Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease

Phase 3RecruitingNCT06347536

Guy's and St Thomas' NHS Foundation Trust1,400 enrolled

Overview

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.

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.

Outcomes

Primary Outcomes

Time to first all-cause readmission within 90 days of discharge

Time to first all-cause readmission within 90 days of discharge.

Time frame: Day 90

Secondary Outcomes

Time to and frequency of COPD-related readmissions at 30 days

Time to and frequency of COPD-related readmissions at 30 days post index discharge.

Time frame: Day 30

Time to and frequency of COPD-related readmissions at 90 days

Time to and frequency of COPD-related readmissions at 90 days post index discharge.

Time frame: Day 90

Days alive and out of hospital at day 90

Days alive and out of hospital at day 90 post index discharge.

Time frame: Day 90

Time to and frequency of all COPD exacerbations at day 30

Time to and frequency of all COPD exacerbations at day 30 post index discharge.

Time frame: Day 30

Time to and frequency of all COPD exacerbations at day 90

Time to and frequency of all COPD exacerbations at day 90 post index discharge.

Time frame: Day 90

Cumulative systemic oral corticosteroids use over 90 days

Cumulative systemic oral corticosteroids use over 90 days post index discharge.

Time frame: Day 90

Cumulative systemic antibiotic use over 90 days

Cumulative systemic antibiotic use over 90 days post index discharge

Time frame: Day 90

Number of health care contacts at baseline, day 90

Number of health care contacts at baseline, day 90 post index discharge

Time frame: Day 90

Number of health care contacts at baseline, day 180

Number of health care contacts at baseline, day 180 post index discharge

Time frame: Day 180

Number of health care contacts at baseline and 1 year

Number of health care contacts at baseline, and 1 year post index discharge

Time frame: Month 12

All cause readmission at 30 days

All cause readmission at 30 days post index discharge

Time frame: 30 days

All cause-, cardiovascular- and COPD- related mortality at day 90

All cause-, cardiovascular- and COPD- related mortality at day 90 post index discharge

Time frame: Day 90

All cause-, cardiovascular- and COPD- related mortality over 12 months

All cause-, cardiovascular- and COPD- related mortality over 12 months post index discharge

Time frame: Month 12

EQ-5D-5L Health questionnaire (quality of life) at 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).

Time frame: Month 12

EQ-5D-5L Health questionnaire (quality of life) at day 90

Time frame: Day 90

EQ-5D-5L Health questionnaire (quality of life) at day 180

Time frame: Day 180

Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at day 90

Time frame: Day 90

Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at day 180

Time frame: Day 180

Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at 1 year

Time frame: Month 12

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.

Time frame: Day 90

Qualitative interview examination of fidelity to and adaptation of the plan in the intervention arm

Time frame: Day 90

Serious adverse events

Time frame: Through study completion, average of 4 years

Presence of bacterial resistance to antimicrobial agents

Proportion of isolates resistant to common antibiotics. This will be assessed via routine microbial laboratory antibiotic sensitivity

Time frame: Through study completion, average of 4 years

Quality of life COPD assessment Test (CAT) score at day 90

Quality of life COPD assessment Test (CAT) score at day 90 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).

Time frame: Day 90

Quality of life COPD assessment Test (CAT) score at day 180

Quality of life COPD assessment Test (CAT) score at day 180 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).

Time frame: Day 180

Quality of life COPD assessment Test (CAT) score at 1 year

Quality of life COPD assessment Test (CAT) score at 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).

Time frame: Month 12

Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease

Overview

Conditions

Interventions

Eligibility

Locations (34)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts