Pragmatic evaluation of a QI programme for modifiable high-risk COPD
Research type
Research Study
Full title
A 3-year cluster randomised controlled trial of the impact of a quality improvement and clinical decision support package versus usual care for patients with modifiable high-risk chronic obstructive pulmonary disease with or without a current diagnosis.
IRAS ID
295908
Contact name
Francis Appiagyei
Contact email
Sponsor organisation
Observational & Pragmatic Research International Ltd.
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Chronic obstructive pulmonary disease (COPD) is the third biggest cause of death and incurs substantial healthcare costs. Clinical diagnosis is often delayed and approximately two thirds of those with COPD are undiagnosed, resulting in delayed treatment and reduced quality life. Furthermore, suboptimal treatment of diagnosed patients can lead to insufficient symptom management. The main symptoms of COPD are breathlessness, wheeze and chronic cough. COPD patients can experience periods when these symptoms suddenly worsen, known as flare-ups or exacerbations, which may result in hospitalisation and disease progression.
Prior research demonstrates the ability to diagnose COPD earlier within primary care, but the effect on patient health outcomes is unknown. A quality improvement programme (the intervention) has been developed, aiming to identify COPD patients at high risk of exacerbations and improve their treatment. The proposed trial will assess the effectiveness of the intervention for reducing future exacerbations, compared to usual care. The trial population will include patients with existing COPD diagnoses and those newly identified with the disease, who have a high risk of future exacerbations and potential for increased COPD medication (referred to as ‘modifiable high-risk COPD’).
126 GP practices in the UK will participate in the trial; half of them will be randomly allocated to receive the intervention and half will continue to provide usual patient care. We estimate that each practice will enrol 12 patients, giving a total of 1512 patients included in the trial. As part of the quality improvement programme, practices in the intervention group will be responsible for identifying relevant patients and optimising their COPD treatment based on clinical recommendations; as such, there will be no specific research study visits. Trial analyses will be conducted using anonymised patient data from GP practice electronic medical records, stored in the Optimum Patient Care Research Database (https://opcrd.co.uk, REC ref: 20/EM/0148).
REC name
East Midlands - Derby Research Ethics Committee
REC reference
21/EM/0252
Date of REC Opinion
24 Nov 2021
REC opinion
Further Information Favourable Opinion