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Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease

Study acronym: RAPID
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2024 to Jan 30, 2025
    • Study sites: 29 to 34
    • Eligibility criteria expanded, about 9 words
    v4
  2. Notable Start date: May 2024 to Oct 2024
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 15 to 26
    v3
  3. Minor Secondary endpoints revised (15)v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06347536
Lead Sponsor Guy's and St Thomas' NHS Foundation Trust
Collaborators: King's College London, University College, London, Imperial College London, University of Cambridge, University of Southampton, University of Nottingham, University of Leicester, Frimley Health NHS Foundation Trust, Newcastle University, University of Bristol, Asthma and Lung UK
Conditions
(from sponsor)
COPD, COPD Exacerbation
Related terms Pulmonary Disease, Chronic Obstructive
Enrollment 1,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov