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

NCT03583099 | Completed Results DMC

• 2 other identifiers: 1803019032-3R01HL136682-01
• Study Type: interventional
• Target: 2,004
• Locations: 1 country
• Sites: 9

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD

  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), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. 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. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

  Baseline to 12 months

Secondary Outcomes (149)

• Proportion of CAPTURE+ Participants Who Are Referred for or Complete Clinical Spirometry Testing

  Baseline to 12 months

• Proportion of CAPTURE+ Participants Who Are Newly Diagnosed With COPD

  Baseline to 12 months

• Proportion of CAPTURE+ Participants With Newly Prescribed Respiratory Medication

  Baseline to 12 months

• Proportion of CAPTURE+ Participants Referred to a Specialist for Respiratory Evaluation/Treatment

  Baseline to 12 months

• Proportion of CAPTURE+ Participants Who Are Referred for or Complete Pulmonary Rehabilitation

  Baseline to 12 months

Study Arms (2)

COPD Education

ACTIVE COMPARATOR

Practice clinicians will receive basic COPD education only.

Other: COPD Education Only

CAPTURE + COPD Education

EXPERIMENTAL

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

Interventions

COPD plus CAPTURE education and patient-level information OTHER

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.

CAPTURE + COPD Education

COPD Education Only OTHER

Practice clinicians will receive basic COPD education only. Patient-level CAPTURE information will not be provided.

COPD Education

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Previous clinician provided diagnosis of COPD
• \. Treated respiratory infection (with antibiotics and/or systemic steroids) in the past 30 days
• \. Participants unable to perform spirometry due to any of the following conditions within the past 30 days
• Chest surgery
• Abdominal surgery
• Eye surgery
• Heart attack
• Stroke

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Michigan: collaborator
• National Jewish Health: collaborator
• Wake Forest University Health Sciences: collaborator
• Duke University: collaborator
• High Plains Research Network: collaborator
• L.A. Net Community Health Resource Network: collaborator
• Oregon Health and Science University: collaborator
• University of Kentucky: collaborator
• University of Minnesota: collaborator
• COPD Foundation: collaborator

Study Sites (9)

LANet

Los Angeles, California, 90802, United States

Location

High Plains Research Network

Aurora, Colorado, 80054, United States

Location

COPD Foundation

Miami, Florida, 33134, United States

Location

Cook County Hospital

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Circuit Clinical

Buffalo, New York, 14203, United States

Location

Atrium Healthcare

Charlotte, North Carolina, 28207, United States

Location

Duke University

Durham, North Carolina, 27701, United States

Location

Oregon Rural Practice-based Research Network (ORPRN)

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.

  PMID: 35514131 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Fernando J. Martinez, MD, MS
• Organization: Weill Cornell Medicine

fjm2003@med.cornell.edu

646-962-2370

Study Officials

• Fernando J Martinez, MD, MS

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• MeiLan Han, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: July 11, 2018
• Study Start: October 12, 2018
• Primary Completion: April 7, 2023
• Study Completion: April 7, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Locations

US (9)