Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease: An Open-label Multicenter Randomised Controlled Trial

Status: Recruiting
Location: See all (34) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
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. A multicentre randomised clinical trial of 1400 patients will be conducted 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Age ≥ 40 years

• Individuals admitted to hospital with COPD exacerbation who have recently been discharged (discharged from ongoing support from secondary care team which includes hospital and virtual wards). Admission is defined as an episode in which a patient with an exacerbation of COPD is admitted to a ward and has stayed in hospital for 4 hours or more, including Emergency Medicine Centres, Medical Admission Units, Clinical Decision Units, short stay wards or similar but excludes patients treated transiently before being discharged from Emergency Department.

• Ability to provide written informed consent

Locations
Other Locations
United Kingdom
Barnsley Hospital NHS Foundation Trust
RECRUITING
Barnsley
University Hospitals Birminham NHS Foundation Trust
NOT_YET_RECRUITING
Birmingham
Blackpool Teaching Hospitals
NOT_YET_RECRUITING
Blackpool
Bradford Teaching Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Bradford
University Hospitals Sussex NHS Foundation Trust
RECRUITING
Brighton
North Bristol University Trust
NOT_YET_RECRUITING
Bristol
County Durham and Darlington NHS Foundation Trust
RECRUITING
Durham
Gateshead NHS Foundation Trust
NOT_YET_RECRUITING
Gateshead
East Suffolk and North Essex Foundation Trust
RECRUITING
Ipswich
University Hospitals of Morecambe Bay NHS Foundation Trust
NOT_YET_RECRUITING
Lancaster
University Hospitals of Leicester NHS Trust
NOT_YET_RECRUITING
Leicester
Cardiff and Vale University Health Board
NOT_YET_RECRUITING
Llandough
Guy's and St Thomas' NHS Foundation Trust
NOT_YET_RECRUITING
London
Imperial College Healthcare NHS Trust
NOT_YET_RECRUITING
London
King's College Hospital
NOT_YET_RECRUITING
London
London North West University Healthcare NHS Trust
NOT_YET_RECRUITING
London
Royal Free London NHS Foundation Trust
NOT_YET_RECRUITING
London
Maidstone and Tunbridge Wells NHS Trust
NOT_YET_RECRUITING
Maidstone
South Tees NHS Foundation Trust
NOT_YET_RECRUITING
Middlesbrough
Milton Keynes University Hospital NHS Foundation Trust
NOT_YET_RECRUITING
Milton Keynes
Newcastle Upon Tyne Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Newcastle Upon Tyne
Nottingham University Hospitals Trust
RECRUITING
Nottingham
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
Rotherham NHS Foundation Trust
RECRUITING
Rotherham
University Hospital Southampton NHS Foundation Trust
NOT_YET_RECRUITING
Shirley
Frimley Health NHS Foundation Trust
NOT_YET_RECRUITING
Slough
South Tyneside and Sunderland NHS Trust
NOT_YET_RECRUITING
South Shields
Southport and Formby District General Hospital
RECRUITING
Southport
Stockport NHS Foundation Trust
RECRUITING
Stockport
North Tees and Hartlepool NHS Foundation Trust
RECRUITING
Stockton-on-tees
Sherwood Forest Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Sutton In Ashfield
Somerset Foundation Trust
NOT_YET_RECRUITING
Taunton
Whiston Hospital
NOT_YET_RECRUITING
Whiston
Somerset Foundation Trust
NOT_YET_RECRUITING
Yeovil
Contact Information
Primary
Mona Bafadhel, Professor
mona.bafadhel@kcl.ac.uk
+44207 848 0606
Backup
Trial Manager
rapid-rescue@kcl.ac.uk
+44 20 7848 0532
Time Frame
Start Date: 2025-01-30
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 1400
Treatments
Experimental: Supported Rescue Pack Arm
All patients in the SRP arm will receive 1) a rescue pack (prednisolone and antibiotics for 5 days); 2) a written rescue pack management plan based on the Asthma-Lung UK plan; and 3) twice-weekly automated telephone symptom reminder calls for 90 days (with preferred language as needed). The reminder phone calls (to home telephone or mobile) will ask questions aligned to the written management plan, with patients asked to press the telephone keys 0-9 depending on the answer to the questions. Any patient that has required the use of their rescue pack within 90 days of discharge, will be re-issued with a rescue pack by the central study team and will be sent to the patient home.
No_intervention: No Rescue Pack Arm
In this arm, patients will be randomised to receive no rescue packs on discharge. We will very carefully characterise the support provided to people in this arm, upon discharge from hospital, including any access to rescue packs in the community (which we will report, but not modify).
Sponsors
Collaborators: University of Cambridge, Asthma and Lung UK, Newcastle University, University of Leicester, University of Nottingham, Imperial College London, Frimley Health NHS Foundation Trust, University of Bristol, University College, London, King's College London, University of Southampton
Leads: Guy's and St Thomas' NHS Foundation Trust

This content was sourced from clinicaltrials.gov