COPDPhase 3RAPIDNCT06347536
Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease
A Phase 3 study testing Supported rescue pack in people with COPD and COPD Exacerbation, run by Guy's and St Thomas' NHS Foundation Trust at 34 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, COPD Exacerbation
- What is being tested?
- Supported rescue pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 34 sitesUnited Kingdom
- Study dates
- 30 Jan 2025to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
34 sites in 1 country
United Kingdom34 sites, 34 recruiting
- Recruiting
Barnsley Hospital NHS Foundation Trust
Barnsley
- Not yet recruiting
University Hospitals Birminham NHS Foundation Trust
Birmingham
- Not yet recruiting
Blackpool Teaching Hospitals
Blackpool
- Not yet recruiting
Bradford Teaching Hospitals NHS Foundation Trust
Bradford
- Recruiting
University Hospitals Sussex NHS Foundation Trust
Brighton
- Not yet recruiting
North Bristol University Trust
Bristol
- Recruiting
County Durham and Darlington NHS Foundation Trust
Durham
- Not yet recruiting
Gateshead NHS Foundation Trust
Gateshead
- Recruiting
East Suffolk and North Essex Foundation Trust
Ipswich
- Not yet recruiting
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster
- Not yet recruiting
University Hospitals of Leicester NHS Trust
Leicester
- Not yet recruiting
Cardiff and Vale University Health Board
Llandough
- Not yet recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Mona Bafadhel, Professor
- Not yet recruiting
Imperial College Healthcare NHS Trust
London
- Not yet recruiting
King's College Hospital
London
- Not yet recruiting
London North West University Healthcare NHS Trust
London
- Not yet recruiting
Royal Free London NHS Foundation Trust
London
John Hurst, Professor
- Not yet recruiting
Maidstone and Tunbridge Wells NHS Trust
Maidstone
- Not yet recruiting
South Tees NHS Foundation Trust
Middlesbrough
- Not yet recruiting
Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes
- Not yet recruiting
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
- Recruiting
Nottingham University Hospitals Trust
Nottingham
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford
- Recruiting
Rotherham NHS Foundation Trust
Rotherham
- Not yet recruiting
University Hospital Southampton NHS Foundation Trust
Shirley
- Not yet recruiting
Frimley Health NHS Foundation Trust
Slough
- Not yet recruiting
South Tyneside and Sunderland NHS Trust
South Shields
- Recruiting
Southport and Formby District General Hospital
Southport
- Recruiting
Stockport NHS Foundation Trust
Stockport
- Recruiting
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees
- Not yet recruiting
Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield
- Not yet recruiting
Somerset Foundation Trust
Taunton
- Not yet recruiting
Whiston Hospital
Whiston
- Not yet recruiting
Somerset Foundation Trust
Yeovil
About this study
Official title: Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease: An Open-label Multicenter Randomised Controlled 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.
Read the detailed description
What is the problem being addressed?
Chronic obstructive pulmonary disease (COPD) is a common lung condition in the United Kingdom, with a prevalence of 4.5% in population ≥40 years and rising4. In addition to daily symptoms such as cough and breathlessness that limit physical activity, people living with COPD are prone to unpredictable deteriorations in their health called 'exacerbations'. Exacerbations are sometimes severe enough to lead to hospital admission and are often driven by infections. A systematic review of patient outcomes in COPD identified exacerbations, especially severe hospitalised exacerbations, as the aspect of COPD that patients found most difficult to live with. Prior to the pandemic there were around 115,000 admissions to hospital with COPD exacerbations per annum6 and admissions are now returning to that level. Exacerbations are more common in the winter with greater circulation of respiratory viruses, and thus the burden of hospitalised exacerbations contributes to winter National Health Service (NHS) bed pressures and cost to the NHS. The annual healthcare cost for people with moderate and severe exacerbation of COPD in England was estimated to be nearly £1 billion in 20227. A particular problem after a hospitalised COPD exacerbation is re-admission to hospital. The National Asthma and COPD Audit Programme (NACAP) has shown that the re-admission rate is 23% at 30 days and 43% at 90 days2. A systematic review conducted by the authors identified comorbidities, previous exacerbations and increased length of stay as risk factors for 30- and 90-day all-cause readmission5.
