Actively Recruiting

Phase 3
Age: 40Years +
All Genders
NCT06347536

Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease

Led by Guy's and St Thomas' NHS Foundation Trust · Updated on 2025-02-10

1400

Participants Needed

34

Research Sites

152 weeks

Total Duration

On this page

Sponsors

G

Guy's and St Thomas' NHS Foundation Trust

Lead Sponsor

K

King's College London

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 40 years or older
  • Recently discharged from hospital after admission for a COPD exacerbation involving at least a 4-hour stay
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Need for invasive ventilation during hospital admission
  • Expected survival less than 90 days
  • Signs of new lung consolidation on chest X-ray (if available)
  • Discharged to a residential or nursing home
  • Unable to manage a supported self-management plan
  • No access to telephone
  • Currently participating in another interventional trial
  • Previous participation in the RAPID trial

AI-Screening

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Trial Site Locations

Total: 34 locations

1

Barnsley Hospital NHS Foundation Trust

Barnsley, United Kingdom

Actively Recruiting

2

University Hospitals Birminham NHS Foundation Trust

Birmingham, United Kingdom

Not Yet Recruiting

3

Blackpool Teaching Hospitals

Blackpool, United Kingdom

Not Yet Recruiting

4

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, United Kingdom

Not Yet Recruiting

5

University Hospitals Sussex NHS Foundation Trust

Brighton, United Kingdom

Actively Recruiting

6

North Bristol University Trust

Bristol, United Kingdom

Not Yet Recruiting

7

County Durham and Darlington NHS Foundation Trust

Durham, United Kingdom

Actively Recruiting

8

Gateshead NHS Foundation Trust

Gateshead, United Kingdom

Not Yet Recruiting

9

East Suffolk and North Essex Foundation Trust

Ipswich, United Kingdom

Actively Recruiting

10

University Hospitals of Morecambe Bay NHS Foundation Trust

Lancaster, United Kingdom

Not Yet Recruiting

11

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Not Yet Recruiting

12

Cardiff and Vale University Health Board

Llandough, United Kingdom

Not Yet Recruiting

13

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Not Yet Recruiting

14

Imperial College Healthcare NHS Trust

London, United Kingdom

Not Yet Recruiting

15

King's College Hospital

London, United Kingdom

Not Yet Recruiting

16

London North West University Healthcare NHS Trust

London, United Kingdom

Not Yet Recruiting

17

Royal Free London NHS Foundation Trust

London, United Kingdom

Not Yet Recruiting

18

Maidstone and Tunbridge Wells NHS Trust

Maidstone, United Kingdom

Not Yet Recruiting

19

South Tees NHS Foundation Trust

Middlesbrough, United Kingdom

Not Yet Recruiting

20

Milton Keynes University Hospital NHS Foundation Trust

Milton Keynes, United Kingdom

Not Yet Recruiting

21

Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Not Yet Recruiting

22

Nottingham University Hospitals Trust

Nottingham, United Kingdom

Actively Recruiting

23

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Actively Recruiting

24

Rotherham NHS Foundation Trust

Rotherham, United Kingdom

Actively Recruiting

25

University Hospital Southampton NHS Foundation Trust

Shirley, United Kingdom

Not Yet Recruiting

26

Frimley Health NHS Foundation Trust

Slough, United Kingdom

Not Yet Recruiting

27

South Tyneside and Sunderland NHS Trust

South Shields, United Kingdom

Not Yet Recruiting

28

Southport and Formby District General Hospital

Southport, United Kingdom

Actively Recruiting

29

Stockport NHS Foundation Trust

Stockport, United Kingdom

Actively Recruiting

30

North Tees and Hartlepool NHS Foundation Trust

Stockton-on-Tees, United Kingdom

Actively Recruiting

31

Sherwood Forest Hospitals NHS Foundation Trust

Sutton in Ashfield, United Kingdom

Not Yet Recruiting

32

Somerset Foundation Trust

Taunton, United Kingdom

Not Yet Recruiting

33

Whiston Hospital

Whiston, United Kingdom

Not Yet Recruiting

34

Somerset Foundation Trust

Yeovil, United Kingdom

Not Yet Recruiting

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Research Team

M

Mona Bafadhel, Professor

CONTACT

T

Trial Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease | DecenTrialz