Feasibility study of a multicentre cluster randomised control trial to investigate the clinical and cost-effectiveness of a structured diagnostic pathway in primary care for chronic breathlessness: protocol paper

Abstract

IntroductionChronic breathlessness is a common and debilitating symptom, associated with high healthcare use and reduced quality of life. Challenges and delays in diagnosis for people with chronic breathlessness frequently occur, leading to delayed access to therapies. The overarching hypothesis is a symptom-based approach to diagnosis in primary care would lead to earlier diagnosis, and therefore earlier treatment and improved longer-term outcomes including health-related quality of life. This study aims to establish the feasibility of a multicentre cluster randomised controlled trial to assess the clinical and cost-effectiveness of a structured diagnostic pathway for breathlessness in primary care.Methods and analysisTen general practitioner (GP) practices across Leicester and Leicestershire will be cluster randomised to either a structured diagnostic pathway (intervention) or usual care. The structured diagnostic pathway includes a panel of investigations within 1 month. Usual care will proceed with patient care as per normal practice. Eligibility criteria include patients presenting with chronic breathlessness for the first time, who are over 40 years old and without a pre-existing diagnosis for their symptoms. An electronic template triggered at the point of consultation with the GP will aid opportunistic recruitment in primary care. The primary outcome for this feasibility study is recruitment rate. Secondary outcome measures, including time to diagnosis, will be collected to help inform outcomes for the future trial and to assess the impact of an earlier diagnosis. These will include symptoms, health-related quality of life, exercise capacity, measures of frailty, physical activity and healthcare utilisation. The study will include nested qualitative interviews with patients and healthcare staff to understand the feasibility outcomes, explore what is ‘usual care’ and the study experience.Ethics and disseminationThe Research Ethics Committee Nottingham 1 has provided ethical approval for this research study (REC Reference: 19/EM/0201). Results from the study will be disseminated by presentations at relevant meetings and conferences including British Thoracic Society and Primary Care Respiratory Society, as well as by peer-reviewed publications and through patient presentations and newsletters to patients, where available.Trial registration numberISRCTN14483247.

Diagnostic delays for breathlessness in primary care: a qualitative study to investigate current care and inform future pathways

“…Semi-structured interviews were conducted between November 2019 and October 2021 with participants enrolled in a mixed-method feasibility cluster randomised controlled trial (cRCT) in England called Breathlessness DiagnosE Early in Primary care (Breathe DEEP) (ISRCTN14483247). 29 The Breathe DEEP trial involved 10 GP practices across Leicester and Leicestershire, which were cluster randomised to either a structured diagnostic pathway (intervention) or to usual care. The structured diagnostic pathway included a panel of investigations, completed within 2 months of consultation with the GP for breathlessness.…”

“…30 Eligible patients were >40 years old, breathless for longer than 2 months, and presenting for the first time, with no previous diagnoses for their breathlessness. 29 Semi-structured interviews were conducted with clinicians from 10 practices enrolled in the cRCT, who were not necessarily directly involved in the care of the patients interviewed.…”

ERS International Congress 2022: highlights from the Respiratory Clinical Care and Physiology Assembly

“…The ageing population and its burden on health-care systems warrant early detection of patients at risk of functional decline and mortality. [40]. Forty-eight patients were included in ten GP practices.…”

“…Finally, G. Doe and co-workers (Leicester, UK) presented a feasibility study investigating the impact of a structured diagnostic pathway designed to confirm or exclude the five most common causes of chronic breathlessness in patients over 40 years old: COPD, anxiety, anaemia, heart failure and obesity/deconditioning [ 40 , 41 ]. 48 patients were included from 10 GP practices [ 41 ].…”

Comparing research recruitment strategies to prospectively identify patients presenting with breathlessness in primary care

“…The first method (Strategy 1) for a primary care breathlessness cohort study used weekly searches for new breathlessness Read codes in the electronic patient record (EPR), followed by a mail out of study information to identified patients at 14 GP practices. The second method (Strategy 2) implemented an opportunist approach using an electronic template on the EPR, triggered at the point of consultation by either breathlessness-free text or Read codes at 10 GP practices 8 . The template (Fig.…”