Structured Review: To Optimise Management and Prevent Harm in COPD

Background: Chronic obstructive pulmonary disease (COPD) is a serious lung condition and the third most common cause of death worldwide. In England, COPD causes 121,129 hospital stays and 20,000 deaths each year. Despite how common and serious it is, only 2% of public research funding targets lung diseases like COPD. People with COPD have sudden and distressing flare-ups (exacerbations). These can be triggered by infections or occur without a clear cause. Exacerbations are serious, they often lead to hospital admission, can cause a lasting health decline, increase the risk of dying and are strongly liked to lower income. Frequent exacerbators is a term used to describe people who experience 2 or more COPD exacerbations each year, and super-exacerbators have 3 or more exacerbations each year. COPD flare-ups are treated with steroid tablets (prednisolone) and sometimes antibiotics. Steroid tablets help recovery but frequent use causes side effects such as weight gain, bone thinning (osteoporosis) and diabetes. People with COPD receive steroids very frequently; a third of all UK steroid prescriptions are for people with COPD, and this number is increasing. Sometimes, people are wrongly diagnosed with COPD, when they have a different health issue. Other diseases (like heart conditions) are common in people with COPD, and share similar symptoms. These have often not been diagnosed and worsening of these conditions can look like a flare-up of COPD, leading to incorrect treatment. Additionally, many people with COPD have not been offered appropriate treatments that would reduce their flare-up frequency. Treatable traits are health-related factors (linked to the lungs, the body and lifestyle choices) that, when identified and managed, can help improve a person's health. Unfortunately many people who are at risk of frequent COPD flare ups are not getting the care they need. According to a 2024 survey by Asthma and Lung UK only 9% of people with COPD are receiving all the key parts of recommended care. The primary aim of the study is to find out if a thorough health assessment, focused on improving participants COPD treatment and identifying other health problems (treatable traits, conditions caused by prednisolone and other common health conditions) will reduce the number of COPD flare-ups individuals have over the next year. STOPmyCOPD focuses on a group of people who have very frequent COPD exacerbations. They are often from disadvantaged backgrounds, rely heavily on healthcare services, and experience worse health outcomes. There is a need to improve diagnoses and treatment in these patients. What is STOPmyCOPD: STOPmyCOPD is a research study looking at people with COPD, who take prednisolone (steroids) for flare-ups of their condition, three of more times a year. The investigators want to see if a thorough assessment (that focuses on the treatment of COPD and diagnosis of other common health conditions), reduces the number of flare-ups that need prednisolone over the next year. Secondary research questions: 1. How many people in the study have COPD and categorise participants by severity, the cause of their COPD, and key characteristics. 2. How many people start new treatments or have changes to their COPD treatment. 3. How many people are found to have a new health condition, and how many start or change treatment for the new health condition. 4. Find out how much steroid (prednisolone) people have taken in the last year and in the previous years. Who has been involved: STOPmyCOPD has been designed for patients and the wider NHS. It supports the goals of the North East and North Cumbria Integrate Care Board and directly addresses the top research priorities of the James Lind Alliance for managing COPD flare-ups (exacerbations). 1. Preventing exacerbations 2. Understanding how other health problems affect COPD exacerbations. 3. Looking at the pros and cons of 'rescue packs' (emergency medication packs containing prednisolone for people with COPD). Seven people with confirmed COPD and a strong interest in research reviewed the study. They looked at how relevant it was, how practical it was and what challenges might occur. They felt STOPmyCOPD tackled an important issue and found the study design clear. Importantly they felt the number of clinic visits and tests were reasonable. One person raised a concern about travel time, so the assessment was amended to a half-day visit, reducing travel burden. The Northumbria Lung Research Patient Advisory Group (PAG), a group of people with COPD also gave feedback. They felt a study of this type was urgently needed. They highlighted that the number of research trials for people with COPD is limited and that COPD research is underfunded. The PAG highlighted the importance of using easy to understand language in documents for patients. The group recommended having regular meetings every six months to stay involved in the study, and this has been built into the design. The study design was developed with the help of Dr Nan Lin (Senior Lecturer in Biostatistics , Population Health Sciences Institute, Newcastle University). He is an expert in this type of research. It has additionally been reviewed by two independent experts in COPD and a Teaching and Research Fellowship committee reviewed the project as part of a Teaching and Research Fellowship. The study was reviewed by AstraZeneca as part of their externally sponsored scientific research (ESR). This underwent review by the Global Reviewing Committee and was endorsed to be scientifically and strategically valid. Consistent and extremely positive feedback was received from all reviewers. The the host organisation has reviewed and fully endorsed the project. Design: The study uses a design where each person is compared to themselves over time (stepped wedge cluster randomisation study). This means the investigators will look at how often each participant had COPD flare-ups before and an intervention, rather than comparing them to other people. Adjustments for external factors (such as the prevalence of flu in