Sputum Colour Charts to Guide Antibiotic Self-treatment of Acute Exacerbation of COPD (Colour COPD)

Study Overview
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Brief Summary
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The primary objective of this study is to determine if a sputum colour chart can aid patient self-management of COPD exacerbations, such that use of the chart is non-inferior to usual care with respect to hospital admissions. There are also a range of other secondary objectives as detailed in the secondary outcomes section. An integral pilot phase, economic evaluation and process evaluation are also included.

Detailed Description
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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 Acute Exacerbation of Chronic Obstructive Pulmonary Disease (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. Use of a chart might reduce antibiotic use, and thus might also change patterns of antibiotic resistance long term, such that these are important secondary outcomes. There is an internal pilot phase, a detailed process evaluation and a cost-effectiveness study. The trial protocol also includes three sub-studies: 1) using a daily electronic symptom diary capable of picking up symptom defined (but potentially unreported) AECOPD, since these are an important prognostic marker (section 3); 2) collecting sputum samples from patients to assess patterns of antibiotic resistance and 3) a qualitative study which will include staff (for example, healthcare staff delivering the intervention) and patients. This trial uses a sputum colour chart as part of a self-management intervention that enables patients with COPD to determine whether they have an exacerbation, and whether this requires antibiotic treatment. The 5 point sputum colour chart, adapted from Bronkotest® is being used.

Official Title
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A 2 Arm, Multi-centre, Open Label, Parallel-group Randomised 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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Other: sputum colour chart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically diagnosed COPD, confirmed by a medical record of post-bronchodilator spirometry denoting obstruction. ≥2 AECOPD in the 12 months prior to screening according to the patient or ≥1 hospital admission for AECOPD (i.e. Global Initiative for Chronic Obstructive Lung Disease- GOLD; C or D). Able to safely use SM plan in the view of their usual care practitioner Able to use sputum colour chart; this will be confirmed by a sight test if there is any doubt on initial assessment by the usual care or research team. Patients who report being colour blind will have their ability to use the chart tested at the screening visit. Written Informed consent given Additionally, to participate in the E-diary sub-study. - Access to smartphone/tablet and an email address. Additionally, to participate in the Sputum sub-study. - Chronic bronchitis, defined by self-reported sputum production for at least 3 months in each of 2 consecutive years or more. Exclusion Criteria: Household member already participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A 2 arm, multi-centre, open label, parallel-group randomised designed trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sputum chart<br>Use of the 5 point sputum colour chart, adapted from Bronkotest® a self-management (SM) plan and rescue pack (RP) containing 5 days supply of antibiotic and steroid treatment | Other: sputum colour chart<br>* 5-point Sputum Colour Chart plus best standard care<br>|
| No Intervention: Control<br>Use of the plan and rescue pack alone (best usual care) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital admissions where the primary reason for admission is AECOPD | A binary outcome assessing incidence of at least one AECOPD over 12 months after randomisation where patients needed hospitalisation (defined by hospital discharge letter/coding). | 12 months post randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of self-reported AECOPD every 3 months | Self-reported AECOPD (including those for which admission is required) obtained by telephone calls | 3, 6, 9 and 12 months post randomisation | 
| Number of Self-reported antibiotic and steroid prescriptions for AECOPD | Self-reported number of hospitalisations due to AECOPD obtained by telephone calls | 3, 6, 9 and 12 months post randomisation | 
| Number of all cause hospital admissions | All cause hospital admission taken from Hospital Episode Statistics (HES) and/or participant self-report | 12 months post randomisation | 
| Number of readmissions to hospital for AECOPD at 30 and 90 days | Readmissions to hospital for AECOPD at 30 and 90 days taken from HES and/or participant self-report | 12 months post randomisation | 
| Number of Bed days due to AECOPD | Total in hospital bed days due to AECOPD taken from HES and/or participant self-report | 12 months post randomisation | 
| Number of participant deaths from all causes | All-cause mortality taken from HES and/or medical records | 12 months post randomisation | 
| Number of unscheduled GP visits for AECOPD | Self-reported unscheduled GP visits for AECOPD | 12 months post randomisation | 
| Number of prescriptions for 2nd courses of antibiotics within 14 days of self-reported event (defined as treatment failure) | Self-reported prescriptions for 2nd courses of antibiotics within 14 days of self-reported | 12 months post randomisation | 
| Number of prescriptions for oral anti-fungals | Self-reported prescriptions for oral anti-fungals (e.g. for oral thrush) | 12 months post randomisation | 
| Quality of life by COPD assessment test | Quality of life measured using the COPD assessment test (CAT) at 3 monthly intervals | 3, 6, 9 and 12 months post randomisation | 
| Quality of life measured using the EuroQoL-5Dimension-5Level questionnaire | Measured at 3 monthly intervals. The EQ-5D-5L generates a score from 5 to 25 (5 being 'no problem' on all of the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression), the total score will be used for the economic evaluation only | 3, 6, 9 and 12 months post randomisation | 
| Antibiotic resistance | identification of antibiotic resistant pathogens within sputum culture | at baseline, all AECOPD and 12 months post randomisation | 
| Healthcare resource utilisation | determined from participant self-report on bespoke questionnaire (in development) | 3, 6 and 9 and 12 months post randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airflow Obstruction,, Chronic COAD, COPD, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, Chronic Obstructive Pulmonary Disease, Primary Care, Primary Healthcare, Patient Care, Chronic Bronchitis, Sputum