protocolSection identificationModule nctId: NCT06347536, orgStudyIdInfo id: IRAS331831, secondaryIdInfos id: NIHR156698, type: OTHER_GRANT, domain: NIHR HTA, briefTitle: Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease, acronym: RAPID, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Guy's and St Thomas' NHS Foundation Trust, class: OTHER, collaborators name: King's College London, collaborators name: University College, London, collaborators name: Imperial College London, collaborators name: University of Cambridge, collaborators name: University of Southampton, collaborators name: University of Nottingham, collaborators name: University of Leicester, collaborators name: Frimley Health NHS Foundation Trust, collaborators name: Newcastle University, collaborators name: University of Bristol, collaborators name: Asthma and Lung UK, descriptionModule briefSummary: 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., conditionsModule conditions: COPD, conditions: COPD Exacerbation, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1400, type: ESTIMATED, armsInterventionsModule interventions name: Supported rescue pack, outcomesModule primaryOutcomes measure: Time to first all-cause readmission within 90 days of discharge, secondaryOutcomes measure: Time to and frequency of COPD-related readmissions at 30 and 90 days, secondaryOutcomes measure: Days alive and out of hospital at day 90, secondaryOutcomes measure: Time to and frequency of all COPD exacerbations at days 30 and 90, secondaryOutcomes measure: Cumulative systemic oral corticosteroids use over 90 days, secondaryOutcomes measure: Cumulative systemic antibiotic use over 90 days, secondaryOutcomes measure: Health care contacts at baseline, days 90 and 180, and 1 year, secondaryOutcomes measure: All cause readmission at 30 days, secondaryOutcomes measure: All cause-, cardiovascular- and COPD- related mortality at day 90 and over 12 months, secondaryOutcomes measure: EQ-5D-5L Health questionnaire (quality of life) at days 90 and 180, and 1 year, secondaryOutcomes measure: Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at days 90 and 180 and 1 year, secondaryOutcomes measure: Qualitative interviews to examine and describe usual care, secondaryOutcomes measure: Qualitative interview examination of fidelity to and adaptation of the plan in the intervention arm, secondaryOutcomes measure: Serious adverse events, secondaryOutcomes measure: Antimicrobial resistance, secondaryOutcomes measure: Quality of life COPD assessment Test (CAT) score at days 90, 180 and 1 year, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Birminham NHS Foundation Trust, city: Birmingham, country: United Kingdom, geoPoint lat: 52.48142, lon: -1.89983, locations facility: Blackpool Teaching Hospitals, city: Blackpool, country: United Kingdom, geoPoint lat: 53.81667, lon: -3.05, locations facility: Bradford Teaching Hospitals NHS Foundation Trust, city: Bradford, country: United Kingdom, geoPoint lat: 53.79391, lon: -1.75206, locations facility: University Hospitals Sussex NHS Foundation Trust, city: Brighton, country: United Kingdom, geoPoint lat: 50.82838, lon: -0.13947, locations facility: North Bristol University Trust, city: Bristol, country: United Kingdom, geoPoint lat: 51.45523, lon: -2.59665, locations facility: County Durham and Darlington NHS Foundation Trust, city: Durham, country: United Kingdom, geoPoint lat: 54.77676, lon: -1.57566, locations facility: East Suffolk and North Essex Foundation Trust, city: Ipswich, country: United Kingdom, geoPoint lat: 52.05917, lon: 1.15545, locations facility: University Hospitals of Morecambe Bay NHS Foundation Trust, city: Lancaster, country: United Kingdom, geoPoint lat: 54.04649, lon: -2.79988, locations facility: University Hospitals of Leicester NHS Trust, city: Leicester, country: United Kingdom, geoPoint lat: 52.6386, lon: -1.13169, locations facility: Cardiff and Vale University Health Board, city: Llandough, country: United Kingdom, geoPoint lat: 51.44556, lon: -3.44722, locations facility: Guy's and St Thomas' NHS Foundation Trust, city: London, country: United Kingdom, contacts name: Mona Bafadhel, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Imperial College Healthcare NHS Trust, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Free London NHS Foundation Trust, city: London, country: United Kingdom, contacts name: John Hurst, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Maidstone and Tunbridge Wells NHS Trust, city: Maidstone, country: United Kingdom, geoPoint lat: 51.26667, lon: 0.51667, locations facility: South Tees NHS Foundation Trust, city: Middlesbrough, country: United Kingdom, geoPoint lat: 54.57623, lon: -1.23483, locations facility: Milton Keynes University Hospital NHS Foundation Trust, city: Milton Keynes, country: United Kingdom, geoPoint lat: 52.04172, lon: -0.75583, locations facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust, city: Newcastle Upon Tyne, country: United Kingdom, geoPoint lat: 54.97328, lon: -1.61396, locations facility: Northumbria Healthcare NHS Foundation Trust, city: North Shields, country: United Kingdom, geoPoint lat: 55.01646, lon: -1.44925, locations facility: Nottingham University Hospitals Trust, city: Nottingham, country: United Kingdom, geoPoint lat: 52.9536, lon: -1.15047, locations facility: Oxford University Hospitals NHS Foundation Trust, city: Oxford, country: United Kingdom, geoPoint lat: 51.75222, lon: -1.25596, locations facility: Salisbury NHS Foundation Trust, city: Salisbury, country: United Kingdom, geoPoint lat: 51.06931, lon: -1.79569, locations facility: University Hospital Southampton NHS Foundation Trust, city: Shirley, country: United Kingdom, geoPoint lat: 52.41074, lon: -1.81952, locations facility: Frimley Health NHS Foundation Trust, city: Slough, country: United Kingdom, geoPoint lat: 51.50949, lon: -0.59541, locations facility: South Tyneside and Sunderland NHS Trust, city: South Shields, country: United Kingdom, geoPoint lat: 54.99859, lon: -1.4323, locations facility: Stockport NHS Foundation Trust, city: Stockport, country: United Kingdom, geoPoint lat: 53.40979, lon: -2.15761, locations facility: North Tees and Hartlepool NHS Foundation Trust, city: Stockton-on-Tees, country: United Kingdom, geoPoint lat: 54.56848, lon: -1.3187, locations facility: Sherwood Forest Hospitals NHS Foundation Trust, city: Sutton In Ashfield, country: United Kingdom, geoPoint lat: 53.12542, lon: -1.26135, locations facility: Somerset Foundation Trust, city: Taunton, country: United Kingdom, geoPoint lat: 51.01494, lon: -3.10293, locations facility: Somerset Foundation Trust, city: Yeovil, country: United Kingdom, geoPoint lat: 50.94159, lon: -2.63211, hasResults: False