RAPID
Research type
Research Study
Full title
Supported rescue packs post-discharge in chronic obstructive pulmonary disease: An open-label multicenter randomised controlled trial
IRAS ID
331831
Contact name
Mona Bafadhel
Contact email
Sponsor organisation
King's College London
ISRCTN Number
ISRCTN44283921
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
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.
We will conduct a multicentre randomised clinical trial of 1400 patients 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
REC name
South Central - Oxford B Research Ethics Committee
REC reference
24/SC/0186
Date of REC Opinion
3 Jul 2024
REC opinion
Further Information Favourable Opinion