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

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03583099
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), University of Michigan (Other), National Jewish Health (Other), Wake Forest University Health Sciences (Other), Duke University (Other), High Plains Research Network (Other), L.A. Net Community Health Resource Network (Other), Oregon Health and Science University (Other), University of Kentucky (Other), University of Minnesota (Other), COPD Foundation (Other)
• Enrollment: 5,000
• Locations: 9
• Arms: 2
• Anticipated Duration (Months): 55.1
• Patients Per Site: 555.6
• Patients Per Site Per Month: 10.1

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated 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).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: Sep 17, 2018
• Anticipated Primary Completion Date: Apr 22, 2023
• Anticipated Study Completion Date: Apr 22, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Proportion of CAPTURE+ participants who meet a composite endpoint for diagnosis and management of COPD [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 [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 [Baseline to 12 months]

   Proportion of CAPTURE+ participants who are newly diagnosed with COPD

3. Proportion of CAPTURE+ participants with newly prescribed respiratory medication [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LANet	Los Angeles	California	United States	90802
2	High Plains Research Network	Aurora	Colorado	United States	80054
3	COPD Foundation	Miami	Florida	United States	33134
4	Cook County Hospital	Chicago	Illinois	United States	60612
5	University of Illinois at Chicago	Chicago	Illinois	United States	60612
6	Circuit Clinical	Buffalo	New York	United States	14203
7	Atrium Healthcare	Charlotte	North Carolina	United States	28207
8	Duke University	Durham	North Carolina	United States	27701
9	Oregon Rural Practice-based Research Network (ORPRN)	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Weill Medical College of Cornell University
• National Heart, Lung, and Blood Institute (NHLBI)
• University of Michigan
• National Jewish Health
• Wake Forest University Health Sciences
• 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

• Principal Investigator: Fernando J Martinez, MD, MS, Weill Medical College of Cornell University
• Principal Investigator: MeiLan Han, MD, MS, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03583099
• Other Study ID Numbers: 1803019032-3; R01HL136682-01
• First Posted: Jul 11, 2018
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

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

Study Results

No Results Posted as of Jul 28, 2022