Sputum colour charts to guide antibiotic self-treatment of acute exacerbation of COPD
| ISRCTN | ISRCTN14955629 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14955629 |
| IRAS number | 263204 |
| ClinicalTrials.gov number | NCT04705233 |
| Secondary identifying numbers | CPMS 42074, IRAS 263204 |
- Submission date
- 10/11/2020
- Registration date
- 11/11/2020
- Last edited
- 12/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Chronic obstructive pulmonary disease (COPD) is a long-term condition affecting 2 million people in the UK, causing over 140,000 hospital admissions and 1.7% of UK hospital bed days per year. Common day-to-day symptoms include breathlessness, which is typically worse on exertion, and a cough that produces sputum (phlegm or mucus). One approach to reduce the impact of exacerbations (worsening of COPD symptoms) is the use of self-management (SM) plans, alongside a pack of antibiotics and steroids. The main aim of this study is to assess the effectiveness of using sputum colour charts alongside a self-management SM plan to guide antibiotic self-treatment by patients with acute exacerbations of COPD (AECOPD).
Who can participate?
Patients aged 18 and over with COPD who have had two or more AECOPDs in the previous 12 months OR one or more hospital admissions related to COPD.
What does the study involve?
Participants may be given a sputum colour chart in addition to the usual standard advice. This is a card with different colours on it that covers the range of colours of sputum that they may produce. The researchers are assessing whether the use of this colour chart will help patients manage their symptoms safely and more effectively than just having the standard advice. Participants will be randomly allocated to either have the self-management plan alone or the self-management plan with the sputum colour chart. All patients who take part in the study (regardless of group allocation) will receive two appointments: one at the start and one at the end of the study (12 months). These appointments will be similar to the annual COPD review and will be with the nurse providing the patient's usual care. Appointments will take place over the telephone, via a video link or face-to-face at their GP practice. Patients will also receive telephone calls at 2 weeks and at 3, 6 and 9 months after they enrol on the study. During these calls they will be asked questions regarding their symptoms so that the researchers can record details of any COPD exacerbations which they may have had since agreeing to participate in the study. The questionnaires have been carefully designed with the help of patients and the public to cause as little burden as possible whilst still collecting the information the study needs, but they are in addition to usual care.
What are the possible benefits and risks of participating?
This study will help us to find out which level of support is better at helping patients manage their symptoms. There may be no immediate benefits to taking part, but the aim in the longer term will be to improve care for patients with COPD. The researchers do not know if having extra information will help patients better manage their illness or not. They hope to find this out by doing this study. They could find that having more information makes patients less sure about how to manage their illness, but patients will be closely monitored by the research team throughout the study and any queries and concerns will be dealt with as they arise.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
December 2019 to March 2024
Who is funding the study?
National Institute of Health Research, Health Technology Assessment (NIHR HTA) (UK)
Who is the main contact?
colourcopd@trials.bham.ac.uk
Contact information
Public
COLOUR COPD Senior Data Manager
Birmingham Clinical Trials Unit (BCTU)
Public Health Building
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 415 8444 |
|---|---|
| colourcopd@trials.bham.ac.uk |
Scientific
Institute of Applied Health Research
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0002-5947-3254 |
|---|---|
| Phone | +44 (0)121 3713885 |
| a.m.turner@bham.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Treatment, Education or Self-Management, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Will be available on the study website (not yet active) |
| Scientific title | A two-arm, multi-centre, open-label, parallel-group randomized designed trial investigating the use of sputum colour charts to guide antibiotic self-treatment of acute exacerbation of COPD in patients with COPD (Colour COPD) |
| Study acronym | Colour COPD |
| Study hypothesis | This study is a pragmatic, individually randomized trial, set in primary care, comparing usual care to the use of a sputum colour chart in patients at risk of hospital admission for AECOPD, with the hypothesis that use of a colour chart will be non-inferior to usual care with respect to hospital admission rate after 12 months of follow-up, this being the primary outcome measure. |
| Ethics approval(s) | Approved 09/11/2020, Yorkshire & The Humber - South Yorkshire Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 1048091; southyorks.rec@hra.nhs.uk), REC ref: 20/YH/0273 |
