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

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ClinicalTrials.gov Identifier: NCT03583099
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : January 4, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
National Jewish Health
Atrium Health
Duke University
High Plains Research Network
L.A. Net Community Health Resource Network
Oregon Health and Science University
University of Kentucky
University of Minnesota
COPD Foundation
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Other: COPD plus CAPTURE education and patient-level information Other: COPD Education Only Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
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)
Masking Description:

Practitioners at sites randomized to the COPD education only intervention will be blinded to CAPTURE scores.

Practitioners in both intervention arms will be blinded to research spirometry results.

Participants will be blinded to spirometry results.

Primary Purpose: Other
Official Title: The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: CAPTURE + COPD Education
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.
Other: COPD plus CAPTURE education and patient-level information
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.

Active Comparator: COPD Education
Practice clinicians will receive basic COPD education only.
Other: COPD Education Only
Practice clinicians will receive basic COPD education only. Patient-level CAPTURE information will not be provided.




Primary Outcome Measures :
  1. Proportion of CAPTURE+ participants who meet a composite endpoint for diagnosis and management of COPD [ Time Frame: Baseline to 12 months ]
    Proportion of CAPTURE+ participants who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), or 4) referral to a specialist for respiratory evaluation/treatment CAPTURE+ is defined as Participants with: CAPTURE score > 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females


Secondary Outcome Measures :
  1. Proportion of CAPTURE+ participants who are referred for or completion of clinical spirometry testing [ Time Frame: Baseline to 12 months ]
    Proportion of CAPTURE+ participants who are referred for or completion of clinical spirometry testing

  2. Proportion of CAPTURE+ participants who are newly diagnosed with COPD [ Time Frame: Baseline to 12 months ]
    Proportion of CAPTURE+ participants who are newly diagnosed with COPD

  3. Proportion of CAPTURE+ participants with newly prescribed respiratory medication [ Time Frame: Baseline to 12 months ]
    Proportion of CAPTURE+ participants with newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition)

  4. Proportion of CAPTURE+ participants referred to a specialist for respiratory evaluation/treatment [ Time Frame: Baseline to 12 months ]
    Proportion of CAPTURE+ participants referred to a specialist for respiratory evaluation/treatment.

  5. Incidence of physician referral to a formal smoking cessation program in subjects with clinically significant COPD and are current smokers [ Time Frame: Baseline to 12 months ]
    Incidence of physician referral to a formal smoking cessation program in subjects with clinically significant COPD, defined as post-bronchodilator forced expiratory volume at 1 second/forced vital capacity (FEV1/FVC) < 0.7, plus one of the following: FEV1 < 60% predicted, or > 1 exacerbation-like event within the past 12 months, and are current smokers.

  6. Incidence of physician referral to pulmonary rehabilitation program in subjects with clinically significant COPD and are current smokers [ Time Frame: Baseline to 12 months ]
    Incidence of physician referral to pulmonary rehabilitation program in subjects with clinically significant COPD and are current smokers, defined as post-bronchodilator FEV1/FVC < 0.7, plus one of the following: FEV1 < 60% predicted, or > 1 exacerbation-like event within the past 12 months, and are current smokers

  7. Incidence of physician prescribed smoking cessation medication in subjects with clinically significant COPD and are current smokers [ Time Frame: Baseline to 12 months ]
    Incidence of physician prescribed smoking cessation medication in subjects with clinically significant COPD, defined as post-bronchodilator FEV1/FVC < 0.7, plus one of the following: FEV1 < 60% predicted, or > 1 exacerbation-like event within the past 12 months, and are current smokers

  8. Incidence of physician referral to a formal smoking cessation program in subjects with spirometrcially defined COPD and are current smokers [ Time Frame: Baseline to 12 months ]
    Incidence of physician referral to a formal smoking cessation program in subjects with spirometrcially defined COPD (post-bronchodilator FEV1/FVC < 0.70)

