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

Study Overview
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Brief Summary
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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
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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. 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.

Official Title
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The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Other: COPD plus CAPTURE education and patient-level information
* Other: COPD Education Only


Participation Criteria
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Eligibility Criteria
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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 Chest surgery Abdominal surgery Eye surgery Heart attack Stroke

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAPTURE + COPD Education<br>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<br>* 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.<br>|
| Active Comparator: COPD Education<br>Practice clinicians will receive basic COPD education only. | Other: COPD Education Only<br>* Practice clinicians will receive basic COPD education only. Patient-level CAPTURE information will not be provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of CAPTURE+ participants who are referred for or complete clinical spirometry testing | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants who are newly diagnosed with COPD | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants with newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants referred 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants who are referred for or complete 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants who have received a recommendation for, or administration of influenza vaccination. | 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. | Baseline to 12 months | 
| 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. | Proportion of CAPTURE+ participants currently smoking at the baseline study visit who have any of the components of the Aim 3 primary 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. OR 1) clinical counseling or recommendation for smoking cessation, 2) referral to a smoking cessation program, 3) referral to a smoking quit line, 4) newly prescribed medication for smoking cessation. 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants currently smoking at baseline who are referred for or complete clinical spirometry testing | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants currently smoking at baseline who receive a new diagnosis of COPD | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants currently smoking at baseline who are newly prescribed respiratory medication | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants currently smoking at baseline who receive a 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants currently smoking at baseline who receive a referral for, or complete 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants currently smoking at baseline who receive clinician counseling or recommendation for smoking cessation | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants currently smoking at baseline who receive a referral to a smoking cessation program | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants currently smoking at baseline who referral to a smoking quit line | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants currently smoking at baseline who receive a newly prescribed medication for smoking cessation. | 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. | Baseline to 12 months | 
| Change in COPD Assessment Test (CAT) score in CAPTURE+ participants | 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. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants who experience exacerbations, hospitalizations, or mortality | 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. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD who meet any of the components of the primary endpoint. | Proportion of participants with clinically significant 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), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. (composite endpoint) Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD with a referral for or completion of clinical spirometry testing | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD with a new diagnosis of COPD | COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD with a newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD with a referral to a specialist for respiratory evaluation/treatment | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD with a referral for or completion of pulmonary rehabilitation. | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD who receive a recommendation for or administration of influenza vaccination | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD who meet any of the components of the primary endpoint. | Proportion of participants with spirometric 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), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD referred for or completion of clinical spirometry testing | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD with a new diagnosis of COPD. | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD with newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD referred to a specialist for respiratory evaluation/treatment | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD who are referred for or complete pulmonary rehabilitation. | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD who receive a recommendation for or administration of influenza vaccination. | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with Mild COPD who meet any of the components of the primary endpoint | Proportion of participants with Mild 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), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD referred for or completion of clinical spirometry testing | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD with a new diagnosis of COPD | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD with a newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD referred to a specialist for respiratory evaluation/treatment | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD referred for or completion of pulmonary rehabilitation. | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD who received a recommendation or administration of influenza vaccination. | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, imparied spirometry (PRISm) who meet any of the components of the primary endpoint. | Proportion of participants with preserved ratio, impaired spirometry (PRISm) 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. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) referred for or completion of clinical spirometry testing. | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) with new diagnosis of COPD. | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) with a newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) referred to a specialist for respiratory evaluation/treatment | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) referred for or completion of pulmonary rehabilitation. | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) who receive a recommendation for or administration of influenza vaccination. | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) meet any of the components of the primary endpoint. | Proportion of participants with symptomatic non-obstructed (SNO) 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. