Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

— RAPID  

Official title:

Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease: An Open-label Multicenter Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06347536
• Other study ID #: IRAS331831
• Secondary ID: NIHR156698
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Mona Bafadhel, Professor
• Phone: +44207 848 0606
• Email: mona.bafadhel[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1400
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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
• 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.

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Combination Product:
• Supported rescue pack
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

Locations

Country	Name	City	State
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	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	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	Northumbria Healthcare NHS Foundation Trust	North Shields
United Kingdom	Nottingham University Hospitals Trust	Nottingham
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	Salisbury NHS Foundation Trust	Salisbury
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	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	Somerset Foundation Trust	Yeovil

Sponsors (12)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	Asthma and Lung UK, Frimley Health NHS Foundation Trust, Imperial College London, King's College London, Newcastle University, University College, London, University of Bristol, University of Cambridge, University of Leicester, University of Nottingham, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to and frequency of COPD-related readmissions at 30 and 90 days	Time to and frequency of COPD-related readmissions at 30 and 90 days post index discharge.	Day 30, Day 90
Secondary	Days alive and out of hospital at day 90	Days alive and out of hospital at day 90 post index discharge.	Day 90
Secondary	Time to and frequency of all COPD exacerbations at days 30 and 90	Time to and frequency of all COPD exacerbations at days 30 and 90 post index discharge.	Day 30, Day 90
Secondary	Cumulative systemic oral corticosteroids use over 90 days	Cumulative systemic oral corticosteroids use over 90 days post index discharge.	Day 90
Secondary	Cumulative systemic antibiotic use over 90 days	Cumulative systemic antibiotic use over 90 days post index discharge	Day 90
Secondary	Health care contacts at baseline, days 90 and 180, and 1 year	Health care contacts at baseline, days 90 and 180, and 1 year post index discharge	Day 90, Day 180, Month 12
Secondary	All cause readmission at 30 days	All cause readmission at 30 days post index discharge	30 days
Secondary	All cause-, cardiovascular- and COPD- related mortality at day 90 and over 12 months	All cause-, cardiovascular- and COPD- related mortality at day 90 and over 12 months post index discharge	Day 90, Month 12
Secondary	EQ-5D-5L Health questionnaire (quality of life) at days 90 and 180, and 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).	Day 90, Day 180, Month 12
Secondary	Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at days 90 and 180 and 1 year	Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at days 90 and 180 and 1 year	Day 90, Day 180, Month 12
Secondary	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.	Day 90
Secondary	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	Day 90
Secondary	Serious adverse events	Serious adverse events	Through study completion, average of 4 years
Secondary	Antimicrobial resistance	Antimicrobial resistance	Through study completion, average of 4 years
Secondary	Quality of life COPD assessment Test (CAT) score at days 90, 180 and 1 year	Quality of life COPD assessment Test (CAT) score at days 90, 180 and 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).	Day 90, day 180, month 12