the community at the time) will be made to ensure these factors do not affect the results. The study requires 96 participants, with recruitment scheduled over 24 months. This value includes a margin of error in case some people leave the study early. Recruitment: Adults aged 35 and over, who have COPD and have taken three or more courses of prednisolone (in the past 12-months) to treat COPD flare-ups will be invited to patricipate. At the time of entering the study participants must not have had a flare up in the last four weeks. People will not be able to take part if they take steroids tablets (prednisolone) every day for another health condition, have had a lung transplant, use a type of breathing support called NIV (non-invasive ventilation), are housebound or have a serious illness that means they spend most time at home or are unlikely to live beyond 12 months. Participants will be identified through a number of different channels across the North East and North Cumbria Region: * GP's will send out invitation letters and text messages. * Patients admitted to the Northumbria Emergency Care Hospital with a COPD flare up will be invited. * Pharmacists and/or nurses in General Practices will tell patients about the study during medication reviews. * People who have already shown interest in research through registering on the 'Be Part of Research' platform will be invited to join. * Digital adverts displayed in hospital waiting areas/ GP practices and on social media. * VONNE (a network of voluntary organisations in the North East) will help by sharing information about the study with local groups. The Health and Race Equality Forum (HAREF) will support by including study information in their newsletter. * A study website hosted by Northumbria NHS Foundation Trust will contain study details and contact information for the research team. A member of the research team will contact eligible participants by telephone, letter or in person, once they have confirmed they are willing to be contacted. They will provide a patient information sheet, which participants can read themselves or have read aloud to them. Ample time will be given to review the information, ask questions and consider participation. Any questions will be answered by a trained member of the research team. Participants will be reimbursed for travel and will also receive a £100 voucher at the end of the study as a thankyou. Method: The study involves a hospital visit, a follow up appointment, and four telephone calls. The first appointment is a hospital visit in which participants undergo the detailed health check. Following this there is one review appointment followed by four short telephone calls over the next year. Before the Health Assessment Before the health assessment basic information from participants electronic health record will be collected. This will include demographics, past medical conditions and current medications. The Detailed Health Assessment The hospital visit will take around half a day. During this visit the study team will: 1. Confirm (or exclude) the diagnosis of COPD. 2. Make sure participants are on the right COPD treatment for them. 3. Look for other health issues that may be caused by prednisolone use, contribute to symptoms or increase flare-up frequency. 4. Look for common health conditions that have not yet been diagnosed. d) Support behaviour changes that can improve lung health. e) Provide targeted education. Participants will be seen by a doctor and asked to complete questionnaires about their health and quality of life. They will undergo the following investigations: * Sputum sample * Weight and height and waist circumference * Blood pressure * Oxygen levels * Blood tests * Breathing tests * A scan (CT) of the lungs/chest * Heart tests (an ECG and an echocardiogram) Depending on these test results some participants may require further investigations These could include a more detailed scan of the heart (CT coronary angiogram), a bone scan (DEXA), a sleep study and additional blood tests (arterial blood gas). These tests will not be required in all participants and may be arranged to happen at a later date. At the end of the assessment the study team will make sure participants are receiving the correct treatment for their COPD. If any new health conditions (comorbidities) are found, treatment (for example new medication) will be started and optimisation by the study team/or GP. Any treatment offered will follow national NHS guidance and be part of standard care. Participants GP will be kept fully informed of any new diagnoses or treatments. Follow Up: Eight weeks after the health assessment the study team will contact participants to discuss their results and any new diagnoses. The team will review whether any new treatments have been started and whether medication is being taken as prescribed. Participants will then be followed up every 3 months for 12 months with short telephone assessments. During these encounters participants will complete questionnaires about their health and wellbeing. The study team will also collect information about them from their electronic health record, such as the number of emergency hospital visits, serious heart-related events, prednisolone courses taken for COPD flare-ups and deaths. Timeline: Recruitment is scheduled for March 2026, with results expected in 2029. There is a planned 24-month recruitment period, allowed the last participant 12 months to complete follow-up. Sharing results: This study targets a group of people who face significant health challenges and often have poor health outcomes. At the end of the study results will be shared with the public, study participants, healthcare workers, commissioners and guideline advisory groups. The findings will be shared on online platforms, present them at national/international conferences, and published in medical journals. To ensure results reach policymakers, the investigators will also engage with the British Thoracic Society COPD Specialist Advisory Group, NICE, and Asthma and Lung UK. The aim is to ensure findings improve clinical practice, policies and guidelines.