| Condition | Chronic obstructive pulmonary disease |
| Intervention | With the support of the Clinical Research Network, potential participants will be identified by pre-screening of GP records and patients will be sent a Patient Information Sheet (PIS) by post to give further information about the trial. Once adequate time has been allowed to consider the study, a screening appointment (appointment 1) will be undertaken by a Healthcare professional (a Nurse/Research nurse). For Appointment 1 (screening) and Appointment 2 (12-month follow up) one of the following four delivery methods will be used (in order of preference, and to cover all eventualities): 1. Face to face 2. Video consultation 3. Telephone with video links sent via email to all parties to assist with the delivery of the intervention i.e. instructions on how to use the SM Plan +/- sputum colour chart 4. Telephone only (with written instructions posted to intervention participants) Appointment 1: The study will be explained and informed consent will be taken prior to any study assessments being conducted. This initial appointment will be similar to the normal annual COPD review and therefore aligns well with usual care. After the patient has been assessed against the inclusion/exclusion criteria the following activities will take place: 1. Patient demographics and education level recorded 2. A review of medical history and concomitant medication 3. Smoking status confirmed 4. Quality of life questionnaires (CAT and EQ-5D-5L) completed (the nurse to ask the patient the questions and record their answers) 5. MRC score (perceived breathlessness scale) to be determined and recorded 5. Randomisation (via a computerised system) to either the intervention or usual care arm of the study. 6. Record lung function measurements from existing medical history 7. Assess whether the patient has chronic bronchitis Telephone calls: A telephone call will be made by the central research team to the patient 2 weeks after appointment 1 to assess intervention fidelity and provide technical support for e-diary app users (where applicable). Telephone calls will also be made 3 months, 6 months and 9 months after Appointment 1. At each timepoint the patient will be asked if they are happy to reconfirm consent to continue with the study and information regarding any acute exacerbations of COPD since their last study contact will be recorded. Adverse events (defined as any untoward medical occurrence) will also be recorded. The CAT and EQ-5D-5L questionnaires will be completed by reading the questions to the patient and recording their responses. Appointment 2 This will take place 12 months after enrolment (12 months post-randomisation) and as with Appointment 1, it will be similar to the normal annual COPD review. Following reconfirming consent, CAT and EQ-5D-5L questionnaires will be completed. Smoking status and concomitant medication will be recorded, together with MRC score and lung function measurements FEV1 and FVC. Information regarding any acute exacerbations of COPD since last study contact will be collected and recorded. Adverse events will also be recorded. Data will also be collected from the existing GP record. Outcomes such as hospitalisations and mortality will be collected from HES as well as the existing medical record with the merged data being taken to represent the total number of medically confirmed exacerbations. Self-reported AECOPD will be compared to that confirmed in the medical record, however, the medically confirmed value will be assumed as the true number for the purpose of our secondary outcome analysis of AECOPD rate and subsequent economic evaluation. A specific Case Report Form (CRF) will be used to collect all study data and outcomes. E-diary sub-study: Patients will be approached about this sub-study at Appointment 1 and if eligible and consent is obtained they will be given access to the e-diary via an app on their mobile device or tablet. A demonstration of the app will be given using instruction materials provided by the e-diary provider. A written copy of these materials will also be given to patients to take away. Where appointments take place remotely (over the telephone or video link) participants will be talked through how to set up and use the app and written instructions will be sent to them via email or post. They will be asked to complete the e-diary on a daily basis and will receive a telephone call from the central research team 2 weeks after enrolment into the study during the 2-week phone call and they will be encouraged to use the diary if they are not actively doing so by that point and technical support will be provided if required. Site staff will be alerted if the completion drops below 50% of days in any given month and the patient will be contacted to check the reason for non-completion and address any issues. Sputum sub-study: Those patients who have chronic bronchitis will be approached at Appointment 1 for the sputum sub-study. If they consent to this they will be provided with five sputum pots and materials to post the samples to the lab, together with an instruction leaflet detailing how and when to send samples. Samples