There are many interventions that can reduce the risk of COPD exacerbations but these are incompletely effective8. There is also evidence to suggest that earlier intervention with standard exacerbation treatment of antibiotics and/or corticosteroids (called a 'rescue pack') can hasten recovery, with a lessened chance of hospital admission9. As part of standard NHS care2, patients with COPD should have a 'discharge bundle' implemented, although this is often poorly delivered and has not been definitively shown to impact outcomes (likely because the wrong outcomes were chosen, and the bundle was poorly implemented)10. The provision of rescue packs is not a standard component of discharge bundles but these are sometimes provided according to local service preference3. Additionally, in usual clinical practice, some patients will have been prescribed rescue packs from primary care (GP) or a community respiratory team (CRT) prior to being hospitalised with COPD. Furthermore, patients may or may not have access to rescue packs from the GP or the CRT after hospital discharge.
Although rescue packs are part of NICE guidance2, the available evidence suggests they are not effective unless provided in the context of a more comprehensive management/education plan that supports patients in their appropriate use11. In practice this usually does not happen3, with evidence that a patient with COPD will receive variable or often no support; with some patients receiving rescue packs on demand without considering antimicrobial resistance, predictable side-effects from steroid overuse, or reviewing appropriateness. The investigators have pilot data that show receiving a rescue pack on hospital discharge is controversial as the hospital team is not, in general, the team that provides ongoing support to use these. There is thus recognised over- and under-use of rescue packs, associated harm from these medicines and variable provision. Providing a rescue pack, with education on how to use and support for when to use, has not been specifically tested in the high-risk 90-day period for readmission following a hospitalised exacerbation. It is the investigators' hypothesis that rescue packs on discharge in addition to a comprehensive self-supported management plan, consisting of the Asthma+Lung UK written management plan and twice weekly automated phone and or text messaging during this 90 day high risk period, will reduce readmissions by 20% compared to standard care.
Why is this research important in terms of improving the health of patients and health and care services?
Reducing re-admission through provision of supported rescue pack use would benefit people living with COPD and the NHS. A reduction in readmissions of 20% could save the NHS £86 million per quarter (£344 million per annum). Conversely, demonstrating that rescue packs are not effective when used in this way will address controversy about use, and reduce pressure on antimicrobial resistance and harm from over-use of oral corticosteroids. Integrated care systems are rapidly developing out-of-hospital support for people with exacerbations of COPD including digitally supported virtual wards. The proposed trial will define the role of supported rescue pack provision in the design and implementation of these programmes, enhancing their ability to reduce demands on urgent and acute care. Whether positive or negative, this trial will help to reduce the current variation in service provision by providing a definitive answer to the study question. Furthermore, preventing exacerbations of COPD have been identified as a priority by the James Lind Alliance (JLA) Priority Setting Partnership (PSP)12.
- Conditions
- COPD, COPD Exacerbation
- Being tested
- Supported rescue pack
- Keywords
- COPD, exacerbation, hospital admission, rescue packs, self-management support
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supported rescue packCombination product
- 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
| Study group | Role | What they receive |
|---|---|---|
| Supported Rescue Pack Arm | Experimental | All 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. Receives: Combination Product: Supported rescue pack |
| No Rescue Pack Arm | No intervention | In 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first all-cause readmission within 90 days of discharge
Time to first all-cause readmission within 90 days of discharge.
Measured: Day 90
Secondary outcomes (26)
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.
Measured: Day 30
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.
Measured: Day 90
Days alive and out of hospital at day 90
Days alive and out of hospital at day 90 post index discharge.
Measured: Day 90
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.
Measured: Day 30
Time to and frequency of all COPD exacerbations at day 90
Time to and frequency of all COPD exacerbations at day 90 post index discharge.
Measured: Day 90
Cumulative systemic oral corticosteroids use over 90 days
Cumulative systemic oral corticosteroids use over 90 days post index discharge.
