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

Sponsor

University of Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04705233

Collaborator

Northern Care Alliance NHS Foundation Trust (Other)

2,954

Enrollment

Arms

30.8

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Other: sputum colour chart	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2954 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A 2 arm, multi-centre, open label, parallel-group randomised designed trialA 2 arm, multi-centre, open label, parallel-group randomised designed trial

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jun 7, 2021

Anticipated Primary Completion Date :

Mar 4, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sputum chart 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 5-point Sputum Colour Chart plus best standard care
No Intervention: Control Use of the plan and rescue pack alone (best usual care)

Arm

Intervention/Treatment

Experimental: Sputum chart

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

5-point Sputum Colour Chart plus best standard care

No Intervention: Control

Use of the plan and rescue pack alone (best usual care)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 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 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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.