  9. Incidence of physician prescribed smoking cessation medication in subjects with spirometrcially defined COPD and are current smokers [ Time Frame: Baseline to 12 months ]
    Incidence of physician prescribed smoking cessation medication in subjects with spirometrcially defined COPD (post-bronchodilator FEV1/FVC < 0.70) and are current smokers

  10. Incidence of physician referral to pulmonary rehabilitation program in subjects with spirometrcially defined COPD and are current smokers [ Time Frame: Baseline to 12 months ]
    Incidence of physician referral to pulmonary rehabilitation program in subjects with spirometrcially defined COPD (post-bronchodilator FEV1/FVC < 0.70) and are current smokers

  11. Change in COPD Assessment Test (CAT) score in participants with clinically significant COPD [ Time Frame: Baseline to 12 months ]
    Change in CAT score in participants with clinically significant COPD

  12. Change in COPD Assessment Test (CAT) score in participants with spirometrically defined COPD [ Time Frame: Baseline to 12 months ]
    Change in COPD Assessment Test (CAT) score in participants with spirometrically defined COPD (post-bronchodilator FEV1/FVC < 0.70)

  13. Proportion of participants with clinically significant COPD who experience exacerbations, hospitalizations, or mortality [ Time Frame: Baseline to 12 months ]
    Proportion of participants with clinically significant COPD who experience exacerbations, hospitalizations, or mortality

  14. Proportion of participants with spirometrically defined COPD who experience exacerbations, hospitalizations, or mortality [ Time Frame: Baseline to 12 months ]
    Proportion of participants with spirometrically defined COPD, (post-bronchodilator FEV1/FVC < 0.70) who experience exacerbations, hospitalizations, or mortality

  15. Proportion of participants with spirometrically defined COPD who meet a composite endpoint for diagnosis and management of COPD [ Time Frame: Baseline to 12 months ]
    Proportion of participants with spirometrically defined COPD who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), or 4) referral to a specialist for respiratory evaluation/treatment CAPTURE+ is defined as Participants with: CAPTURE score > 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as <350 L/min for males and <250 L/min for females



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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

    1. Chest surgery
    2. Abdominal surgery
    3. Eye surgery
    4. Heart attack
    5. Stroke

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583099


Contacts
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Contact: Fernando J Martinez, MD, MS 646-962-2748 fjm2003@med.cornell.edu
Contact: Elizabeth Peters, BSN, RN 646-962-2742 elp2018@med.cornell.edu

Locations
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United States, California
LANet Not yet recruiting
Los Angeles, California, United States, 90802
Contact: Lyndee Knox, PhD    562-434-2000    lyndee.knox@gmail.com   
United States, Colorado
High Plains Research Network Not yet recruiting
Aurora, Colorado, United States, 80054
Contact: Linda Zittleman, MSPH    303-724-9716    linda.zittleman@ucdenver.edu   
United States, Florida
COPD Foundation Not yet recruiting
Miami, Florida, United States, 33134
Contact: Barbara Yawn, MD       Byawn@copdfoundation.org   
United States, North Carolina
Atrium Healthcare Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Hazel Tapp, PhD    704-304-7120    Hazel.Tapp@atriumhealth.org   
Duke University Recruiting
Durham, North Carolina, United States, 27701
Contact: Rowena Dolor, MD    919-668-8627    rowena.dolor@duke.edu   
United States, Oregon
Oregon Rural Practice-based Research Network (ORPRN) Recruiting
Portland, Oregon, United States, 97239
Contact: Lyle J Fagnan, MD    503-494-0361    fagnanl@ohsu.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
National Jewish Health
Atrium Health
Duke University
High Plains Research Network
L.A. Net Community Health Resource Network
Oregon Health and Science University
University of Kentucky
University of Minnesota
COPD Foundation
Investigators
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Principal Investigator: Fernando J Martinez, MD, MS Weill Cornell Medicine
Principal Investigator: MeiLan Han, MD, MS University of Michigan

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03583099     History of Changes
Other Study ID Numbers: 1803019032-3
R01HL136682-01 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases