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

Trishul Siddharthan, Suzanne L. Pollard, Shumonta A. Quaderi, Andrew J. Mirelman, Maria Kathia Cárdenas, Bruce Kirenga, Natalie A. Rykiel, J. Jaime Miranda, Laxman Shrestha, Ram K. Chandyo, Adithya Cattamanchi, Susan Michie, Julie Barber, William Checkley, John R. Hurst, John R. Hurst, Zachos Anastasiou, Suzanne L. Pollard, Brooks Morgan, Natalie A. RykielMathew Grigsby, Nicole Robertson, Robert A. Wise, Karbir Nath Yogi, Arun Sharma, Ram K. Chandyo, Patricia Alupo, Denis Muwonge, Denis Mawanda, Faith Nassali, Robert Kalyesubula, Andrew J. Mirelman, Marta Soares, Oscar Flores-Flores, Elisa Romani-Huacani

Research output: Contribution to journalArticle

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).

Original languageEnglish (US)
Article number571
JournalTrials
Volume19
Issue number1
DOIs
StatePublished - Oct 19 2018

Fingerprint

Self Care
Chronic Obstructive Pulmonary Disease
Outcome Assessment (Health Care)
Disease Management
Spirometry
Urban Health
Education
Nepal
Peru
Uganda
Quality-Adjusted Life Years

Keywords

  • COPD
  • COPD action plan
  • COPD case finding
  • COPD exacerbations
  • Non-communicable disease
  • Self-management

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

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. / Siddharthan, Trishul; Pollard, Suzanne L.; Quaderi, Shumonta A.; Mirelman, Andrew J.; Cárdenas, Maria Kathia; Kirenga, Bruce; Rykiel, Natalie A.; Miranda, J. Jaime; Shrestha, Laxman; Chandyo, Ram K.; Cattamanchi, Adithya; Michie, Susan; Barber, Julie; Checkley, William; Hurst, John R.; Hurst, John R.; Anastasiou, Zachos; Pollard, Suzanne L.; Morgan, Brooks; Rykiel, Natalie A.; Grigsby, Mathew; Robertson, Nicole; Wise, Robert A.; Yogi, Karbir Nath; Sharma, Arun; Chandyo, Ram K.; Alupo, Patricia; Muwonge, Denis; Mawanda, Denis; Nassali, Faith; Kalyesubula, Robert; Mirelman, Andrew J.; Soares, Marta; Flores-Flores, Oscar; Romani-Huacani, Elisa.

In: Trials, Vol. 19, No. 1, 571, 19.10.2018.

