The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 3)

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Other: COPD Education Only; Other: COPD plus CAPTURE education and patient-level information

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT03583099

R01HL136682-01 (U.S. NIH Grant/Contract)

1803019032-3

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 2,004 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. Provision of signed and dated informed consent form
• 2. Stated willingness to comply with all study procedures and availability for the duration of the study
• 3. Male or female, aged 45 - 80 years
• 4. Able to read and speak English or Spanish

Exclusion criteria

• 1. Previous clinician provided diagnosis of COPD
• 2. Treated respiratory infection (with antibiotics and/or systemic steroids) in the past 30 days

• 3. Participants unable to perform spirometry due to any of the following conditions within the past 30 days

  4. Chest surgery

  5. Abdominal surgery

  6. Eye surgery

  7. Heart attack

  8. Stroke

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,004 participants in 2 patient groups

COPD Education

Active Comparator group

Description:

Practice clinicians will receive basic COPD education only.

Treatment:

Other: COPD Education Only

CAPTURE + COPD Education

Experimental group

Description:

Practice clinicians will receive basic COPD education, and patient-level CAPTURE information with CAPTURE interpretation education. As the second aim address the optimal format for delivering practice CAPTURE education this will be incorporated at the sites randomized to this arm.

Treatment:

Other: COPD plus CAPTURE education and patient-level information