Study recruiting; initiated September 2018
ClinicalTrials.gov Identifier: NCT03583099
The CAPTURE Study: Validating a Unique COPD Case-Finding Tool in Primary Care and Assessing its Impact in Primary Care Practices.
Study Sponsor: Weill Medical College of Cornell University
Study Funded by: the National Heart, Lung and Blood Institute of the National Institutes of Health with additional support from grants from industry.
Industry Advisory Committee members: Boehringer Ingelheim, AstraZeneca, Teva, Sunovion and GSK
COPD Foundation Principal Investigator: Barbara Yawn, MD MSc
Why do the study?
Many individuals with COPD are unrecognized, not diagnosed and undertreated. These individuals experience poor health status, chronic respiratory symptoms with acute worsening events, increased mortality and high use of health care.
The CAPTURE (COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk) COPD screening tool uses five questions combined with peak expiratory flow to find people at high risk of "clinically significant COPD" defined as people whose "COPD symptoms are likely to benefit from currently available therapies". The study is done in primary care practices where most COPD is diagnosed and managed.
- Martinez F, Mannino D, Leidy NK, et al. A new approach for identifying patients with undiagnosed chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2016; 195(6):748-756. doi: https://doi.org/10.1164/rccm.201603-0622OC
- Leidy NK, Martinez FJ, Malley KG, et al. Can CAPTURE be used to identify undiagnosed patients with mild-to-moderate COPD likely to benefit from treatment? Int J Chron Obstruct Pulmon Dis. 2018; 13:1901-1912. doi: https://doi.org/10.2147/COPD.S152226
The long-term goal is to identify people with undiagnosed but symptomatic COPD so they can begin therapy, to improve their health, prevent acute exacerbations and enhance their quality of life.
About the study
This multi-center, randomized and controlled pragmatic study (meaning it is done in real-world settings) explores the impact of screening with the CAPTURE tool on clinical care and patient outcomes across a broad range of primary care settings.
The study will enroll approximately 5,000 patients 40 years and older without a diagnosis of COPD across 100 participating primary care clinics associated with Practice-Based Research Networks (PBRNs).
The Agency for Health Care Research and Quality defines PBRNs as:
"PBRNs are groups of primary care clinicians and practices working together to answer community-based health care questions and translate research findings into practice. PBRNs engage clinicians in quality improvement activities and an evidence-based culture in primary care practice to improve the health of all Americans."
Study participants will be assessed with the CAPTURE Tool (questions and peak flow), answer questions about their health and have research lung function test (spirometry).
The study has two arms:
Arm 1: Practice clinicians will receive basic COPD education and patient-level CAPTURE information with CAPTURE interpretation education (CAPTURE+ COPD education).
Arm 2: Practice clinicians will receive basic COPD education only (COPD education) and will be blinded to patient-level CAPTURE information.
A pre-defined subgroup of participants will have a follow-up at 12 months to determine the impact of the CAPTURE Tool on clinical care and patient outcomes.
Data will be collected to assess:
- Is CAPTURE effective in identifying individuals with clinically significant COPD?
- Does CAPTURE work in primary care settings?
- Does CAPTURE make a difference in the lives of patients with previously undiagnosed, clinically significant COPD?
- Frequency of 2019 novel coronavirus infections (COVID-19)
Continuing COVID-19-related respiratory symptoms in patients previously diagnosed with COVID-19
Medications following COVID-19 disease
The impact of COVID-19 on the accuracy of CAPTURE screening
The approach is highly innovative and clinically relevant as it applies a rigorously developed, novel COPD case-finding approach to identifying COPD patients most likely to benefit from available therapy. The results will change the paradigm for COPD diagnosis in primary care and change COPD recommendations globally.
- University of Michigan
- National Jewish Health
- University of Kentucky
- University of Minnesota
- Atrium Health
- Duke University
- High Plains Research Network
- L.A. Net Community Health Resource Network
- Oregon Health and Science University
- University of Illinois at Chicago and Cook County Health
Interested in learning more?
Contact Elisha Malanga at email@example.com