Research output: Contribution to journalArticle

Siddharthan, T, Pollard, SL, Quaderi, SA, Mirelman, AJ, Cárdenas, MK, Kirenga, B, Rykiel, NA, Miranda, JJ, Shrestha, L, Chandyo, RK, Cattamanchi, A, Michie, S, Barber, J, Checkley, W, Hurst, JR, Hurst, JR, Anastasiou, Z, Pollard, SL, Morgan, B, Rykiel, NA, Grigsby, M, Robertson, N, Wise, RA, Yogi, KN, Sharma, A, Chandyo, RK, Alupo, P, Muwonge, D, Mawanda, D, Nassali, F, Kalyesubula, R, Mirelman, AJ, Soares, M, Flores-Flores, O & Romani-Huacani, E 2018, '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', Trials, vol. 19, no. 1, 571. https://doi.org/10.1186/s13063-018-2909-8
Siddharthan, Trishul ; Pollard, Suzanne L. ; Quaderi, Shumonta A. ; Mirelman, Andrew J. ; Cárdenas, Maria Kathia ; Kirenga, Bruce ; Rykiel, Natalie A. ; Miranda, J. Jaime ; Shrestha, Laxman ; Chandyo, Ram K. ; Cattamanchi, Adithya ; Michie, Susan ; Barber, Julie ; Checkley, William ; Hurst, John R. ; Hurst, John R. ; Anastasiou, Zachos ; Pollard, Suzanne L. ; Morgan, Brooks ; Rykiel, Natalie A. ; Grigsby, Mathew ; Robertson, Nicole ; Wise, Robert A. ; Yogi, Karbir Nath ; Sharma, Arun ; Chandyo, Ram K. ; Alupo, Patricia ; Muwonge, Denis ; Mawanda, Denis ; Nassali, Faith ; Kalyesubula, Robert ; Mirelman, Andrew J. ; Soares, Marta ; Flores-Flores, Oscar ; Romani-Huacani, Elisa. / 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. In: Trials. 2018 ; Vol. 19, No. 1.
@article{5b60c38b08be4661a22d5b2c9cb477a5,
title = "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",
author = "Trishul Siddharthan and Pollard, {Suzanne L.} and Quaderi, {Shumonta A.} and Mirelman, {Andrew J.} and C{\'a}rdenas, {Maria Kathia} and Bruce Kirenga and Rykiel, {Natalie A.} and Miranda, {J. Jaime} and Laxman Shrestha and Chandyo, {Ram K.} and Adithya Cattamanchi and Susan Michie and Julie Barber and William Checkley and Hurst, {John R.} and Hurst, {John R.} and Zachos Anastasiou and Pollard, {Suzanne L.} and Brooks Morgan and Rykiel, {Natalie A.} and Mathew Grigsby and Nicole Robertson and Wise, {Robert A.} and Yogi, {Karbir Nath} and Arun Sharma and Chandyo, {Ram K.} and Patricia Alupo and Denis Muwonge and Denis Mawanda and Faith Nassali and Robert Kalyesubula and Mirelman, {Andrew J.} and Marta Soares and Oscar Flores-Flores and Elisa Romani-Huacani",
year = "2018",
month = "10",
day = "19",
doi = "10.1186/s13063-018-2909-8",
language = "English (US)",
volume = "19",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Effectiveness-implementation of COPD case finding and self-management action plans in low- and middle-income countries

T2 - Global excellence in COPD outcomes (GECo) study protocol

AU - Siddharthan, Trishul

AU - Pollard, Suzanne L.

AU - Quaderi, Shumonta A.

AU - Mirelman, Andrew J.

AU - Cárdenas, Maria Kathia

AU - Kirenga, Bruce

AU - Rykiel, Natalie A.

AU - Miranda, J. Jaime

AU - Shrestha, Laxman

AU - Chandyo, Ram K.

AU - Cattamanchi, Adithya

AU - Michie, Susan

AU - Barber, Julie

AU - Checkley, William

AU - Hurst, John R.

AU - Hurst, John R.

AU - Anastasiou, Zachos

AU - Pollard, Suzanne L.

AU - Morgan, Brooks

AU - Rykiel, Natalie A.

AU - Grigsby, Mathew

AU - Robertson, Nicole

AU - Wise, Robert A.

AU - Yogi, Karbir Nath

AU - Sharma, Arun

AU - Chandyo, Ram K.

AU - Alupo, Patricia

AU - Muwonge, Denis

AU - Mawanda, Denis

AU - Nassali, Faith

AU - Kalyesubula, Robert

AU - Mirelman, Andrew J.

AU - Soares, Marta

AU - Flores-Flores, Oscar

AU - Romani-Huacani, Elisa

PY - 2018/10/19

Y1 - 2018/10/19

N2 - 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).

AB - 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).

KW - COPD

KW - COPD action plan

KW - COPD case finding

KW - COPD exacerbations

KW - Non-communicable disease

KW - Self-management

UR - http://www.scopus.com/inward/record.url?scp=85055079770&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85055079770&partnerID=8YFLogxK

U2 - 10.1186/s13063-018-2909-8

DO - 10.1186/s13063-018-2909-8

M3 - Article

C2 - 30340648

AN - SCOPUS:85055079770

VL - 19

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 571

ER -