Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease

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.

Conditions

• COPD
• COPD Exacerbation

Interventions

COMBINATION_PRODUCT

Supported rescue pack

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

Sponsors & Collaborators

• King's College London

  collaborator OTHER

• University College, London

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• University of Cambridge

  collaborator OTHER

• University of Southampton

  collaborator OTHER

• University of Nottingham

  collaborator OTHER

• University of Leicester

  collaborator OTHER

• Frimley Health NHS Foundation Trust

  collaborator UNKNOWN

• Newcastle University

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• Asthma and Lung UK

  collaborator UNKNOWN

• Guy's and St Thomas' NHS Foundation Trust

  lead OTHER

Principal Investigators

• Mona Bafadhel, Professor · King's College London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-30

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• United Kingdom

Study Locations