Measured: Day 90
Cumulative systemic antibiotic use over 90 days
Cumulative systemic antibiotic use over 90 days post index discharge
Measured: Day 90
Number of health care contacts at baseline, day 90
Number of health care contacts at baseline, day 90 post index discharge
Measured: Day 90
Number of health care contacts at baseline, day 180
Number of health care contacts at baseline, day 180 post index discharge
Measured: Day 180
Number of health care contacts at baseline and 1 year
Number of health care contacts at baseline, and 1 year post index discharge
Measured: Month 12
All cause readmission at 30 days
All cause readmission at 30 days post index discharge
Measured: 30 days
All cause-, cardiovascular- and COPD- related mortality at day 90
All cause-, cardiovascular- and COPD- related mortality at day 90 post index discharge
Measured: Day 90
All cause-, cardiovascular- and COPD- related mortality over 12 months
All cause-, cardiovascular- and COPD- related mortality over 12 months post index discharge
Measured: Month 12
EQ-5D-5L Health questionnaire (quality of life) at 1 year
EQ-5D-5L Health Questionnaire score (quality of life) is used to ascertain participants' quality of life as reflected by their capacity for mobility, self care, usual activities, pain or discomfort, anxiety and depression. Mobility self care and usual activities components are graded from "no problems" to "unable to perform" (from best outcome to worst outcome respectively). Pain, anxiety and depression are graded on the scale from "none" to "extreme" (from best outcome to worst outcome respectively).
Measured: Month 12
EQ-5D-5L Health questionnaire (quality of life) at day 90
EQ-5D-5L Health Questionnaire score (quality of life) is used to ascertain participants' quality of life as reflected by their capacity for mobility, self care, usual activities, pain or discomfort, anxiety and depression. Mobility self care and usual activities components are graded from "no problems" to "unable to perform" (from best outcome to worst outcome respectively). Pain, anxiety and depression are graded on the scale from "none" to "extreme" (from best outcome to worst outcome respectively).
Measured: Day 90
EQ-5D-5L Health questionnaire (quality of life) at day 180
EQ-5D-5L Health Questionnaire score (quality of life) is used to ascertain participants' quality of life as reflected by their capacity for mobility, self care, usual activities, pain or discomfort, anxiety and depression. Mobility self care and usual activities components are graded from "no problems" to "unable to perform" (from best outcome to worst outcome respectively). Pain, anxiety and depression are graded on the scale from "none" to "extreme" (from best outcome to worst outcome respectively).
Measured: Day 180
Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at day 90
Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at day 90
Measured: Day 90
Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at day 180
Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at day 180
Measured: Day 180
Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at 1 year
Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at 1 year
Measured: Month 12
Qualitative interviews to examine and describe usual care
Interviews will be conducted by telephone, will take up to approximately 60 minutes, and will be audio-recorded using an encrypted device. They will follow a topic guide focusing on the participant's experience of the post-discharge intervention, including their knowledge of the use of rescue packs, whether they used a rescue pack and in what circumstances, their views on the support and guidance provided (written, telephone, and text message), and the fit of the intervention into their day-to-day lives.
Measured: Day 90
Qualitative interview examination of fidelity to and adaptation of the plan in the intervention arm
Interviews will be conducted by telephone, will take up to approximately 60 minutes, and will be audio-recorded using an encrypted device. They will follow a topic guide focusing on the participant's experience of the post-discharge intervention, including their knowledge of the use of rescue packs, whether they used a rescue pack and in what circumstances, their views on the support and guidance provided (written, telephone, and text message), and the fit of the intervention into their day-to-day lives
Measured: Day 90
Serious adverse events
Serious adverse events
Measured: Through study completion, average of 4 years
Presence of bacterial resistance to antimicrobial agents
Proportion of isolates resistant to common antibiotics. This will be assessed via routine microbial laboratory antibiotic sensitivity
Measured: Through study completion, average of 4 years
Quality of life COPD assessment Test (CAT) score at day 90
Quality of life COPD assessment Test (CAT) score at day 90 post index discharge. The CAT is a validated, short (8-item) and simple patient completed questionnaire, with good discriminant properties, developed for use in routine clinical practice to measure the health status of patients with COPD. The CAT has a scoring range of 0-40, with 0 being the minimal score indicating no disease symptoms (better outcome) and 40 being the maximum indicating the greatest severity of COPD (worse outcome).
Measured: Day 90
Quality of life COPD assessment Test (CAT) score at day 180
Quality of life COPD assessment Test (CAT) score at day 180 post index discharge. The CAT is a validated, short (8-item) and simple patient completed questionnaire, with good discriminant properties, developed for use in routine clinical practice to measure the health status of patients with COPD. The CAT has a scoring range of 0-40, with 0 being the minimal score indicating no disease symptoms (better outcome) and 40 being the maximum indicating the greatest severity of COPD (worse outcome).
