Feasibility of a cluster trial for identifying OA
Research type
Research Study
Full title
Feasibility study to inform a cluster randomized trial of the clinical effectiveness of a screening tool to identify occupational asthma
IRAS ID
129572
Contact name
Gareth Walters
Contact email
Sponsor organisation
University of Birmingham
Research summary
This is a feasibility study for a cluster trial that aims to measure the clinical effectiveness of a screening tool for occupational asthma (OA) in primary care. The feasibility study will test the assumptions required for the power calculation of the cluster trial, as well as willingness of healthcare professionals to use the screening tool, and availability of trial baseline and outcome data. We will recruit at least 4 primary care practices to the feasibility study, from the Central England Primary Care Research Network. Each practice will embed the screening tool in their electronic patient consultation database, as a template to be used for clinical reviews with asthma patients by GPs and practice nurses. These might be routine reviews or urgent consultations for asthma exacerbations. The screening tool consists of a prompt for healthcare workers to ask an asthmatic patient their occupation and whether their asthma symptoms are better away from work at the weekend, or on holiday. These questions have a high sensitivity for identifying cases of OA. At the outset we will collect practice level data (for example: list size, number of registered asthmatics)and data on registered working-age asthmatics (for example: age, sex, current treatment) to test the assumptions required to calculate sample size. The screening tool will be embedded for 4 months at which point outcome data for the trial will be collected (for example: number of asthmatics undertaking review, latency of symptoms to screening event), in order to test availability of data and the data collection procedure only. No trial outcome analysis will be undertaken as part of this feasibility study.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
13/YH/0291
Date of REC Opinion
14 Aug 2013
REC opinion
Favourable Opinion