An interventional study of Nurse Led Allergy Clinic in Allergy, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by University of Edinburgh · Not applicable, Interventional, and Health services research
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.
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:
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.
1,925 studies on the registry are indexed under Hypersensitivity; 261 are open to participants now.
This study's enrollment of 250 is above the median of 58 across 1,391 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →University of Edinburgh is the lead sponsor of 403 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
nurse led allergy clinic
Other: Nurse Led Allergy Clinic
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.
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 3 year feasibility study
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
Time frame: 3 Years
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
Time frame: 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)
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
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
Time frame: 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)
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
Plan to share: No
Ran from Jul 2017 to primary completion in Dec 2020, 41 months.
Of 423 non-industry interventional studies with no phase under Hypersensitivity, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's 41 months is above that.
Counting every sponsor, half of 481 studies reached it within 13 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.