Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease

Last updated: February 6, 2025
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Supported rescue pack

Clinical Study ID

NCT06347536
IRAS331831
NIHR156698
  • Ages > 40
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 40 years

  • Individuals admitted to hospital with COPD exacerbation who have recently beendischarged (discharged from ongoing support from secondary care team which includeshospital and virtual wards). Admission is defined as an episode in which a patientwith an exacerbation of COPD is admitted to a ward and has stayed in hospital for 4hours or more, including Emergency Medicine Centres, Medical Admission Units,Clinical Decision Units, short stay wards or similar but excludes patients treatedtransiently before being discharged from Emergency Department.

  • Ability to provide written informed consent

Exclusion

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 residentialor 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.

Study Design

Total Participants: 1400
Treatment Group(s): 1
Primary Treatment: Supported rescue pack
Phase: 3
Study Start date:
January 30, 2025
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Barnsley Hospital NHS Foundation Trust

    Barnsley,
    United Kingdom

    Active - Recruiting

  • University Hospitals Birminham NHS Foundation Trust

    Birmingham,
    United Kingdom

    Site Not Available

  • Blackpool Teaching Hospitals

    Blackpool,
    United Kingdom

    Site Not Available

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford,
    United Kingdom

    Site Not Available

  • University Hospitals Sussex NHS Foundation Trust

    Brighton,
    United Kingdom

    Active - Recruiting

  • North Bristol University Trust

    Bristol,
    United Kingdom

    Site Not Available

  • County Durham and Darlington NHS Foundation Trust

    Durham,
    United Kingdom

    Active - Recruiting

  • Gateshead NHS Foundation Trust

    Gateshead,
    United Kingdom

    Site Not Available

  • East Suffolk and North Essex Foundation Trust

    Ipswich,
    United Kingdom

    Active - Recruiting

  • University Hospitals of Morecambe Bay NHS Foundation Trust

    Lancaster,
    United Kingdom

    Site Not Available

  • University Hospitals of Leicester NHS Trust

    Leicester,
    United Kingdom

    Site Not Available

  • Cardiff and Vale University Health Board

    Llandough,
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' NHS Foundation Trust

    London,
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust

    London,
    United Kingdom

    Site Not Available

  • King's College Hospital

    London,
    United Kingdom

    Site Not Available

  • London North West University Healthcare NHS Trust

    London,
    United Kingdom

    Site Not Available

  • Royal Free London NHS Foundation Trust

    London,
    United Kingdom

    Site Not Available

  • Maidstone and Tunbridge Wells NHS Trust

    Maidstone,
    United Kingdom

    Site Not Available

  • South Tees NHS Foundation Trust

    Middlesbrough,
    United Kingdom

    Site Not Available

  • Milton Keynes University Hospital NHS Foundation Trust

    Milton Keynes,
    United Kingdom

    Site Not Available

  • Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle Upon Tyne,
    United Kingdom

    Site Not Available

  • Northumbria Healthcare NHS Foundation Trust

    North Shields,
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals Trust

    Nottingham,
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford,
    United Kingdom

    Active - Recruiting

  • Rotherham NHS Foundation Trust

    Rotherham,
    United Kingdom

    Active - Recruiting

  • Salisbury NHS Foundation Trust

    Salisbury,
    United Kingdom

    Site Not Available

  • University Hospital Southampton NHS Foundation Trust

    Shirley,
    United Kingdom

    Site Not Available

  • Frimley Health NHS Foundation Trust

    Slough,
    United Kingdom

    Site Not Available

  • South Tyneside and Sunderland NHS Trust

    South Shields,
    United Kingdom

    Site Not Available

  • Southport and Formby District General Hospital

    Southport,
    United Kingdom

    Active - Recruiting

  • Stockport NHS Foundation Trust

    Stockport,
    United Kingdom

    Active - Recruiting

  • North Tees and Hartlepool NHS Foundation Trust

    Stockton-on-Tees,
    United Kingdom

    Active - Recruiting

  • Sherwood Forest Hospitals NHS Foundation Trust

    Sutton In Ashfield,
    United Kingdom

    Site Not Available

  • Somerset Foundation Trust

    Taunton,
    United Kingdom

    Site Not Available

  • Whiston Hospital

    Whiston,
    United Kingdom

    Site Not Available

  • Somerset Foundation Trust

    Yeovil,
    United Kingdom

    Site Not Available

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