Clinical trial NCT03826953: Allergy UK Research and Development Nurse Project
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
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Keywords: nurse led allergy clinic
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Allergy UK
First posted: 2019-02-01
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: To find out if a nurse-led clinic in primary care is feasible measured using a validated satisfaction questionnaire,in patients
timeFrame: 3 year feasibility study
measure: To find out if a nurse-led clinic in primary care is feasible measured using a validated satisfaction questionnaire in primary care
timeFrame: 3 year feasibility study
measure: To find out if a nurse-led clinic in primary care is feasible measured using a validated health economics survey
timeFrame: 3 year feasibility study
measure: To find out if a nurse-led clinic in primary care is feasible measured using qualitative interviews
timeFrame: 3 year feasibility study
Secondary outcomes:
measure: Measure quality of life in patients using validated disease specific quality of life questionnaires Infants Dermatology Quality of Life Index IDQOL
timeFrame: 3 Years
measure: Measure quality of life in patients validated disease specific quality of life questionnaires Mini Rhinitis Quality of Life Questionnaire (mini RQLQ)
timeFrame: 3 Years
measure: Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Adult Form - (FAQLQ - AF)
timeFrame: 3 Years
measure: Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Teenagers Form (FAQLQ - TF)
timeFrame: 3 Years
measure: Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality Of Life Questionnaire - Parents Form (FAQLQ - PF)
timeFrame: 3 Years
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University Of Edinburgh Health Centre
Study officials:
affiliation: University of Edinburgh
name: Aziz Sheikh
role: PRINCIPAL_INVESTIGATOR
References:
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