Measured: Day 180
Quality of life COPD assessment Test (CAT) score at 1 year
Quality of life COPD assessment Test (CAT) score at 1 year post index discharge. The CAT is a validated, short (8-item) and simple patient completed questionnaire, with good discriminant properties, developed for use in routine clinical practice to measure the health status of patients with COPD. The CAT has a scoring range of 0-40, with 0 being the minimal score indicating no disease symptoms (better outcome) and 40 being the maximum indicating the greatest severity of COPD (worse outcome).
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start30 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, University College, London, Imperial College London, University of Cambridge, University of Southampton, University of Nottingham, University of Leicester, Frimley Health NHS Foundation Trust, Newcastle University, University of Bristol, Asthma and Lung UK
- Responsible party
- Sponsor
- Investigators
- Mona Bafadhel, Professor, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347536
- Sponsor's protocol ID
- IRAS331831
- Other IDs
- NIHR156698
- Acronym
- RAPID
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease: An Open-label Multicenter Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06347536
- Acronym / sponsor ID
- RAPID / IRAS331831
- Conditions
- COPD, COPD Exacerbation
- Keywords
- COPD, exacerbation, hospital admission, rescue packs, self-management support
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London, University College, London, Imperial College London, University of Cambridge, University of Southampton, University of Nottingham, University of Leicester, Frimley Health NHS Foundation Trust, Newcastle University, University of Bristol, Asthma and Lung UK
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
What is the problem being addressed?
Chronic obstructive pulmonary disease (COPD) is a common lung condition in the United Kingdom, with a prevalence of 4.5% in population ≥40 years and rising4. In addition to daily symptoms such as cough and breathlessness that limit physical activity, people living with COPD are prone to unpredictable deteriorations in their health called 'exacerbations'. Exacerbations are sometimes severe enough to lead to hospital admission and are often driven by infections. A systematic review of patient outcomes in COPD identified exacerbations, especially severe hospitalised exacerbations, as the aspect of COPD that patients found most difficult to live with. Prior to the pandemic there were around 115,000 admissions to hospital with COPD exacerbations per annum6 and admissions are now returning to that level. Exacerbations are more common in the winter with greater circulation of respiratory viruses, and thus the burden of hospitalised exacerbations contributes to winter National Health Service (NHS) bed pressures and cost to the NHS. The annual healthcare cost for people with moderate and severe exacerbation of COPD in England was estimated to be nearly £1 billion in 20227. A particular problem after a hospitalised COPD exacerbation is re-admission to hospital. The National Asthma and COPD Audit Programme (NACAP) has shown that the re-admission rate is 23% at 30 days and 43% at 90 days2. A systematic review conducted by the authors identified comorbidities, previous exacerbations and increased length of stay as risk factors for 30- and 90-day all-cause readmission5.
There are many interventions that can reduce the risk of COPD exacerbations but these are incompletely effective8. There is also evidence to suggest that earlier intervention with standard exacerbation treatment of antibiotics and/or corticosteroids (called a 'rescue pack') can hasten recovery, with a lessened chance of hospital admission9. As part of standard NHS care2, patients with COPD should have a 'discharge bundle' implemented, although this is often poorly delivered and has not been definitively shown to impact outcomes (likely because the wrong outcomes were chosen, and the bundle was poorly implemented)10. The provision of rescue packs is not a standard component of discharge bundles but these are sometimes provided according to local service preference3. Additionally, in usual clinical practice, some patients will have been prescribed rescue packs from primary care (GP) or a community respiratory team (CRT) prior to being hospitalised with COPD. Furthermore, patients may or may not have access to rescue packs from the GP or the CRT after hospital discharge.
