Finding studies
Finding studies
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Lead
Weill Medical College of Cornell University
With
This is a large prospective, multi-center study explore the impact of the CAPTURE tool on clinical care and patient outcomes across a broad range of primary care settings in a cluster randomized controlled clinical trial. The CAPTURE tool consists of a 5-item self-administered questionnaire and selected use of peak expiratory flow (PEF) measurement, designed to identify clinically significant COPD. The CAPTURE study will enroll approximately 5,000 patients across 100 participating primary care clinics associated with practice-based research networks (PBRNs). Participants will be assessed with the CAPTURE Tool and have research spirometry testing. Participating primary care practices will be randomized in a 1:1 fashion to one of the following interventions: * 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 predefined subgroup of participants will undergo longitudinal follow-up at 12 months to determine the impact of the CAPTURE Tool on clinical care and patient outcomes. Participant reported data will be collected through in-person visits, telephone and mail-based methodologies, depending upon practice site preferences and feasibility. Clinic site data will also be collected from the medical record to assess for changes in practice-level care. Primary outcome measure changes have been made in this ClinicalTrials.gov record because a planned part of the primary outcome measure was inadvertently missing from the initial draft of the protocol. It has been added to this ClinicalTrials.gov record to align with the most recent IRB-approved protocol. Secondary outcome measure changes were initiated as driven by the literature and advances in accepted methods of management and categorization of patients with COPD. An additional secondary outcome measure was added due to the COVID-19 pandemic. The changes have been made in ClinicalTrials.gov to align with the most recent IRB-approved protocol.
Age
45–80
Sex
ALL
Healthy volunteers
Accepted
