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RECRUITINGPhase 3INTERVENTIONAL

Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease

Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease: An Open-label Multicenter Randomised Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

COMBINATION_PRODUCT

Supported rescue pack

1\) 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

Locations (20)

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