Although rescue packs are part of NICE guidance2, the available evidence suggests they are not effective unless provided in the context of a more comprehensive management/education plan that supports patients in their appropriate use11. In practice this usually does not happen3, with evidence that a patient with COPD will receive variable or often no support; with some patients receiving rescue packs on demand without considering antimicrobial resistance, predictable side-effects from steroid overuse, or reviewing appropriateness. The investigators have pilot data that show receiving a rescue pack on hospital discharge is controversial as the hospital team is not, in general, the team that provides ongoing support to use these. There is thus recognised over- and under-use of rescue packs, associated harm from these medicines and variable provision. Providing a rescue pack, with education on how to use and support for when to use, has not been specifically tested in the high-risk 90-day period for readmission following a hospitalised exacerbation. It is the investigators' hypothesis that rescue packs on discharge in addition to a comprehensive self-supported management plan, consisting of the Asthma+Lung UK written management plan and twice weekly automated phone and or text messaging during this 90 day high risk period, will reduce readmissions by 20% compared to standard care.
Why is this research important in terms of improving the health of patients and health and care services?
Reducing re-admission through provision of supported rescue pack use would benefit people living with COPD and the NHS. A reduction in readmissions of 20% could save the NHS £86 million per quarter (£344 million per annum). Conversely, demonstrating that rescue packs are not effective when used in this way will address controversy about use, and reduce pressure on antimicrobial resistance and harm from over-use of oral corticosteroids. Integrated care systems are rapidly developing out-of-hospital support for people with exacerbations of COPD including digitally supported virtual wards. The proposed trial will define the role of supported rescue pack provision in the design and implementation of these programmes, enhancing their ability to reduce demands on urgent and acute care. Whether positive or negative, this trial will help to reduce the current variation in service provision by providing a definitive answer to the study question. Furthermore, preventing exacerbations of COPD have been identified as a priority by the James Lind Alliance (JLA) Priority Setting Partnership (PSP)12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supported Rescue Pack Arm | Experimental | Combination Product: Supported rescue packAll 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 intervention | –In 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). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supported rescue pack1) 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 | Combination product | Supported Rescue Pack Arm |
Primary outcome
Time to first all-cause readmission within 90 days of discharge
Time frame: Day 90
Time to first all-cause readmission within 90 days of discharge.
26 secondary outcomes
Time to and frequency of COPD-related readmissions at 30 days
Time frame: Day 30
Time to and frequency of COPD-related readmissions at 90 days
Time frame: Day 90
Days alive and out of hospital at day 90
Time frame: Day 90
Time to and frequency of all COPD exacerbations at day 30
Time frame: Day 30
Time to and frequency of all COPD exacerbations at day 90
Time frame: Day 90
Cumulative systemic oral corticosteroids use over 90 days
Time frame: Day 90
Cumulative systemic antibiotic use over 90 days
Time frame: Day 90
Number of health care contacts at baseline, day 90
Time frame: Day 90
Number of health care contacts at baseline, day 180
Time frame: Day 180
Number of health care contacts at baseline and 1 year
Time frame: Month 12
All cause readmission at 30 days
Time frame: 30 days
All cause-, cardiovascular- and COPD- related mortality at day 90
Time frame: Day 90
All cause-, cardiovascular- and COPD- related mortality over 12 months
Time frame: Month 12
EQ-5D-5L Health questionnaire (quality of life) at 1 year
Time frame: Month 12
EQ-5D-5L Health questionnaire (quality of life) at day 90
Time frame: Day 90
EQ-5D-5L Health questionnaire (quality of life) at day 180
Time frame: Day 180
Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at day 90
Time frame: Day 90
Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at day 180
Time frame: Day 180
Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at 1 year
Time frame: Month 12
Qualitative interviews to examine and describe usual care
Time frame: Day 90
Qualitative interview examination of fidelity to and adaptation of the plan in the intervention arm
Time frame: Day 90
Serious adverse events
Time frame: Through study completion, average of 4 years
Presence of bacterial resistance to antimicrobial agents
Time frame: Through study completion, average of 4 years
Quality of life COPD assessment Test (CAT) score at day 90
Time frame: Day 90
Quality of life COPD assessment Test (CAT) score at day 180
Time frame: Day 180
Quality of life COPD assessment Test (CAT) score at 1 year
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mona Bafadhel, Professor principal investigator
King's College London
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Supported rescue pack in people with COPD and COPD Exacerbation, run by Guy's and St Thomas' NHS Foundation Trust at 34 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mona Bafadhel, Professor (+44207 848 0606, mona.bafadhel@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first all-cause readmission within 90 days of discharge (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.