About this trial
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting approximately 10% of the adult population globally. COPD is recognised to be an important area of focus, as part of one of the healthcare challenges defined by the Office of Life Sciences. Patients with COPD often experience exacerbations which are triggered episodes leading to disease worsening. Exacerbations are associated with increased morbidity and a risk of mortality.
Severe exacerbations, where patients are hospitalised, are of particular concern to patients, carers and healthcare givers. The National Institute for Health and Care Excellence (NICE) recommends that hospital clinicians looking after patients with COPD should provide rescue packs (a course of prednisolone and antibiotics) and a basic management plan to patients on discharge. It is recognised that there is a high-risk 90-day period to patients with COPD following discharge from hospital, where there is a 43% risk of readmission and a 12% risk of mortality; however repeated national audit data has shown that, despite NICE recommendations this high risk of readmission and mortality has not changed.
A multicentre randomised clinical trial of 1400 patients will be conducted in 30 acute NHS trusts. This will test the hypothesis that a self-supported rescue pack management plan consisting of rescue packs + written self-management plan + twice weekly telephone/text symptom alert assessments in the high-risk 90-day period is better than standard care in reducing 90-day readmission by 20%. If successful, this intervention would be rapidly implementable, improve patient clinical outcomes and have a cost saving of approximately £350 million per annum.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 40 years
Individuals admitted to hospital with COPD exacerbation who have recently been discharged (discharged from ongoing support from secondary care team which includes hospital and virtual wards). Admission is defined as an episode in which a patient with an exacerbation of COPD is admitted to a ward and has stayed in hospital for 4 hours or more, including Emergency Medicine Centres, Medical Admission Units, Clinical Decision Units, short stay wards or similar but excludes patients treated transiently before being discharged from Emergency Department.
Ability to provide written informed consent
Disqualifiers
Individuals who require invasive ventilation during the hospital admission
Patients who have an expected survival of less than 90 days
Patients with signs of new consolidation on chest X-ray (if available).
Individuals who have been discharged to a residential or nursing home to residential or nursing home.
Trial design
Parallel
Treatments tested in this trial
Supported rescue pack
Combination product1\) a rescue pack (prednisolone and antibiotics for 5 days); 2) a written rescue pack management plan based on the Asthma-Lung UK plan; and 3) twice-weekly automated telephone symptom reminder calls for 90 days (with preferred language as needed). The reminder phone calls (to home telephone or mobile) will ask questions aligned to the written management plan
Treatment groups
Trial outcomes
Primary outcomes
Time to first all-cause readmission within 90 days of discharge
Time to first all-cause readmission within 90 days of discharge.
Secondary outcomes
Time to and frequency of COPD-related readmissions at 30 days
Time to and frequency of COPD-related readmissions at 30 days post index discharge.
Time to and frequency of COPD-related readmissions at 90 days
Time to and frequency of COPD-related readmissions at 90 days post index discharge.
Days alive and out of hospital at day 90
Days alive and out of hospital at day 90 post index discharge.
Time to and frequency of all COPD exacerbations at day 30
Time to and frequency of all COPD exacerbations at day 30 post index discharge.
Sponsors and contacts
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Guy's and St Thomas' NHS Foundation Trust
Lead sponsor
King's College London
Collaborator
University College, London
Collaborator
Imperial College London
Collaborator
University of Cambridge
Collaborator
University of Southampton
Collaborator
University of Nottingham
Collaborator
University of Leicester
Collaborator
Frimley Health NHS Foundation Trust
Collaborator
Newcastle University
Collaborator
University of Bristol
Collaborator
Asthma and Lung UK
Collaborator