RecruitingPhase 3NCT06347536

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


Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrollment

1,400 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether providing people with COPD (chronic obstructive pulmonary disease) with a pre-packed "rescue kit" of medications to take at the first signs of a flare-up — after being discharged from hospital — reduces their chances of being readmitted. Patients use the kit at home and are guided on when and how to use it. **You may be eligible if...** - You are 40 or older - You were recently hospitalized for a COPD flare-up and have been discharged from hospital or virtual ward follow-up - Your hospital stay involved being admitted to a ward for at least 4 hours - You are able to provide written consent **You may NOT be eligible if...** - You required invasive mechanical ventilation (a breathing machine through a tube in your throat) during your hospital stay - Your life expectancy is less than 90 days due to a serious illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTSupported 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(34)

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

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