will be requested at the start and end of the study, and also at all AECOPD, with sputum pots being replenished via their usual care provider as required. Sputum samples will be processed centrally at the lab at the University of Birmingham, and data transferred securely to the trials unit regularly, or immediately if a pathogen is present and may require clinical action. The research team will contact patients with any positive or negative results by their chosen communication method (e.g. telephone or email). The patient's GP will also be informed of any positive sputum infection results. Data will be collected on sputum colour as determined by the laboratory staff against the Bronkotest® chart, pathogens present, and the number of colony-forming units/ml of each potential pathogen seen, as well as any antibiotic resistance seen on routine sensitivity testing. Qualitative sub-study: Some patients and healthcare staff (nurses and doctors) will be approached about participating in research interviews to explore their experiences of living with COPD/managing patients with COPD. These interviews will also ask patients and healthcare staff about their experiences of participating in the main COPD Trial and use of the colour sputum colour charts. |
| Intervention type | Other |
| Primary outcome measure | A binary outcome assessing the incidence of at least one AECOPD over 12 months post randomisation where patients needed hospitalisation (defined by hospital discharge letter/coding). Data will be obtained from NHS digital medical records (hospital episode statistics; HES) which ensures any admissions not reported to the GP are picked up. |
| Secondary outcome measures | Current secondary outcome measures as of 16/02/2021: 1. Number of self-reported AECOPD every 3 months. Time Frame: 3, 6, 9 and 12 months post randomisation 2. Number of self-reported antibiotic and steroid prescriptions for AECOPD. Time Frame: 3, 6, 9 and 12 months post randomisation 3. Number of all cause hospital admissions. Time Frame: 12 months post randomisation taken from Hospital Episode Statistics (HES) and/or participant self-report 4. Number of readmissions to hospital for AECOPD at 30 and 90 days. Time Frame: 12 months post randomisation taken from HES and/or participant self-report 5. Number of Bed days due to AECOPD. Time Frame: 12 months post randomisation taken from HES and/or participant self-report 6. Number of participant deaths from all causes. Time Frame: 12 months post randomisation. All-cause mortality taken from HES and/or medical records 7. Number of unscheduled GP visits for AECOPD. Time Frame: 12 months post randomisation 8. Number of prescriptions for 2nd courses of antibiotics within 14 days of self-reported event (defined as treatment failure). Time Frame: 12 months post randomisation 9. Number of prescriptions for oral anti-fungals. Time Frame: 12 months post randomisation 10. Quality of life by COPD assessment test. Time Frame: 3, 6, 9 and 12 months post randomisation 11. Quality of life measured using the COPD assessment test (CAT) at 3 monthly intervals 12. Quality of life measured using the EuroQoL-5Dimension-5Level (EQ-5D-5L) questionnaire. Time Frame: 3, 6, 9 and 12 months post randomisation 13. Antibiotic resistance. Time Frame: at baseline, all AECOPD and 12 months post randomisation 14. Healthcare resource utilisation. Time Frame: 3, 6 and 9 and 12 months post randomisation. Determined from participant self-report on bespoke questionnaire _____ Previous secondary outcome measures: 1. Self-reported AECOPD (including those for which admission is required) obtained by telephone calls to patients at 3, 6 and 9 months 2. GP-confirmed antibiotic and steroid prescriptions for AECOPD at 12 months 3. All-cause hospital admission taken from HES and/or medical records and measured at 12 months 4. Readmissions to hospital for AECOPD at 30 and 90 days taken from HES and/or medical records at 12 months 5. Bed days due to AECOPD taken from HES and/or medical records at 12 months 6. All-cause mortality taken from HES and/or medical records at 12 months 7. Unscheduled GP visits for AECOPD taken from medical records at 12 months 8. Prescriptions for 2nd courses of antibiotics within 14 days of self-reported event taken from medical records at 12 months 9. Prescriptions for oral anti-fungals taken from medical records at 12 months 10. Quality of life measured using COPD assessment test (CAT) and EQ-5D-5L at 3, 6 and 9 months 11. Antibiotic resistance measured by sputum culture at baseline, all AECOPD and 12 months 12. Healthcare resource utilisation determined from healthcare records at 12 months and patient at 3, 6 and 9 months |
| Overall study start date | 01/12/2019 |
| Overall study end date | 30/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 2954; UK Sample Size: 2954 |
| Total final enrolment | 115 |
| Participant inclusion criteria | 1. Clinically diagnosed COPD, confirmed by a medical record of post-bronchodilator spirometry denoting obstruction 2. ≥2 AECOPD in the 12 months prior to screening according to the patient OR ≥1 hospital admission for AECOPD (i.e., GOLD C or D) |
| Participant exclusion criteria | Household member already participating in the study |
