secondary Outcome Measure Information:
Title
Measure quality of life in patients using validated disease specific quality of life questionnaires Infants Dermatology Quality of Life Index IDQOL
Description
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire specifically designed for infants with dermatology. Scoring system is via a 4 point satisfaction scale none (no impact) =0 severe = 4
Time Frame
3 Years
Title
Measure quality of life in patients validated disease specific quality of life questionnaires Mini Rhinitis Quality of Life Questionnaire (mini RQLQ)
Description
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire to measure the impact of allergic rhinitis using a satisfaction scoring system no impact 0 - extreme = 4
Time Frame
3 Years
Title
Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Adult Form - (FAQLQ - AF)
Description
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire specifically designed for adults with food allergy, using a specially designed nummular 6 point rating scoring system where 0== no impact 3= moderate impact and 6 = extreme impact on quality of life
Time Frame
3 Years
Title
Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Teenagers Form (FAQLQ - TF)
Description
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire specifically designed for teenagers with food allergy. Scoring system using a specially designed nummular 6 point rating scoring system where 0== no impact 3= moderate impact and 6 = extreme impact on quality of life
Time Frame
3 Years
Title
Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality Of Life Questionnaire - Parents Form (FAQLQ - PF)
Description
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire specifically designed for parents with children under 12 with food allergy. Scoring system using a specially designed nummular 6 point scoring system where 0== no impact 3= moderate impact and 6 = extreme impact on quality of life
Time Frame
3 Years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof Schwarze
Phone
+44 0131 536 0800
Email
Jurgen.Schwarze@ed.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret Kelman
Phone
+44 0131 650 3469
Email
m.kelman@ed.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aziz Sheikh
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Edinburgh Health Centre
City
Edinburgh
ZIP/Postal Code
EH8 9AL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Grant
Phone
0131 650 2777
Email
jean.grant@nhslothian.scot.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19797601
Citation
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.
Results Reference
background
PubMed Identifier
25926095
Citation
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.
Results Reference
background
PubMed Identifier
20180792
Citation
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.
Results Reference
background
PubMed Identifier
25567768
Citation
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.
Results Reference
background
PubMed Identifier
15080802
Citation
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.
Results Reference
background
PubMed Identifier
24117436
Citation
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.
Results Reference
background
PubMed Identifier
19588053
Citation
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.
Results Reference
background
PubMed Identifier
19702674
Citation
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.
Results Reference
background
PubMed Identifier
16210065
Citation
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.
Results Reference
background
PubMed Identifier
19400899
Citation
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.
Results Reference
background
PubMed Identifier
26182682
Citation
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.
Results Reference
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PubMed Identifier
18081563
Citation
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.
Results Reference
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PubMed Identifier
26807213
Citation
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.
Results Reference
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PubMed Identifier
36036238
Citation
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.
Results Reference
derived

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Allergy UK Research and Development Nurse Project

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