Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
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
Brief summary
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
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.
Interventions
OTHERsputum colour chart
5-point Sputum Colour Chart plus best standard care
Sponsors
Salford Royal Foundation Trust
University of Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
A 2 arm, multi-centre, open label, parallel-group randomised designed trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of hospital admissions where the primary reason for admission is AECOPD | 12 months post randomisation | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Self-reported antibiotic and steroid prescriptions for AECOPD | 3, 6, 9 and 12 months post randomisation | Self-reported number of hospitalisations due to AECOPD obtained by telephone calls |
| Number of all cause hospital admissions | 12 months post randomisation | All cause hospital admission taken from Hospital Episode Statistics (HES) and/or participant self-report |
| Number of readmissions to hospital for AECOPD at 30 and 90 days | 12 months post randomisation | Readmissions to hospital for AECOPD at 30 and 90 days taken from HES and/or participant self-report |
| Number of Bed days due to AECOPD | 12 months post randomisation | Total in hospital bed days due to AECOPD taken from HES and/or participant self-report |
| Number of participant deaths from all causes | 12 months post randomisation | All-cause mortality taken from HES and/or medical records |
| Number of unscheduled GP visits for AECOPD | 12 months post randomisation | Self-reported unscheduled GP visits for AECOPD |
| Number of self-reported AECOPD every 3 months | 3, 6, 9 and 12 months post randomisation | Self-reported AECOPD (including those for which admission is required) obtained by telephone calls |
| Number of prescriptions for oral anti-fungals | 12 months post randomisation | Self-reported prescriptions for oral anti-fungals (e.g. for oral thrush) |
| Quality of life by COPD assessment test | 3, 6, 9 and 12 months post randomisation | Quality of life measured using the COPD assessment test (CAT) at 3 monthly intervals |
| Quality of life measured using the EuroQoL-5Dimension-5Level questionnaire | 3, 6, 9 and 12 months post randomisation | 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 |
| Antibiotic resistance | at baseline, all AECOPD and 12 months post randomisation | identification of antibiotic resistant pathogens within sputum culture |
| Healthcare resource utilisation | 3, 6 and 9 and 12 months post randomisation | determined from participant self-report on bespoke questionnaire (in development) |
| Number of prescriptions for 2nd courses of antibiotics within 14 days of self-reported event (defined as treatment failure) | 12 months post randomisation | Self-reported prescriptions for 2nd courses of antibiotics within 14 days of self-reported |
Countries
United Kingdom
Contacts
Primary ContactSarah Moorlock
Backup ContactSarah Tearne
Outcome results
None listed