Title: Optimised Inhalers to Reduce COPD Exacerbation Re-Admissions and Mortality - a Feasibility Study
Funder: Department of Health and Social Care

Abstract: We hypothesise that a failure to optimise inhaled drug and drug delivery prior to discharge from hospital after an exacerbation of chronic obstructive pulmonary diseases (COPD) is associated with increased risk of re-admission to hospital and death. This proposal will deliver all the development and feasibility work needed to design a definitive randomised trial to address this hypothesis. This is not an application for the definitive study. Reducing re-admissions and death after COPD exacerbation is an unmet clinical need and research priority for patients and clinicians. Hospitalised COPD exacerbations cause a major burden to patients and to the NHS accounting for >115,000 admissions per year. National COPD Audit (NACAP) data demonstrate that the burden of re-admissions is high: 24% at 30 days, and 43% at 90 days. Moreover, 6% of people discharged will be dead after 30 days, rising to 12% at 90 days. A 10% reduction in admissions would save >&pound;9.25M per year. We hypothesise that optimising use of inhaled medicines prior to discharge will reduce the risk of re-admission and death. This does not happen currently because NICE guidance did not provide practical criteria for use or avoidance of inhaled corticosteroids, and the inhaler technique check recommendation in a standard COPD Discharge Bundle does not recommend use of peak inspiratory flow rate (PIFR) to guide selection of inhaler device, consider patient preference, or provide practical advice on how to detect and correct critical inhaler errors. This results in patients leaving hospital without optimisation of effective exacerbation prevention medicines. We are not currently in a position to proceed to a definitive study &ndash; there are too many remaining uncertainties. First, we need to co-design a tool to guide clinicians how to best choose appropriate inhaled medicines and devices prior to hospital discharge. We will achieve this through a Delphi consensus of clinicians and patients. We then need to test this tool in practice and, in doing so, collect all necessary information in order to design and demonstrate the feasibility of delivering a definitive study to demonstrate that optimising inhaled medicines prior to discharge after COPD exacerbation reduces re-admissions and death. We will achieve this by training two members of staff at each of our three feasibility sites to implement the inhaler selection protocol. Each member of staff will deliver the intervention to fifty patients being treated for COPD exacerbation and eligible for the current Discharge Bundle , giving a sample size of 300. Data collection will be on a tablet-based web-capture e-CRF into RedCap to minimise burden. We will assess implementation using the RE-AIM framework. To obtain breadth and depth in data, we will balance in-depth qualitative data with quantitative measures. We will collect data on 30- and 90-day clinical outcomes (routine in NACAP) to inform the definitive power calculation. We are a team of academic COPD clinicians, qualitative researchers, methodologists and a patient representative working with a Clinical Trials Unit and patient panel. Results of a definitive study would be practice changing and implementable at scale in the NHS.

Lay abstract: INTRODUCTION: Chronic Obstructive Pulmonary Disease (COPD) is a lung condition affecting over three million people in the UK. Exacerbations (flare-ups) of COPD are a common reason for emergency hospital admission. Among people going home from hospital after a COPD exacerbation, more than four-in-ten will be re-admitted within 90 days, and more than one-in-ten will die. We believe that better use of inhaled medicines in people going home from hospital will reduce the risk of re-admission and death. AIM: To reduce re-admissions and death in people following hospital treatment for a COPD exacerbation by better use of inhaled medicines before they go home. BACKGROUND: Inhaled medicines reduce the risk of COPD exacerbations and in 2019 NICE issued new guidelines to help clinicians. Both too little and too much use of medicines called inhaled steroids can be a problem, but NICE did not give practical advice about how to work out which patients will and will not benefit. In addition, patients may inadvertently make mistakes when using inhalers, and some patients don t have strong enough breathing muscles to get the inhaled medicine deep into the lung. Our idea is that a combination of simple, practical advice on inhaler choice, checking that inhalers are being used properly, and ensuring that the breathing muscles are strong enough (with a simple test called In-Check ) can reduce the risk of re-admission and death after exacerbation. DESIGN: There are currently too many unanswered questions to go straight ahead and test our idea. This application is to complete all the necessary work we need to make a decision about whether a full trial is possible, and to design it in the best way. There are two main components to this development work. 1. We will design a simple tool that can be used by health-care staff to decide the best choice of inhalers before a person goes home. We will do this using an approach called a Delphi Consensus which is a good way to arrive at agreement on a topic when there are participants with different views. 2. We will ask six clinicians to test the tool in a total of 300 patients, collecting information about how many changes to inhalers were made, and the views of health-care staff and patients about having their inhalers changed in this way. We will also collect preliminary evidence on whether inhaler changes reduced the risk of re-admission and death. PATIENT AND PUBLIC INVOLVEMENT: The views of patients are central to our work. We have a patient co-applicant affiliated with the British Lung Foundation who will lead patient engagement. Collaboration with patients throughout our work will ensure that their experiences and opinions inform the design of our studies.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: RESPIRATORY