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) referred for or completion of clinical spirometry testing. | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) with a new diagnosis of COPD | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) referred to a specialist for respiratory evaluation/treatment | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) referred for or completion of pulmonary rehabilitation. | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) who receive a recommendation or administration of influenza vaccination. | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled before March 18, 2020 who meet any of the components of the primary endpoint. | Proportion of CAPTURE+ participants enrolled before March 18, 2020 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled after August 13, 2020 who meet any of the components of the primary endpoint. | Proportion of CAPTURE+ participants enrolled after August 13, 2020 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled before March 18, 2020 who are referred for or complete clinical spirometry testing | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled after August 13, 2020 who are referred for or complete clinical spirometry testing | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled before March 18, 2020 who are newly diagnosed with COPD | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled after August 13, 2020 who are newly diagnosed with COPD | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled before March 18, 2020 with newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled after August 13, 2020 with newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled before March 18, 2020 referred 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled after August 13, 2020 referred 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled before March 18, 2020 who are referred for or complete 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled after August 13, 2020 who are referred for or complete 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled before March 18, 2020 who have received a recommendation for, or administration of influenza vaccination | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled after August 13, 2020 who have received a recommendation for, or administration of influenza vaccination | 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants currently smoking at baseline who have received a recommendation for, or administration of influenza vaccination | 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. | Baseline to 12 months | 
| Change in COPD Assessment Test (CAT) score in CAPTURE+ participants enrolled before March 18, 2020 | 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. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. | Baseline to 12 months | 
| Change in COPD Assessment Test (CAT) score in CAPTURE+ participants enrolled after August 13, 2020 | 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. The COPD Assessment Test (CAT) is an 8-item questionnaire that measures the impact of COPD on a person's life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled before March 18, 2020 who experience exacerbations, hospitalizations, or mortality | Composite endpoint 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. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants enrolled after August 13, 2020 who experience exacerbations, hospitalizations, or mortality | Composite endpoint 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. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled before March 18, 2020 who meet any of components of the primary endpoints. | Proportion of participants with clinically significant COPD enrolled before March 18, 2020 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. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled after August 13, 2020 who meet any of components of the primary endpoints. | Proportion of participants with clinically significant COPD enrolled after August 13, 2020 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. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled before March 18, 2020 with a referral for or completion of clinical spirometry testing | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled after August 13, 2020 with a referral for or completion of clinical spirometry testing | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled before March 18, 2020 with a new diagnosis of COPD | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled after August 13, 2020 a new diagnosis of COPD | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled before March 18, 2020 with a newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled after August 13, 2020 with a newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled before March 18, 2020 with a referral to a specialist for respiratory evaluation/treatment | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled after August 13, 2020 with a referral to a specialist for respiratory evaluation/treatment | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled before March 18, 2020 with a referral for or completion of pulmonary rehabilitation | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled after August 13, 2020 with a referral for or completion of pulmonary rehabilitation | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled before March 18, 2020 who receive a recommendation for or administration of influenza vaccination | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with clinically significant COPD enrolled after August 13, 2020 who receive a recommendation for or administration of influenza vaccination | Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7, plus one of the following: 1) FEV1 < 60% predicted or > 1 exacerbation like event within the past 12 months. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled before March 18, 2020 who meet any of the components of the primary endpoint | Proportion of participants with spirometric COPD enrolled before March 18, 2020 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 Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled after August 13, 2020 who meet any of the components of the primary endpoint | Proportion of participants with spirometric COPD enrolled after August 13, 2020 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 Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled before March 18, 2020 referred for or completion of clinical spirometry testing | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled after August 13, 2020 referred for or completion of clinical spirometry testing | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled before March 18, 2020 with a new diagnosis of COPD | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled after August 13, 2020 with a new diagnosis of COPD | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled before March 18, 2020 with newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled after August 13, 2020 with newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled before March 18, 2020 referred to a specialist for respiratory evaluation/treatment | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled after August 13, 2020 referred to a specialist for respiratory evaluation/treatment | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled before March 18, 2020 who are referred for or complete pulmonary rehabilitation | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled after August 13, 2020 who are referred for or complete pulmonary rehabilitation | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled before March 18, 2020 who receive a recommendation for or administration of influenza vaccination | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with spirometric COPD enrolled after August 13, 2020 who receive a recommendation for or administration of influenza vaccination | Spirometric COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC <0.7. