Supported rescue packs (medications and instructions) post-discharge in chronic obstructive pulmonary disease
| ISRCTN | ISRCTN44283921 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44283921 |
| IRAS number | 331831 |
| ClinicalTrials.gov number | NCT06347536 |
| Secondary identifying numbers | IRAS 331831, NIHR156698, CPMS 63008 |
- Submission date
- 22/02/2024
- Registration date
- 04/07/2024
- Last edited
- 07/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English Summary
Background and study aims
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.
We will conduct a multicentre randomised clinical trial of 1400 patients 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.
Who can participate?
Adults aged 40 years and over, to be discharged from hospital with exacerbation of COPD
What does the study involve?
Patients who consent will be randomly assigned to one of two groups, akin to flipping a coin:
1. Intervention Group: Receives a rescue pack and biweekly automated calls for 90 days, monitoring their health. Calls, lasting over 2 minutes, occur from 10am to 6.30pm Monday to Thursday. If unanswered, up to five callbacks will be made, or a message left.
2. Comparison Group: Receives standard care, without a rescue pack, and no automated calls.
Study Schedule:
- Screening: Eligibility confirmed upon discharge, with consent obtained. Basic medical information collected, optionally including nasal samples.
- Baseline (Day 0): Random assignment, routine investigation results collected, and questionnaires on quality of life and COPD impact completed. Optional stool and nasal samples taken.
- Days 30, 90, 180: Participants interviewed regarding healthcare utilization and medication usage. Questionnaires repeated over the phone. Optionally, stool and nasal samples collected.
- One Year/End of Study: Follow-up call to assess healthcare utilization and adverse events.
What are the possible benefits and risks of participating?
Taking part in the study may help participants better manage your COPD through closer monitoring. We also hope that the knowledge gained from the study will improve our understanding of COPD and the provision of rescue packs, which may help to inform future treatment for COPD patients. Specifically, we will generate evidence on whether use of rescue packs with phone support is something that reduces the likelihood of being re-admitted to hospital. We will also understand more about the potential risks of rescue packs, such as the development of antibiotic-resistant bacteria.
Participants may experience side effects from taking the antibiotics and steroids in a rescue pack, if they need to take them. These can include:
Antibiotics: side effects would depend on which antibiotic has been selected, but more common side-effects might include
• Nausea or vomiting
• Bloating and indigestion
• Diarrhoea
• Thrush
• Rash
Steroids: short term use of corticosteroids is not associated with long term risks, however, but short courses can cause:
• Indigestion or heartburn
• Increased appetite
• Difficulty sleeping (insomnia)
• Changes in mood and behaviour, such as feeling irritable or anxious
• An increased risk of infections – especially chickenpox, shingles, and measles
• High blood sugar (hyperglycemia or diabetes).
Where is the study run from?
King's College London (UK)
Guy's and St Thomas' NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 024 to December 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
rapid-rescue@kcl.ac.uk
Contact information
Scientific, Principal Investigator
King’s Centre for Lung Health, King’s College London, London, UK
School of Immunology and Microbial Sciences
5th Floor Tower
Guys Campus
London
SE1 9RT
United Kingdom
 ORCID ID |
0000-0002-9993-2478 |
|---|---|
| Phone | +44 207 848 0606 |
| mona.bafadhel@kcl.ac.uk |
Scientific, Principal Investigator
UCL Respiratory, University College London, 114 Rayne Building
London
WC1E 6JF
United Kingdom
| ORCID ID |
0000-0002-7246-6040 |
|---|---|
| Phone | +44 208 016 8364 |
| j.hurst@ucl.ac.uk |
Public
King’s Clinical Trials Unit
IoPPN, King’s College London
London
SE5 8AF
United Kingdom
| ORCID ID |
0000-0003-1090-839X |
|---|---|
| Phone | +44 20 7848 0532 |
| olena.said@kcl.ac.uk |
Study information
| Study design | Open-label multicenter randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Supported rescue packs post-discharge in chronic obstructive pulmonary disease: An open-label multicenter randomised controlled trial |
| Study acronym | RAPID |
| Study hypothesis | Provision of a rescue pack of antibiotics and corticosteroids, together with written (and translated) education on their use and twice-weekly telephone (or text) based support for when to use rescue packs, can reduce all-cause hospital re-admission in the 90-day high-risk period following discharge from hospital after an exacerbation of COPD. |
| Ethics approval(s) | Approved 03/07/2024, South Central - Oxford B Research Ethics Committee (Health Research Authority, 2 Redman Place Stratford E20 1JQ, Stratford, E20 1JQ, United Kingdom; +44 207 104 8134; oxfordb.rec@hra.nhs.uk), ref: 24/SC/0186 |
| Condition | Chronic obstructive pulmonary disease (COPD) |
| Intervention | Patients allocated to the intervention arm will receive: 1. A rescue pack (prednisolone and antibiotics for 5-7 days). The prescription will conform to local prescribing guidelines for antibiotic and systemic corticosteroids for exacerbations of COPD. 2. A written rescue pack management plan. 3. Twice-weekly automated telephone symptom reminder calls and/or text messages for 90 days. Comparator Intervention: Usual care (to be studied and described) – but no provision of a rescue pack at discharge. The method of randomisation in the trial is stratified randomisation, using blocking within strata defined by Previous exacerbations in the last year and COPD Hospitalisation in the last year. Randomisation implementation: The randomisation sequence will be generated dynamically by the KCTU team via the KCTU web based randomisation system, in accordance with the specification agreed with the CI and Senior Statistician. The Chief Investigator, Senior Statistician and TMG will be blinded to the sequence generation. |
