Diagnostic pathways for patients with chronic breathlessness.
Research type
Research Study
Full title
A feasibility study of a multi-centre cluster randomised controlled trial (RCT) to investigate whether a new diagnostic pathway is clinically and cost-effective for older adults presenting with chronic breathlessness.
IRAS ID
261499
Contact name
Rachael Evans
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
6 years, 2 months, 1 days
Research summary
This is a feasibility study to understand what the practicalities are of running a larger trial. The larger trial will be a cluster randomised controlled trial to investigate a novel diagnostic pathway, to include a panel of simple early investigations, for patients with breathlessness in primary care. We will aim to determine the cluster and sample size required for the larger trial.
This study will aim to recruit GP practices form Leicestershire, Leicester and Northamptonshire who will be randomised to an intervention or usual care group. The GPs in the intervention group will use the new diagnostic pathway and early investigations. The usual care GP group will continue with their normal practice. Usual care will be standardised by directing clinicians to the NICE Clinical Knowledge Summary on Breathlessness (2017) . The Clinical Knowledge Summary advocates the same investigations as we describe in the Diagnostic Pathway but without a stipulated timeframe.
Time to diagnosis will be recorded.Patients aged over 40 years old attending a GP consultation for breathlessness lasting longer than two months will be invited to take part in the study.
Participants will be asked to attend two research visits at the Biomedical Research Centre at Glenfield Hospital where outcome measures such as walk tests, balance and strength, body composition, physical activity and health status (using questionnaires) will be collected. There will also be patient and GP interviews to help understand their experiences of taking part in the study and help inform the larger trial.The overall aim is to establish if a new diagnostic pathway for chronic breathlessness is clinically and cost effective.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
19/EM/0201
Date of REC Opinion
5 Aug 2019
REC opinion
Further Information Favourable Opinion