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Looking for participantsPhase3

Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease

Sponsor: Guy's and St Thomas' NHS Foundation Trust

NCT ID: NCT06347536

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Supported rescue pack (combination product)
How long the study runs
Study runs about 35 months (dates as stated)
About the drug or intervention
Supported rescue pack — combination product: 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).
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years and over
Who
All
Number of participants
1,400
Started
2025-01-30
Last checked
2025-02

Plain English Summary

What is this study?

  • • Testing a new treatment for copd
  • • Phase3 - 1,400 participants
  • • Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting approximately 10% of the adult population globally

Who can take part?

  • • Ages 40 Years and over
  • • Diagnosed with copd

Where?

  • • Barnsley - Barnsley Hospital NHS Foundation Trust
  • • Birmingham - University Hospitals Birminham NHS Foundation Trust
  • • Blackpool - Blackpool Teaching Hospitals
  • • Bradford - Bradford Teaching Hospitals NHS Foundation Trust
  • • +30 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

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.

COPDCOPD Exacerbation

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Age ≥ 40 years
  • ✓Ability to provide written agreement to take part

Who cannot take part

  • ✗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.
See the full criteria
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 Is This Study? (34 UK sites)

Barnsley Hospital NHS Foundation Trust

Barnsley, United Kingdom

Recruiting
Hospital R&D contact (matched)

RM&G Office

barnsley.research@nhs.net01226 432348

University Hospitals Birminham NHS Foundation Trust

Birmingham, United Kingdom

NOT_YET_RECRUITING

Blackpool Teaching Hospitals

Blackpool, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Dr Angela Parker

bfwh.randd.office@nhs.net01253 (9) 51514 / (9) 55547

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Jane Dennison

bradfordresearch.applications@bthft.nhs.uk01274 382575

University Hospitals Sussex NHS Foundation Trust

Brighton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Scott Harfield

uhsussex.research@nhs.net01273 696955 ext. 67497

North Bristol University Trust

Bristol, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

County Durham and Darlington NHS Foundation Trust

Durham, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development Team cdda-tr.Research@nhs.net

nencadmin@nihr.ac.uk01325 743366

Gateshead NHS Foundation Trust

Gateshead, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Research and Development Team ghnt.researchanddevelopment@nhs.net

ghnt.researchanddevelopment@nhs.net0191 4820000

East Suffolk and North Essex Foundation Trust

Ipswich, United Kingdom

Recruiting
Hospital R&D contact (matched)

Frances Farnworth

R&D@esneft.nhs.uk01473 704787

University Hospitals of Morecambe Bay NHS Foundation Trust

Lancaster, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Nichola Verstraelen

Research.Development@mbht.nhs.uk01524 516484

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Cardiff and Vale University Health Board

Llandough, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Sarah Martin

research.development@wales.nhs.uk029 2074 6986

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Mona Bafadhel, ProfessorPrincipal Investigator

Imperial College Healthcare NHS Trust

London, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

King's College Hospital

London, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

London North West University Healthcare NHS Trust

London, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Sunder Chita

Lnwh-tr.Research@nhs.net020 8869 5829

Royal Free London NHS Foundation Trust

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
John Hurst, ProfessorPrincipal Investigator

Maidstone and Tunbridge Wells NHS Trust

Maidstone, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Denise Day / Julie Knowles

mtw-tr.researchgovernance@nhs.net01622 225627

South Tees NHS Foundation Trust

Middlesbrough, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Research and Development

stees.dtvra@nhs.net01642 854089

Milton Keynes University Hospital NHS Foundation Trust

Milton Keynes, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Antoanela Colda

Antoanela.colda@mkuh.nhs.uk01908 995119 / 01908 996651

Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Research and Development

nuth.genericqueries@nhs.net0191 282 4926

Nottingham University Hospitals Trust

Nottingham, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

Rotherham NHS Foundation Trust

Rotherham, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rachel Walker

rgh-tr.researchanddevelopment@nhs.net01709 426066

University Hospital Southampton NHS Foundation Trust

Shirley, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Frimley Health NHS Foundation Trust

Slough, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Clare Denford

fhft.research-innovation@nhs.net0300 613 2301

South Tyneside and Sunderland NHS Trust

South Shields, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Research and Development stsft.research@nhs.net

stsft.research@nhs.net0191 565 6256 ext 42143

Southport and Formby District General Hospital

Southport, United Kingdom

Recruiting

Stockport NHS Foundation Trust

Stockport, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research, Development & Innovation Office

research.development@stockport.nhs.uk0161 419 5893

North Tees and Hartlepool NHS Foundation Trust

Stockton-on-Tees, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

nth-tr.ntandh.researchdevelopment@nhs.net01642 624090

Sherwood Forest Hospitals NHS Foundation Trust

Sutton in Ashfield, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Alison Steel

sfh-tr.researchandinnovation@nhs.net01623 622515 ext 3990

Somerset Foundation Trust

Taunton, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Karen Tanner

Research@somersetft.nhs.uk01935 384559

Whiston Hospital

Whiston, United Kingdom

NOT_YET_RECRUITING

Somerset Foundation Trust

Yeovil, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Karen Tanner

Research@somersetft.nhs.uk01935 384559

How to Get in Touch

Mona Bafadhel, Professor

Sponsor contact

CONTACT

+44207 848 0606 mona.bafadhel@kcl.ac.uk

Trial Manager

Sponsor contact

CONTACT

+44 20 7848 0532 rapid-rescue@kcl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-02