Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease
RAPID
2 other identifiers
interventional
1,400
1 country
34
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2025
Typical duration for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2024
CompletedFirst Posted
Study publicly available on registry
April 4, 2024
CompletedStudy Start
First participant enrolled
January 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
February 10, 2025
February 1, 2025
2.9 years
February 19, 2024
February 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first all-cause readmission within 90 days of discharge
Time to first all-cause readmission within 90 days of discharge.
Day 90
Secondary Outcomes (26)
Time to and frequency of COPD-related readmissions at 30 days
Day 30
Time to and frequency of COPD-related readmissions at 90 days
Day 90
Days alive and out of hospital at day 90
Day 90
Time to and frequency of all COPD exacerbations at day 30
Day 30
Time to and frequency of all COPD exacerbations at day 90
Day 90
- +21 more secondary outcomes
Study Arms (2)
Supported Rescue Pack Arm
EXPERIMENTALAll patients in the SRP arm will receive 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, with patients asked to press the telephone keys 0-9 depending on the answer to the questions. Any patient that has required the use of their rescue pack within 90 days of discharge, will be re-issued with a rescue pack by the central study team and will be sent to the patient home.
No Rescue Pack Arm
NO INTERVENTIONIn this arm, patients will be randomised to receive no rescue packs on discharge. We will very carefully characterise the support provided to people in this arm, upon discharge from hospital, including any access to rescue packs in the community (which we will report, but not modify).
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guy's and St Thomas' NHS Foundation Trustlead
- King's College Londoncollaborator
- University College, Londoncollaborator
- Imperial College Londoncollaborator
- University of Cambridgecollaborator
- University of Southamptoncollaborator
- University of Nottinghamcollaborator
- University of Leicestercollaborator
- Frimley Health NHS Foundation Trustcollaborator
- Newcastle Universitycollaborator
- University of Bristolcollaborator
- Asthma and Lung UKcollaborator
Study Sites (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mona Bafadhel, Professor
King's College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2024
First Posted
April 4, 2024
Study Start
January 30, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
February 10, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share
When the study is complete, a data sharing dataset will be created from the raw data by the study analyst, which will not include any other identifiable data and study PIN will be altered so that individuals are not recognisable from the dataset. The study will comply with the General Data Protection Regulations (GDPR).