Rescue packs post-discharge in chronic obstructive pulmonary disease (The RAPID study)

Research question: Can rescue packs and a comprehensive self-supported management plan reduce readmissions following exacerbation of COPD?

Background: Chronic obstructive pulmonary disease (COPD) affects approximately 10% of the adult population globally. The disease course is punctuated by exacerbations, which are associated with significant morbidity, healthcare costs and mortality. In the UK, approximately 115,000 exacerbations are severe enough to warrant hospitalisation each year.

National audit data demonstrates that unfortunately, following discharge from hospital, 43% of patients will be readmitted to hospital within 90 days (making this a high-risk period). 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 to use in the event of deterioration.

However, this has not reduced readmissions. Our team has quality improvement data which shows that twice-weekly telephone messaging to patients with COPD following discharge, supporting rescue pack use an reduce readmissions by 30%, with good patient satisfaction. We hypothesise that rescue packs on discharge in addition to a comprehensive self-supported management plan, consisting of the Asthma + Lung UK written management plan (with translations) and twice weekly automated phone messaging during the 90-day high-risk period will reduce readmissions by 20% compared to no rescue packs .

Objectives:

1. Complete a feasibility and pilot study, embedded within the trial to assess recruitment rates, retention rates and primary outcome rates. This will support a go- no go- decision at 18 months.

2. Conduct a multi-centre randomised self-supported management with rescue pack clinical trial across acute hospital trusts in England, Scotland, N. Ireland and Wales

3. Perform a qualitative sub-study to characterise standard care to inform and interpret the data results, by interviewing healthcare practitioners.

4. Perform a qualitative sub-study to understand intervention delivery and the nature of variation to prepare for clinical adoption and interpretation of the results, by interviewing people with COPD who have taken part in the study.

5. Quantify Antimicrobial resistance (AMR) in a sub-study from faecal samples to understand the effects of rescue packs on AMR for wider knowledge synthesis. 6. Quantify the health economic benefits of the findings of the intervention.

Methods: This is a mixed-methods study consisting of a randomised clinical trial, health economics analysis and interview-based qualitative research sub-studies. Primary Outcome: Time to first all-cause readmission within 90 days of discharge.

Intervention: Rescue pack (5 days of 30mg prednisolone to be taken once a day + 5 days of antibiotics) & written Asthma + Lung UK management plan (with translations, for equality and diversity) & twice weekly automated symptom rating telephone calls (or text messaging, for inclusivity) for 90 days. Timelines for delivery: We anticipate this study will take 48 months to complete.

Anticipated impact and dissemination: This nationwide study has been designed by leaders in COPD care across the acute and community pathway an in partnership with patients. If successful results will be readily implementable in clinical practice, translating to better standards of care and improved clinical outcomes and reduced costs to the NHS.