| Intervention type | Mixed |
| Primary outcome measure | Time to first all-cause readmission within 90 days of discharge measured using patient records |
| Secondary outcome measures | Measured using patient records: 1. Time to and frequency of COPD-related readmissions at 30 and 90 days 2. Days alive and out of hospital at day 90 3. Time to and frequency of all COPD exacerbations at days 30 and 90 4. Cumulative systemic oral corticosteroids use over 90 days 5. Cumulative systemic antibiotic use over 90 days 6. Health care contacts at baseline, days 90 and 180, and 1 year 7. All cause readmission at 30 days 8. All cause-, cardiovascular- and COPD- related mortality at day 90 and over 12 months 9. Quality of life (COPD assessment Test (CAT) score and EQ-5D-5L) at baseline , days 90 and 180, and 1 year 10. 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 11. Qualitative description of usual care 12. Qualitative examination of fidelity to and adaptation of the plan in the intervention arm 13. Adverse events 14. Antimicrobial resistance |
| Overall study start date | 01/01/2024 |
| Overall study end date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Sex | Both |
| Target number of participants | 1400 |
| Participant inclusion criteria | 1. Adults aged 40 years and over 2. Patient to be discharged from hospital with exacerbation of COPD 3. Able to provide informed consent |
| Participant exclusion criteria | Current participant exclusion criteria as of 07/02/2025: 1. Requirement for invasive ventilation during the hospital admission 2. Patients with signs of new consolidation on chest X-ray (if available) 3. Patients who have an expected survival of less than 90 days 4. Discharge to a residential or nursing home 5. Inability to engage with supported self-management 6. No access to telephone 7. Participation in another intervention study 8. Previous participation in the RAPID trial. Previous participant exclusion criteria as of 28/11/2024 to 07/02/2025: 1. Requirement for invasive ventilation during the hospital admission 2. Patients who have an expected survival of less than 90 days 3. Discharge to a residential or nursing home 4. Inability to engage with supported self-management 5. No access to telephone 6. Participation in another intervention study Previous participant exclusion criteria: 1. Requirement for invasive ventilation during the hospital admission 2. Patients who have an expected survival of less than 90 days 3. Discharge to a residential or nursing home 4. Inability to engage with supported self-management 5. No access to telephone 6. Participation in another intervention study 7. Individuals discharged from hospital to a non-physical virtual ward |
| Recruitment start date | 23/01/2025 |
| Recruitment end date | 31/12/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom
Mansfield Road
Sutton-in-ashfield
NG17 4JL
United Kingdom
St Marys Hospital
South Wharf Road
London
W2 1BL
United Kingdom
Turner Road
Colchester
CO4 5JL
United Kingdom
Burton Road
Kendal
LA9 7RG
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Stockton-on-tees
TS19 8PE
United Kingdom
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Lydeard House
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Poplar Grove
Stockport
SK2 7JE
United Kingdom
Kayll Road
South Shields
SR4 7TP
United Kingdom
CF64 2XX
United Kingdom
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
BS10 5NB
United Kingdom
Frimley
Slough
GU16 7UJ
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Tremona Road
Shirley
SO16 6YD
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Sponsor information
University/education
c/o Professor Bashir Al-Hashimi
Vice President (Research and Innovation)
Strand Building
Strand Campus, Strand
London
WC2R 2LS
England
United Kingdom
| Phone | +44 20 7836 5454 |
|---|---|
| bashir.al-hashimi@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Hospital/treatment centre
16th Floor. Tower Wing
Guy’s & St Thomas’ Foundation NHS Trust
Great Maze Pond
London
SE1 9RT
England
United Kingdom
| Phone | +44 2071887188 |
|---|---|
| R&D@gstt.nhs.uk | |
| Website | https://www.guysandstthomasevents.co.uk/ |
|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/01/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The primary and secondary outcomes will be published in a peer reviewed open-source medical journal within 12 months of the end of trial. Recruiting sites will be informed of the results and will be asked to disseminate the findings to participants. Patient groups will be informed of the results for dissemination among their members. |
| IPD sharing plan | When the study is complete, a data sharing dataset will be created from the raw data by the study analyst, which will not include any other identifiable data and study PIN will be altered so that individuals are not recognisable from the dataset. The datasets generated during and/or analysed during the current study will be available upon request from Mona Bafadhel and John Hurst (mona.bafadhel@kcl.ac.uk; j.hurst@ucl.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 4.0 | 05/11/2024 | 07/02/2025 | No | No |
Additional files
Editorial Notes
07/02/2025: The following changes were made:
1. The exclusion criteria were amended.
2. Protocol file (not peer reviewed) added.
28/01/2025: The recruitment start date was changed from 15/01/2025 to 23/01/2025.
30/12/2024: The recruitment start date was changed from 01/12/2024 to 15/01/2025.
28/11/2024: The following changes were made:
1. The exclusion criteria were amended.
2. The recruitment start date was changed from 01/11/2024 to 01/12/2024.
15/10/2024: The recruitment start date was changed from 01/10/2024 to 01/11/2024.
12/08/2024: The following changes were made to the trial record:
1. The ClinicalTrials.gov number was added.
2. The ethics approval was added.
3. The recruitment start date was changed from 01/09/2024 to 01/10/2024.
23/02/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
