Clinical trial NCT06347536: Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease
Official title: Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease: An Open-label Multicenter Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: COPD
COPD Exacerbation
Keywords: COPD
exacerbation
hospital admission
rescue packs
self-management support
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
name: University College, London
name: Imperial College London
name: University of Cambridge
name: University of Southampton
name: University of Nottingham
name: University of Leicester
name: Frimley Health NHS Foundation Trust
name: Newcastle University
name: University of Bristol
name: Asthma and Lung UK
First posted: 2024-04-04
Enrollment: 1400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Time to first all-cause readmission within 90 days of discharge
timeFrame: Day 90
Secondary outcomes:
measure: Time to and frequency of COPD-related readmissions at 30 days
timeFrame: Day 30
measure: Time to and frequency of COPD-related readmissions at 90 days
timeFrame: Day 90
measure: Days alive and out of hospital at day 90
timeFrame: Day 90
measure: Time to and frequency of all COPD exacerbations at day 30
timeFrame: Day 30
measure: Time to and frequency of all COPD exacerbations at day 90
timeFrame: Day 90
measure: Cumulative systemic oral corticosteroids use over 90 days
timeFrame: Day 90
measure: Cumulative systemic antibiotic use over 90 days
timeFrame: Day 90
measure: Number of health care contacts at baseline, day 90
timeFrame: Day 90
measure: Number of health care contacts at baseline, day 180
timeFrame: Day 180
measure: Number of health care contacts at baseline and 1 year
timeFrame: Month 12
measure: All cause readmission at 30 days
timeFrame: 30 days
measure: All cause-, cardiovascular- and COPD- related mortality at day 90
timeFrame: Day 90
measure: All cause-, cardiovascular- and COPD- related mortality over 12 months
timeFrame: Month 12
measure: EQ-5D-5L Health questionnaire (quality of life) at 1 year
timeFrame: Month 12
measure: EQ-5D-5L Health questionnaire (quality of life) at day 90
timeFrame: Day 90
measure: EQ-5D-5L Health questionnaire (quality of life) at day 180
timeFrame: Day 180
measure: Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at day 90
timeFrame: Day 90
measure: Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at day 180
timeFrame: Day 180
measure: Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at 1 year
timeFrame: Month 12
measure: Qualitative interviews to examine and describe usual care
timeFrame: Day 90
measure: Qualitative interview examination of fidelity to and adaptation of the plan in the intervention arm
timeFrame: Day 90
measure: Serious adverse events
timeFrame: Through study completion, average of 4 years
measure: Presence of bacterial resistance to antimicrobial agents
timeFrame: Through study completion, average of 4 years
measure: Quality of life COPD assessment Test (CAT) score at day 90
timeFrame: Day 90
measure: Quality of life COPD assessment Test (CAT) score at day 180
timeFrame: Day 180
measure: Quality of life COPD assessment Test (CAT) score at 1 year
timeFrame: Month 12
Other outcomes:
Locations:
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
city: Birmingham
country: United Kingdom
facility: University Hospitals Birminham NHS Foundation Trust
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospitals
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
city: Brighton
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: North Bristol University Trust
city: Durham
country: United Kingdom
facility: County Durham and Darlington NHS Foundation Trust
city: Gateshead
country: United Kingdom
facility: Gateshead NHS Foundation Trust
city: Ipswich
country: United Kingdom
facility: East Suffolk and North Essex Foundation Trust
city: Lancaster
country: United Kingdom
facility: University Hospitals of Morecambe Bay NHS Foundation Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: Llandough
country: United Kingdom
facility: Cardiff and Vale University Health Board
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: London North West University Healthcare NHS Trust
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: Maidstone
country: United Kingdom
facility: Maidstone and Tunbridge Wells NHS Trust
city: Middlesbrough
country: United Kingdom
facility: South Tees NHS Foundation Trust
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University Hospital NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Rotherham
country: United Kingdom
facility: Rotherham NHS Foundation Trust
city: Shirley
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Slough
country: United Kingdom
facility: Frimley Health NHS Foundation Trust
city: South Shields
country: United Kingdom
facility: South Tyneside and Sunderland NHS Trust
city: Southport
country: United Kingdom
facility: Southport and Formby District General Hospital
city: Stockport
country: United Kingdom
facility: Stockport NHS Foundation Trust
city: Stockton-on-Tees
country: United Kingdom
facility: North Tees and Hartlepool NHS Foundation Trust
city: Sutton In Ashfield
country: United Kingdom
facility: Sherwood Forest Hospitals NHS Foundation Trust
city: Taunton
country: United Kingdom
facility: Somerset Foundation Trust
city: Whiston
country: United Kingdom
facility: Whiston Hospital
city: Yeovil
country: United Kingdom
facility: Somerset Foundation Trust
Study officials:
affiliation: King's College London
name: Mona Bafadhel, Professor
role: PRINCIPAL_INVESTIGATOR
References: