Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347536
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-02-19
Brief Title:
Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease An Open-label Multicenter Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPID
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 telephonetext 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
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 telephonetext 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 45 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 115000 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 andor 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 implemented10 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 managementeducation 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 AsthmaLung 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 PSP12
Chronic obstructive pulmonary disease COPD is a common lung condition in the United Kingdom with a prevalence of 45 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 115000 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 andor 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 implemented10 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 managementeducation 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 AsthmaLung 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 PSP12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIHR156698 | OTHER_GRANT | NIHR HTA | None |