| Recruitment start date | 30/11/2020 |
| Recruitment end date | 30/03/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Vincent Drive
Birmingham
B15 2SQ
United Kingdom
Nelson Street
Manchester
M13 9NQ
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Sale
M33 7SS
United Kingdom
Quarry Bank
Brierley Hill
DY5 2AE
United Kingdom
Didsbury
Manchester
M20 2RN
United Kingdom
Fallowfield
Manchester
M14 6WP
United Kingdom
Huthwaite
Sutton-in-ashfield
NG17 2NF
United Kingdom
Ranson Road
Chilwell
Nottingham
NG9 6DX
United Kingdom
Insall Road, Padgate
Warrington
WA2 0HD
United Kingdom
Hugglescote
Coalville
LE67 2BS
United Kingdom
Cabourne Avenue
Lincoln
LN2 2JP
United Kingdom
Swinton
Manchester
M27 0EW
United Kingdom
Wellington Road
Bollington
Macclesfield
SK10 5JH
United Kingdom
Penrith
CA11 7QN
United Kingdom
Quarry Bank
Brierley Hill
DY5 2AE
United Kingdom
Lancaster
LA1 1RP
United Kingdom
Chesterfield
S40 4AA
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Witney
OX28 6JS
United Kingdom
Woodgate
Birmingham
B32 3SD
United Kingdom
Volunteer Way
Faringdon, Oxfordshire
SN7 7YU
United Kingdom
Bentley Road
Toxteth
Liverpool
L8 0SY
United Kingdom
Wantage
OX12 9BN
United Kingdom
Stechford
Birmingham
B33 8TA
United Kingdom
Sponsor information
University/education
c/o Dr Birgit Whitman
The University of Birmingham
Aston Webb Building, Room 119
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 415 8011 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Documents will be available on the study website (not yet active). Dissemination will occur through conferences and publications, as well as through our PPI group and newsletter. Impact is anticipated through updates to UK COPD guidance around SM plans for AECOPD. The researchers plan to publish the results of the trial in a high-impact peer-reviewed journal. A summary of the results will also be available on the study website (https://www.birmingham.ac.uk/colourcopd). |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from BCTU (bctudatashare@contacts.bham.ac.uk). Data will typically be available within 6 months after the primary publication unless it is not possible to share the data (for example the trial results are to be used as part of a regulatory submission, the release of the data is subject to the approval of a third party who withholds their consent, or BCTU is not the controller of the data). Only scientifically sound proposals from appropriately qualified Research Groups will be considered for data sharing. The request will be reviewed by the BCTU Data Sharing Committee in discussion with the Chief Investigator and, where appropriate (or in absence of the Chief Investigator) any of the following: the Trial Sponsor, the relevant Trial Management Group (TMG), and the independent Trial Steering Committee (TSC). A formal Data Sharing Agreement (DSA) may be required between respective organisations once the release of the data is approved and before data can be released. Data will be fully de-identified (anonymised) unless the DSA covers the transfer of patient identifiable information. Any data transfer will use a secure and encrypted method. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | mixed methods substudy establishing the prevalence of CVD in primary care, | 04/03/2021 | 03/12/2021 | Yes | No |
| Protocol file | version 6.0 | 03/10/2022 | 02/02/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 07/11/2024 | 12/12/2024 | Yes | No |
Additional files
Editorial Notes
12/12/2024: Publication reference added.
15/11/2023: The study participating centres Whitehorse Medical Practice, Brownlow Health, Church Street Practice and Iridium Medical Practice were added.
10/11/2023: The following changes have been made:
1. The public contact was changed.
2. The recruitment end date was changed from 30/11/2023 to 30/03/2023.
3. The overall study end date was changed from 30/11/2024 to 30/03/2024.
4. The intention to publish date was changed from 30/11/2025 to 30/06/2024.
5. The total final enrolment was added.
6. The study participating centres Salford Royal Hospital, Washway Road Medical Centre, Quarry Bank Medical Centre, Barlow Medical Centre, Bodey Medical Centre, Brierley Park Medical Centre, Chilwell Valley and Meadows Practice, Fearnhead Cross Medical Practice, Hugglescote Surgery, Lindum Medical Practice, The Sides Medical Centre, Middlewood Partnership, North Cumbria Integrated Care, Quarry Bank Medical Centre, Queen Square Medical Practice, Royal Primary Care Ashgate, University Hospital Birmingham NHS Trust, Windrush Medical Practice and Woodgate Valley Health Centre were added.
02/02/2023: Protocol uploaded (not peer reviewed).
08/11/2022: The contact email was updated.
30/05/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/11/2022 to 30/11/2023.
2. The overall trial end date has been changed from 30/11/2023 to 30/11/2024 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 30/11/2024 to 30/11/2025.
03/12/2021: Publication reference added.
16/02/2021: The following changes were made to the trial record:
1. The ClinicalTrials.gov number was added.
2. The secondary outcome measures were changed.
11/11/2020: Trial's existence confirmed by the NIHR.
