Support for COPD patients after hospital discharge
Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease: An Open-label Multicenter Randomised Controlled Trial
This study tests whether giving COPD patients special rescue packs with medication and a management plan after they leave the hospital can help them stay healthier and avoid going back to the hospital.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1400 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Locations | 34 sites (Barnsley and 33 other locations) |
| Trial ID | NCT06347536 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on providing supported rescue packs to patients with chronic obstructive pulmonary disease (COPD) who have recently been discharged from the hospital after experiencing exacerbations. The rescue packs include a course of prednisolone and antibiotics, along with a basic management plan to help patients manage their condition at home. The study aims to reduce the high rates of readmission and improve self-management during the critical 90-day post-discharge period. By evaluating the effectiveness of these packs, the trial seeks to enhance patient outcomes and reduce healthcare costs associated with COPD exacerbations.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40 and older who have been hospitalized for a COPD exacerbation and are being discharged from secondary care.
Not a fit: Patients requiring invasive ventilation during their hospital admission or those with a life expectancy of less than 90 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce hospital readmissions and improve the quality of life for COPD patients.
How similar studies have performed: Previous studies have indicated that interventions aimed at managing COPD exacerbations post-discharge can lead to improved patient outcomes, suggesting this approach has potential based on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Individuals who require invasive ventilation during the hospital admission * Patients who have an expected survival of less than 90 days * Patients with signs of new consolidation on chest X-ray (if available). * Individuals who have been discharged to a residential or nursing home to residential or nursing home. * Individuals who are unable to manage a supported self-management plan. * Individuals with no access to telephone. * Individuals who are already taking part in an interventional trial. * Previous participation in the RAPID trial.
Where this trial is running
Barnsley and 33 other locations
- Barnsley Hospital NHS Foundation Trust — Barnsley, United Kingdom (Recruiting)
- University Hospitals Birminham NHS Foundation Trust — Birmingham, United Kingdom (Not_yet_recruiting)
- Blackpool Teaching Hospitals — Blackpool, United Kingdom (Not_yet_recruiting)
- Bradford Teaching Hospitals NHS Foundation Trust — Bradford, United Kingdom (Not_yet_recruiting)
- University Hospitals Sussex NHS Foundation Trust — Brighton, United Kingdom (Recruiting)
- North Bristol University Trust — Bristol, United Kingdom (Not_yet_recruiting)
- County Durham and Darlington NHS Foundation Trust — Durham, United Kingdom (Recruiting)
- Gateshead NHS Foundation Trust — Gateshead, United Kingdom (Not_yet_recruiting)
- East Suffolk and North Essex Foundation Trust — Ipswich, United Kingdom (Recruiting)
- University Hospitals of Morecambe Bay NHS Foundation Trust — Lancaster, United Kingdom (Not_yet_recruiting)
- University Hospitals of Leicester NHS Trust — Leicester, United Kingdom (Not_yet_recruiting)
- Cardiff and Vale University Health Board — Llandough, United Kingdom (Not_yet_recruiting)
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (Not_yet_recruiting)
- Imperial College Healthcare NHS Trust — London, United Kingdom (Not_yet_recruiting)
- King's College Hospital — London, United Kingdom (Not_yet_recruiting)
- London North West University Healthcare NHS Trust — London, United Kingdom (Not_yet_recruiting)
- Royal Free London NHS Foundation Trust — London, United Kingdom (Not_yet_recruiting)
- Maidstone and Tunbridge Wells NHS Trust — Maidstone, United Kingdom (Not_yet_recruiting)
- South Tees NHS Foundation Trust — Middlesbrough, United Kingdom (Not_yet_recruiting)
- Milton Keynes University Hospital NHS Foundation Trust — Milton Keynes, United Kingdom (Not_yet_recruiting)
- Newcastle Upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, United Kingdom (Not_yet_recruiting)
- Nottingham University Hospitals Trust — Nottingham, United Kingdom (Recruiting)
- Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (Recruiting)
- Rotherham NHS Foundation Trust — Rotherham, United Kingdom (Recruiting)
- University Hospital Southampton NHS Foundation Trust — Shirley, United Kingdom (Not_yet_recruiting)
- Frimley Health NHS Foundation Trust — Slough, United Kingdom (Not_yet_recruiting)
- South Tyneside and Sunderland NHS Trust — South Shields, United Kingdom (Not_yet_recruiting)
- Southport and Formby District General Hospital — Southport, United Kingdom (Recruiting)
- Stockport NHS Foundation Trust — Stockport, United Kingdom (Recruiting)
- North Tees and Hartlepool NHS Foundation Trust — Stockton-on-Tees, United Kingdom (Recruiting)
- Sherwood Forest Hospitals NHS Foundation Trust — Sutton in Ashfield, United Kingdom (Not_yet_recruiting)
- Somerset Foundation Trust — Taunton, United Kingdom (Not_yet_recruiting)
- Whiston Hospital — Whiston, United Kingdom (Not_yet_recruiting)
- Somerset Foundation Trust — Yeovil, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Mona Bafadhel, Professor — King's College London
- Study coordinator: Mona Bafadhel, Professor
- Email: mona.bafadhel@kcl.ac.uk
- Phone: +44207 848 0606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.