The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 3)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

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.
    

Detailed 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.

      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.
    

Intervention name(s): COPD plus CAPTURE education and patient-level information; COPD Education Only
Intervention type(s): Other; Other
Intervention description(s): Basic COPD Education plus CAPTURE education and patient-level CAPTURE information will be provided to all practice personnel randomized to the 'CAPTURE + COPD Education' arm.; Practice clinicians will receive basic COPD education only. Patient-level CAPTURE information will not be provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participating primary practices will be randomized to one of 2 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).
Masking: Double (Participant, Care Provider)
Primary purpose: Other