Clinical trial NCT03583099: The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 3)
Official title: The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Michigan
name: National Jewish Health
name: Wake Forest University Health Sciences
name: Duke University
name: High Plains Research Network
name: L.A. Net Community Health Resource Network
name: Oregon Health and Science University
name: University of Kentucky
name: University of Minnesota
name: COPD Foundation
First posted: 2018-07-11
Enrollment: 2004
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: OTHER

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.

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 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.

Eligibility 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
* 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

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

Primary outcomes:
measure: Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Proportion of CAPTURE+ Participants Who Are Referred for or Complete Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Who Are Newly Diagnosed With COPD
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants With Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Who Are Referred for or Complete Pulmonary Rehabilitation
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Who Have Received a Recommendation for, or Administration of Influenza Vaccination.
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Smoking at the Baseline With Any Components of the Primary Endpoint OR Any of the 4 Events Described in the Description Below.
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Referred for or Complete Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a New Diagnosis of COPD
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral for, or Complete Pulmonary Rehabilitation.
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive Clinician Counseling or Recommendation for Smoking Cessation
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Smoking Cessation Program
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Capture Positive Participants Currently Smoking at Baseline Who Referral to a Smoking Quit Line
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Newly Prescribed Medication for Smoking Cessation.
timeFrame: Baseline to 12 months
measure: 12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Who Experience Exacerbations.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Who Meet Any of the Components of the Primary Endpoint.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD With a New Diagnosis of COPD
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD With a Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD With a Referral to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD With a Referral for or Completion of Pulmonary Rehabilitation.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Who Receive a Recommendation for or Administration of Influenza Vaccination
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Who Meet Any of the Components of the Primary Endpoint.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Referred for or Completion of Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD With a New Diagnosis of COPD.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD With Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Who Are Referred for or Complete Pulmonary Rehabilitation.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Who Receive a Recommendation for or Administration of Influenza Vaccination.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Who Meet Any of the Components of the Primary Endpoint
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Referred for or Completion of Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD With a New Diagnosis of COPD
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD With a Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Referred for or Completion of Pulmonary Rehabilitation.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Who Received a Recommendation or Administration of Influenza Vaccination.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Meet Any of the Components of the Primary Endpoint.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Clinical Spirometry Testing.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With New Diagnosis of COPD.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) With a Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Referred for or Completion of Pulmonary Rehabilitation.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Who Receive a Recommendation for or Administration of Influenza Vaccination.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Meet Any of the Components of the Primary Endpoint.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Clinical Spirometry Testing.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) With a New Diagnosis of COPD
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Referred for or Completion of Pulmonary Rehabilitation.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Who Receive a Recommendation or Administration of Influenza Vaccination.
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Newly Diagnosed With COPD
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Newly Diagnosed With COPD
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Have Received a Recommendation for, or Administration of Influenza Vaccination
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Have Received a Recommendation for, or Administration of Influenza Vaccination
timeFrame: Baseline to 12 months
measure: 12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled Before March 20, 2019
timeFrame: Baseline to 12 months
measure: 12-month Change in COPD Assessment Test (CAT) Score (12 Month CAT Change) in CAPTURE+ Participants Enrolled on or After March 20, 2019
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Exacerbations.
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Exacerbations.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Meet Any of Components of the Primary Endpoints.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 Who Meet Any of Components of the Primary Endpoints.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 a New Diagnosis of COPD
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled on or After March 20, 2019 With a Referral for or Completion of Pulmonary Rehabilitation
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description)
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Clinically Significant COPD Enrolled After August 13, 2020 Who Receive a Recommendation for or Administration of Influenza Vaccination
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description)
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 With Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 With Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment (Abbreviated as Proportion in the Description)
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Are Referred for or Complete Pulmonary Rehabilitation
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Spirometric COPD Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination
timeFrame: Baseline to 12 months
measure: Proportion of Mild COPD Participants Enrolled Before 3/20/2019 With Any of :1) Clinical Spirometry Referral, 2) New COPD Diagnosis, 3) Newly Prescribed Respiratory Medication, 4) Respiratory Specialist Referral, 5) Referral/Completion of Pulmonary Rehab
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing (Abbreviated as Proportion in the Description)
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description)
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a New Diagnosis of COPD
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication (Abbreviated as Proportion in the Description)
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Enrolled Before March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Mild COPD Enrolled on or After March 20, 2019 Who Received a Recommendation or Administration of Influenza Vaccination
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ration, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With New Diagnosis of COPD
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With New Diagnosis of COPD
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 With a Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 With a Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled Before March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination (Abbreviated as Proportion in the Description)
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Preserved Ratio, Impaired Spirometry (PRISm) Enrolled on or After March 20, 2019 Who Receive a Recommendation for or Administration of Influenza Vaccination
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Meet Any of the Components of the Primary Endpoint.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Clinical Spirometry Testing
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 With a New Diagnosis of COPD (Abbreviated as Proportion in the Description)
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 With a New Diagnosis of COPD
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Newly Prescribed Respiratory Medication
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred to a Specialist for Respiratory Evaluation/Treatment
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Referred for or Completion of Pulmonary Rehabilitation
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled Before March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination.
timeFrame: Baseline to 12 months
measure: Proportion of Participants With Symptomatic Non-obstructed (SNO) Enrolled on or After March 20, 2019 Who Receive a Recommendation or Administration of Influenza Vaccination.
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Received Over-the-counter Patches/Gum for Smoking Cessation
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Who Experience Hospitalizations
timeFrame: Baseline to 12 months
measure: Number of Enrolled CAPTURE+ Participants Who Experience Mortality
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Hospitalizations
timeFrame: Baseline to 12 months
measure: Proportion of CAPTURE+ Participants Enrolled on or After March 20, 2019 Who Experience Hospitalizations
timeFrame: Baseline to 12 months
measure: Number of CAPTURE+ Participants Enrolled Before March 20, 2019 Who Experience Mortality.
timeFrame: Baseline to 12 months
measure: Number of CAPTURE+ Participants Enrolled After March 20, 2019 Who Experience Mortality.
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LANet
state: California
city: Aurora
country: United States
facility: High Plains Research Network
state: Colorado
city: Miami
country: United States
facility: COPD Foundation
state: Florida
city: Chicago
country: United States
facility: Cook County Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Buffalo
country: United States
facility: Circuit Clinical
state: New York
city: Charlotte
country: United States
facility: Atrium Healthcare
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Portland
country: United States
facility: Oregon Rural Practice-based Research Network (ORPRN)
state: Oregon
Study officials:
affiliation: Weill Medical College of Cornell University
name: Fernando J Martinez, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: MeiLan Han, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.