Supported rescue packs post-discharge in chronic obstructive pulmonary disease: An open-label multicenter randomised controlled trial (RAPID)

Research summary

Sample Size: Due to the sample size of the study,an embedded pilot trial will be performed from months 6 to 18 to assess site recruitment rates,patient retention rates,all trial processes and the number of primary events occurring. It is envisaged that there will be up to 24 sites open,with 363 patients recruited (25% of the total sample size). A go-no go decision at month 18 will be available. Recruitment: This study will recruit patients with COPD from diverse acute NHS trusts. We have reached out to the national respiratory clinical research network (CRN) delivery team who have notified trusts for their expression of interest in taking part. We have had confirmation from principal investigators (PIs) from 20 sites across all of England (London,South-East,South-West,Midlands,North-East,and North-West) and from the devolved nations (Wales,Scotland and Northern Ireland). Furthermore,after discussion with the local CRN delivery team,with patient and public involvement and engagement (PPIE) and with the NIHR Be Part of Research initiative,we will obtain informed consent permission to contact patients about for future COPD research studies. Diversity of patients recruited: For non-English speakers,written patient information will be made available in selected preferred language. Translations will be made available and targeted to the most frequent languages and dialects as per ONS 2021 Census Data. The PPI group will help to create participant-facing trial materials that will be used in the study. This will enable the trial materials to be as acceptable,clear and patient-friendly as possible. COM-B and Burden of Treatment theory will be used to inform interview topic guides. PPI have informed the frequency of questionnaires/tests/intervention/focus groups/interviews. Patients Interviews will be conducted remotely via telephone or videoconference,using an interpreter where the participant’s preferred language is not English. PPIE involvement: Through the James Lind Alliance priority setting partnership with patients we were instrumental in highlighting the research question and the NIHR HTA commissioned call,for which this application was successful for funding and award. Further PPI contribution has developed the proposal,including pilot work of the telephone-based symptom prompts and collating information on the experience and variance in usual care across 11 UK sites including review and a survey of 20 patients admitted with acute exacerbation,with peer consultation of the minimally important difference in treatment effect size. We will continue this embedded PPIE approach in all our study activities. This includes how we run our study and interpreting and reporting our results. Our broad collaboration ensures generalisability across the UK with a focus on areas of highest COPD related burden and health inequality,embedding practices in the NHS. We cover urban,rural and coastal populations and populations from a range of heritages and backgrounds,working with sites that are among the most deprived 20% in England (Index of Multiple Deprivation). Our PPIE and dissemination involvement includes working with Asthma + Lung UK. We have a designated PPI manager,in partnership with Asthma + Lung UK and have considered and costed PPI dissemination and impact. This will focus on how to translate the study findings to lay audiences,in addition to reports and newsletters to the wider respiratory community including over 100,000 patients with chronic lung disease as part of A+LUK dissemination. This is a low participant burden study design which should not result in costs to participants. There are no additional study visits which require compensation or incentive payments. Our model will ensure that patients are involved at a strategic level as members of the Trial Management Group,the Stakeholder Group and at local level. Defining discharge for randomisation: We recognise that across the NHS,there will be different care pathways including virtual wards and hospital at home. Taking this into account,we thus define hospital admission,as per the Royal College of Physicians audit (NACAP),as an episode in which a patient with an exacerbation of COPD exacerbation is admitted to a ward and has stayed in hospital for 4 hours or more (this includes Emergency Medicine Centres,Medical Admission Units,Clinical Decision Units,short stay wards or similar,but excludes patients treated transiently before discharge from the Emergency Department (ED)). We define discharge as discharge from ongoing support from a secondary care team,which may be when the patient physically leaves hospital. Telephone reminder messaging: This builds on technologies already widely used in clinical practice (e.g.,reminder surveys from GP practice) and those used in commercial trials to detect exacerbations of COPD. A responsive predesigned algorithm will inform patients i) the need to consider consulting their written plan; ii) consideration of starting the rescue pack; and iii) any further consultation with their usual COPD care provider (GP,CRT,local pharmacist). Coapplicant data has suggested using this method can reduce re-admissions by 30% in a non-randomised service implementation; in addition to positive PPIE feedback (‘allows patients to recognise symptoms better’ and ‘is a great way to communicate providing me with confidence in managing my COPD’). This technology has also been embedded into EMIS records in primary care for other use (surveys for patients after attending a GP consultation). Ethics: Informed and written consent will be obtained from participants.

Principal Investigator

Dr Rob Hallifax

Contact us

Email: catherine.borg@ouh.nhs.uk

Phone: 01865227242

IRAS number

331831