Effectiveness-implementation of COPD case finding and self-management action plans in low- and middle-income countries: global excellence in COPD outcomes (GECo) study protocol

Abstract

Background: Chronic obstructive pulmonary disease (COPD) is the end result of a susceptible individual being exposed to sufficiently deleterious environmental stimuli. More than 90% of COPD-related deaths occur in low- and middle-income countries (LMICs). LMICs face unique challenges in managing COPD; for example, deficient primary care systems present challenges for proper diagnosis and management. Formal diagnosis of COPD requires quality-assured spirometry, which is often limited to urban health centres. Similarly, standard treatment options for COPD remain limited where few providers are trained to manage COPD. The Global Excellence in COPD Outcomes (GECo) studies aim to assess the performance of a COPD case-finding questionnaire with and without peak expiratory flow (PEF) to diagnose COPD, and inform the effectiveness and implementation of COPD self-management Action Plans in LMIC settings. The ultimate goal is to develop simple, low-cost models of care that can be implemented in LMICs. This study will be carried out in Nepal, Peru and Uganda, three distinct LMIC settings.

Methods/design: We aim to assess the diagnostic accuracy of a simple questionnaire with and without PEF to case-find COPD (GECo1), and examine the effectiveness, cost-effectiveness and implementation of a community-health-worker-supported self-management Action Plan strategy for managing exacerbations of COPD (GECo2). To achieve the first aim, we will enrol a randomly selected sample of up to 10,500 adults aged ≥ 40 years across our three sites, with the goal to enrol 240 participants with moderate-to-severe COPD in to GECo2. We will apply two case-finding questionnaires (Lung Function Questionnaire and CAPTURE) with and without PEF and compare performance against spirometry. We will report ROC areas, sensitivity and specificity. Individuals who are identified as having COPD grades B-D will be invited to enrol in an effectiveness-implementation hybrid randomised trial of a multi-faceted COPD self-management Action Plan intervention delivered by CHWs. The intervention group will receive (1) COPD education, (2) facilitated-self management Action Plans for COPD exacerbations and (3) monthly visits by community health workers. The control group will receive COPD education and standard of care treatment provided by local health providers. Beginning at baseline, we will measure quality of life with the EuroQol-5D (EQ-5D) and St. George's Respiratory Questionnaire (SGRQ) every 3 months over a period of 1 year. The primary endpoint is SGRQ at 12 months. Quality-adjusted life years (QALYs) using the Short-Form 36 version 2 will also be calculated. We will additionally assess the acceptability and feasibility of implementing COPD Action Plans in each setting among providers and individuals with COPD.

Discussion: This study should provide evidence to inform the use of pragmatic models of COPD diagnosis and management in LMIC settings.

Trial registration: NCT03359915 (GECo1). Registered on 2 December 2017 and NCT03365713 (GECo2). Registered on 7 December 2017. Trial acronym: Global Excellence in COPD Outcomes (GECo1; GECo2).

Keywords: COPD; COPD action plan; COPD case finding; COPD exacerbations; Non-communicable disease; Self-management.

Conflict of interest statement

Ethics approval and consent to participate

The trial has been reviewed and approved by the University College London Research Ethics Committee (9661/001), Johns Hopkins School of Medicine (IRB00139901), Uganda National Council for Science and Technology, Makerere School of Medicine (SOMREC 2017–096), Nepal Health Research Council (136/2017) and A.B. PRIMSA (CE2147.17). Additionally, the trials have been registered at ClinicalTrials.gov (GECo1: NCT03359915, and GECo2: NCT03365713).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Overview of the GECo Studies

Fig. 2

Schedule of enrolment, interventions and assessments

Fig. 3

Chronic obstructive pulmonary disease (COPD) self-management Action Plan. Action plans will be distributed to the intervention arm of trial in addition to medication rescue packs. Sections are colour-coded (green – usual care, yellow – COPD exacerbation self-management, red – urgent medical care)

Fig. 4

Rescue pack for chronic obstructive pulmonary disease (COPD) exacerbations. Medications based on GOLD recommendation for treatment of COPD exacerbations and local prescribing practices

Fig. 5

GECo 2 follow-up. Participants will be followed quarterly and queried on exacerbation history and healthcare utilisation. St. George’s Respiratory Questionnaire (SGRQ) will be administered 6-monthly, EuroQol-5D and health-costing surveys will be administered quarterly