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. 2021 Jan;8(1):60-75.
doi: 10.15326/jcopdf.2020.0155.

Protocol Summary of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) Validation in Primary Care Study

Barbara P Yawn  1   2 , Meilan Han  3 , Barry M Make  4 , David Mannino  5 , Randall W Brown  6 , Catherine Meldrum  3 , Susan Murray  7 , Cathie Spino  7 , Jacqueline S Bronicki  7 , Nancy Leidy  8 , Hazel Tapp  9 , Rowena J Dolor  10 , Min Joo  11 , Lyndee Knox  12 , Linda Zittleman  13 , Byron M Thomashow  14 , Fernando J Martinez  15
Affiliations

Protocol Summary of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) Validation in Primary Care Study

Barbara P Yawn et al. Chronic Obstr Pulm Dis. 2021 Jan.

Abstract

Chronic obstructive pulmonary disease (COPD) often remains undiagnosed and untreated. To date, COPD screening/case finding has not been designed to identify clinically significant COPD, disease ready for therapies beyond smoking cessation. Herein, we describe the ongoing prospective, pragmatic cluster-randomized controlled trial to assess specificity and sensitivity of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) tool consisting of 5 questions and peak expiratory flow. The tool is designed to identify clinically significant COPD (forced expiratory volume in 1 second [FEV1] to forced vital capacity [FVC] ratio <.70 plus FEV1% predicted <60% or increased risk for exacerbation) and the trial will explore the impact of CAPTURE-based screening on COPD diagnosis and treatment rates in primary care patients. Of a total planned enrollment of 5000 English- or Spanish-speaking patients 45 to 80 years of age without a prior COPD diagnosis from 100 primary care practices, a total of 68 practices and 3064 patients have been enrolled in the study. Practices are centrally randomized to either usual care or clinician receipt of patient-level CAPTURE results. All clinicians receive basic COPD education with those in intervention practices also receiving CAPTURE interpretation education. In a single visit, patient participants complete a CAPTURE screening, pre- and post-bronchodilator spirometry and baseline demographic and health questionnaires to validate CAPTURE sensitivity, specificity, and predictive value of identifying undiagnosed, clinically significant COPD. One-year follow-up chart reviews and participant surveys assess the impact of sharing versus not sharing CAPTURE results with clinicians on clinical outcomes including level of respiratory symptoms and events and clinicians' initiation of recommendation-concordant COPD care. This is one of the first U.S. studies to validate and assess impact of a simple COPD screening tool in primary care.

Keywords: CAPTURE; COPD; Case finding; practice-based research networks; primary care; screening; tool validation.

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Conflict of interest statement

B. Yawn has served on the advisory board of and received personal fees from: GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, Teva, nDD and Novartis. M. Han reports grants from the National Heart, Lung and Blood Institute, and the COPD Foundation, during the conduct of the study. She has received personal fees from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Merck and Mylan, and non-financial support from Novartis and Sunovion, outside the submitted work. B. Make reports serving on medical advisory boards for AstraZeneca, Boehringer Ingelheim, Circassia, GlaxoSmithKline, Sunovion, Theravance, Phillips, Science 24/7, Spiration, and Verona. In addition, he received research grants, controlled by National Jewish Health, from AstraZeneca, GlaxoSmithKline, Pearl, Sunovion, and the National Heart Lung and Blood Institute. He provided CME for the Academy for Continued Health Care Learning, the American College of Chest Physicians, Catamount Medical, Eastern Pulmonary Society, Eastern VA Medical Center, Hybrid Communications, Novartis, Mt. Sinai Medical Center, WebMD, Medscape, National Jewish Health, Projects in Knowledge, Ultimate Medical Academy and Wolters Kluwer Health. He has served on data safety monitoring boards for AstraZeneca, Shire, Spiration, and Takeda. D. Mannino was an employee and shareholder of GlaxoSmithKline at the time of this study. N. Leidy is employed by Evidera, a health care research firm that provides consulting and other research services to pharmaceutical, device, government, and non-government organizations. In this salaried position, Dr. Leidy works with a variety of companies and organizations but receives no payment or honoraria directly from these organizations for services rendered, with the exception of honoraria received for her advisor role on several National Institutes of Health and Food and Drug Administration-funded programs: PATIENTS, PCAR, and NUCOAT. F. Martinez reports receiving grants from GlaxoSmithKline during the conduct of the study. He has received personal fees from AstraZeneca, Boehringer Ingelheim, the Canadian Respiratory Society, CME Outfitters, CSL Behring, Dartmouth University, the France Foundation, Gala, Genentech, GlaxoSmithKline, Inova Fairfax, MDMagazine, NYP Methodist Hospital Brooklyn, Miller Communications the National Associate for Continuing Education, Novartis, New York University, Patara/Respivant, Pearl, Peer View, Physicians Education Resource, ProMedior, Rare Diseases Healthcare Communications, Rockpointe Communications, Sanofi/Regeneron, Sunovion, Teva, University of Alabama, Birmingham, UpToDate, Vindico, and WebMD/Medscape. He has received non-financial support from AstraZeneca, Boehringer Ingelheim, the Canadian Respiratory Society, CME Outfitters, CSL Behring, Genentech, GlaxoSmithKline, Inova Fairfax, MDMagazine, NYP Methodist Hospital Brooklyn, Miller Communications, the National Association for Continuing Education, Novartis, Patara/Respivant, Peer View, Rare Diseases Healthcare Communications, Sanofi/Regeneron, Sunovion, Teva, Veracyte, WebMD/Medscape, Zambon and ProTerrixBio. He has served on advisory board for AstraZeneca, Boehringer Ingelheim, Chiesi, CSLBering, Gala, Genentech, GlaxoSmithKline, Pearl,Sanofi/Regeneron, Sunovion, Teva, and Zambon and a steering committee for Afferent/Merck. Authors Brown, Meldrum, Murray, Spino, Bronicki, Tapp, Dolor, Joo, Knox, Zittleman, and Thomashow have nothing to declare.

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