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled before March 18, 2020 who meet any of the components of the primary endpoint | Proportion of participants with mild COPD enrolled before March 18, 2020 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. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled after August 13, 2020 who meet any of the components of the primary endpoint | Proportion of participants with mild COPD enrolled after August 13, 2020 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. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled before March 18, 2020 referred for or completion of clinical spirometry testing | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled after August 13, 2020 referred for or completion of clinical spirometry testing | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled before March 18, 2020 with a new diagnosis of COPD | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled after August 13, 2020 with a new diagnosis of COPD | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled before March 18, 2020 with a newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled after August 13, 2020 with a newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled before March 18, 2020 referred to a specialist for respiratory evaluation/treatment | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled after August 13, 2020 referred to a specialist for respiratory evaluation/treatment | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled before March 18, 2020 referred for or completion of pulmonary rehabilitation | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled after August 13, 2020 referred for or completion of pulmonary rehabilitation | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled before March 18, 2020 who received a recommendation or administration of influenza vaccination | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with mild COPD enrolled after August 13, 2020 who received a recommendation or administration of influenza vaccination | Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC<0.7 plus both of the following: 1) FEV1 ≥ 60% and 2) No prior history of exacerbation of COPD. | Baseline to 12 months | 
| Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled before March 18, 2020 who meet any of the components of the primary endpoint. | Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled before March 18, 2020 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. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled after August 13, 2020 who meet any of the components of the primary endpoint. | Proportion of participants with preserved ration, impaired spirometry (PRISm) enrolled after August 13, 2020 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. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled before March 18, 2020 referred for or completion of clinical spirometry testing | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled after August 13, 2020 referred for or completion of clinical spirometry testing | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled before March 18, 2020 with new diagnosis of COPD | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled after August 13, 2020 with new diagnosis of COPD | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled before March 18, 2020 with a newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled after August 18, 2020 with a newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled before March 18, 2020 referred to a specialist for respiratory evaluation/treatment | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled after August 13, 2020 referred to a specialist for respiratory evaluation/treatment | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled before March 18, 2020 referred for or completion of pulmonary rehabilitation | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled after August 13, 2020 referred for or completion of pulmonary rehabilitation | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled before March 18, 2020 who receive a recommendation for or administration of influenza vaccination | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with preserved ratio, impaired spirometry (PRISm) enrolled after August 13, 2020 who receive a recommendation for or administration of influenza vaccination | Preserved ratio, impaired spirometry (PRISm) is defined as participants without spirometrically defined COPD who have post-bronchodilator FEV1 < 80% predicted. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 who meet any of the components of the primary endpoint. | Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 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. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 who meet any of the components of the primary endpoint. | Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 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. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 referred for or completion of clinical spirometry testing | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 referred for or completion of clinical spirometry testing | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 with a new diagnosis of COPD | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 with a new diagnosis of COPD | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 newly prescribed respiratory medication | Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition. Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 referred to a specialist for respiratory evaluation/treatment | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 referred to a specialist for respiratory evaluation/treatment | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 referred for or completion of pulmonary rehabilitation | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 referred for or completion of pulmonary rehabilitation | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled before March 18, 2020 who receive a recommendation or administration of influenza vaccination. | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of participants with symptomatic non-obstructed (SNO) enrolled after August 13, 2020 who receive a recommendation or administration of influenza vaccination. | Symptomatic non-obstructed (SNO) is defined as participants without spirometrically defined COPD and without PRISm who have a COPD Assessment Test score ≥ 10. | Baseline to 12 months | 
| Proportion of CAPTURE+ participants currently smoking at baseline who received over-the-counter patches/gum for smoking cessation |  | Baseline to 12 months |