The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 3) (CAPTURE)
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- STATUS
- Recruiting
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- End date
- Feb 28, 2023
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- participants needed
- 5000
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- sponsor
- Weill Medical College of Cornell University
Summary
A prospective, multicenter study including a cross-section validation to define sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant Chronic Obstructive Pulmonary Disease (COPD), and its impact on clinical care across a broad range of primary care settings in a cluster randomized controlled clinical trial.
Description
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 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.
Details
| Condition | Chronic Obstructive Pulmonary Disease (COPD) |
|---|---|
| Treatment | COPD plus CAPTURE education and patient-level information, COPD Education Only |
| Clinical Study Identifier | NCT03583099 |
| Sponsor | Weill Medical College of Cornell University |
| Last Modified on | 25 March 2022 |
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