Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease
Recruiting · NCT06347536 · Interventional (participants receive a specific treatment) · Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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.
- Individuals who are unable to manage a supported self-management plan.
- Individuals with no access to telephone.
- Individuals who are already taking part in an interventional trial.
- Previous participation in the RAPID trial.
Where it is running
34 locations listed.
- Barnsley Hospital NHS Foundation Trust - Barnsley, United Kingdom
- University Hospitals Birminham NHS Foundation Trust - Birmingham, United Kingdom
- Blackpool Teaching Hospitals - Blackpool, United Kingdom
- Bradford Teaching Hospitals NHS Foundation Trust - Bradford, United Kingdom
- University Hospitals Sussex NHS Foundation Trust - Brighton, United Kingdom
- North Bristol University Trust - Bristol, United Kingdom
- County Durham and Darlington NHS Foundation Trust - Durham, United Kingdom
- Gateshead NHS Foundation Trust - Gateshead, United Kingdom
- East Suffolk and North Essex Foundation Trust - Ipswich, United Kingdom
- University Hospitals of Morecambe Bay NHS Foundation Trust - Lancaster, United Kingdom
- University Hospitals of Leicester NHS Trust - Leicester, United Kingdom
- Cardiff and Vale University Health Board - Llandough, United Kingdom
- Guy's and St Thomas' NHS Foundation Trust - London, United Kingdom
- Imperial College Healthcare NHS Trust - London, United Kingdom
- King's College Hospital - London, United Kingdom
- London North West University Healthcare NHS Trust - London, United Kingdom
- Royal Free London NHS Foundation Trust - London, United Kingdom
- Maidstone and Tunbridge Wells NHS Trust - Maidstone, United Kingdom
- South Tees NHS Foundation Trust - Middlesbrough, United Kingdom
- Milton Keynes University Hospital NHS Foundation Trust - Milton Keynes, United Kingdom
- Newcastle Upon Tyne Hospitals NHS Foundation Trust - Newcastle upon Tyne, United Kingdom
- Nottingham University Hospitals Trust - Nottingham, United Kingdom
- Oxford University Hospitals NHS Foundation Trust - Oxford, United Kingdom
- Rotherham NHS Foundation Trust - Rotherham, United Kingdom
- University Hospital Southampton NHS Foundation Trust - Shirley, United Kingdom
- Frimley Health NHS Foundation Trust - Slough, United Kingdom
- South Tyneside and Sunderland NHS Trust - South Shields, United Kingdom
- Southport and Formby District General Hospital - Southport, United Kingdom
- Stockport NHS Foundation Trust - Stockport, United Kingdom
- North Tees and Hartlepool NHS Foundation Trust - Stockton-on-Tees, United Kingdom
- Sherwood Forest Hospitals NHS Foundation Trust - Sutton in Ashfield, United Kingdom
- Somerset Foundation Trust - Taunton, United Kingdom
- Whiston Hospital - Whiston, United Kingdom
- Somerset Foundation Trust - Yeovil, United Kingdom