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 standard care for patients with modifiable high-risk chronic obstructive pulmonary disease with or without a current diagnosis (PREVAIL).

  • IRAS ID

    295908

  • Contact name

    Francis Appiagyei

  • Contact email

    francis@opri.sg

  • 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 a condition that affects over 250 million people world-wide. In the UK, COPD accounts for over £1.3 billion in healthcare costs. Many people with COPD do not realise they have it. Without diagnosis and appropriate treatment, the symptoms usually get progressively worse. There may also be periods when they get suddenly worse, known as a flare-up or exacerbation.

    The CONQUEST quality improvement (QI) programme has been developed by doctors and health experts to help practices find and improve the treatment for patients with a high-risk of exacerbations for COPD including those yet to be diagnosed. We have referred to these patients as having modifiable high-risk COPD.

    PREVAIL will be assessing how effective the CONQUEST programme is at improving treatment and reducing exacerbations in diagnosed and undiagnosed patients with modifiable high-risk COPD. 126 practices will take part. Half of practices will receive the CONQUEST programme and the other half will not but continue with their usual patient care. Practices using CONQUEST will be given:
    • Support with finding modifiable high-risk COPD patients
    • QI reports which show where patients care and treatments can be improved
    • Pharmacists or nurses to help see patients and get them under control to reduce exacerbations.

    PREVAIL is planned to start in 2021 and end in 2026. Each practice will spend about 3 years in the study. The study is a cluster randomised trial, which means the participants are the GP practices (not patients). There are no study visits involved for patients.

    De-identified data will be extracted from each practices' medical records at the beginning of the study and regularly until the end of the study. All data will be stored in the ethically approved Optimum Patient Care Research Database (https://opcrd.co.uk , REC ref: 20/EM/0148). Any data shared with researchers will be anonymised.

  • REC name

    East of England - Cambridge South Research Ethics Committee

  • REC reference

    21/EE/0196

  • Date of REC Opinion

    7 Sep 2021

  • REC opinion

    Unfavourable Opinion