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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL094461 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory (lung) disease that makes it harder to breathe over time. To date, there is no cure for COPD, but it can be managed when diagnosed and proper medical care is provided.
The purpose of this study is to determine if diagnosis and guided therapy with the use of spirometry is related to better patient outcomes (the condition of a patient's health) compared to usual care which may or may not include the use of spirometry. Spirometry is a standardized test used in medical practice that measures how much air your lungs can hold and how forcefully you can breathe out.
For this study, the investigators will compare two groups: 1) intervention (treatment) group and 2) usual care group (control). The intervention group will have a spirometry test and the results will be provided to the primary care physician. The usual care group will not initially have a spirometry test. Both groups will be followed for outcomes.
The purpose of this study is to determine if diagnosis and guided therapy with the use of spirometry is related to better patient associated outcomes compared to usual care which may or may not include the use of spirometry. To do this, we propose a comparative effectiveness trial of introducing a COPD assessment and management bundle targeted to primary care providers for patients suspected of having COPD versus usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD assessment and management recommendations | Experimental | Patients with a physician-diagnosed COPD or asthma suspicious for COPD being managed by the physician randomized to the intervention group will perform a spirometry test and provide information regarding their medical history on their initial visit, which is 90 minutes before their doctor's appointment. A letter containing the interpretation of spirometry test results, and recommendations for guideline based therapy based on GOLD guidelines will be available to the primary care doctor at the time of the patient's clinic visit. The doctor may review the results and use his or her own judgment in moving forward with the subject's diagnosis and management. A copy of the spirometry results and assessment based on the GOLD criteria at the time of the test of your subject will be uploaded to his or her electronic health record for future reference. Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. |
|
| Usual Care | Placebo Comparator | Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care. Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spirometry test | Device | For the initial visit for the intervention group, an initial demographics form and a health questionnaire will given to the subject to complete. To evaluate the breathing and quality of living, a spirometry test will be performed that will evaluate how well and how fast the subject can breath and blow out air. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Accurate Classification of Irreversible Airflow Obstruction | accuracy of diagnosis was the outcome measure. The results of the spirometry test (done in the beginning for the intervention group and ant the end of 1 year for the usual care groups) were reviewed in conjunction with the initial physician diagnosis of COPD and/or asthma to confirm whether the diagnosis was accurate, not accurate, or indeterminate. Accuracy of diagnosis of COPD was determined by spirometry results if the FEV1/FVC ratio was <0.7. | spirometry was performed at the first visit for intervention group and at 1 year from recruitment for the usual care group, one time assessment for both groups |
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Inclusion Criteria:
Patients, male and female, who are at least 40 years of age, receive primary treatment at the University of Illinois , and with any one of the following:
New Diagnosis
Inpatient or emergency department setting
New physician-diagnosis of COPD and/or new physician-diagnosis of asthma with a ≥10 pack year smoking without a spirometry 4 weeks or more after discharge from diagnosis setting.
Outpatient setting
A new physician diagnosis of COPD within the past 6 months prior to their visit, without a spirometry or with a normal spirometry within the past 5 years prior to the diagnosis to the time of their visit.
A new physician diagnosis of asthma within past 6 months and a ≥10 pack year smoking history prior to their visit, without a diagnosis of COPD, without a spirometry or with a pre-bronchodilator spirometry with evidence of obstruction within the past 5 years prior to the diagnosis to the time of their visit.
Any patient with an existing physician-diagnosis of asthma within the past 2 years but > 6 months prior to the time of their visit and a ≥10 pack year smoking history, without a diagnosis of COPD, using a respiratory medication in the past year, and no spirometry on record or had a pre-bronchodilator spirometry with evidence of obstruction on record for at least the past 5 years.
Existing Diagnosis
Any patient with an existing physician-diagnosis of COPD within the past 2 years but > 6 months prior to the time of their visit, and using a respiratory medication in the past year but no spirometry on record or had a spirometry without evidence of chronic obstruction in the past 5 years.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Joo, MD, MPH | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease: World Health Organization and National Heart, Lung, and Blood Institute, 2011 | ||
| 22142836 | Background | Akinbami LJ, Liu X. Chronic obstructive pulmonary disease among adults aged 18 and over in the United States, 1998-2009. NCHS Data Brief. 2011 Jun;(63):1-8. | |
| 10673466 |
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None to report
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care. Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference. |
| FG001 | Intervention | Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care. Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference. Spirometry test: For the initial visit for the intervention group, an initial demographics form and a health questionnaire will given to the subject to complete. To evaluate the breathing and quality of living, a spirometry test |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | COPD Assessment and Management Recommendations | Patients with a physician-diagnosed COPD or asthma suspicious for COPD being managed by the physician randomized to the intervention group will perform a spirometry test and provide information regarding their medical history on their initial visit, which is 90 minutes before their doctor's appointment. A letter containing the interpretation of spirometry test results, and recommendations for guideline based therapy based on GOLD guidelines will be available to the primary care doctor at the time of the patient's clinic visit. The doctor may review the results and use his or her own judgment in moving forward with the subject's diagnosis and management. A copy of the spirometry results and assessment based on the GOLD criteria at the time of the test of your subject will be uploaded to his or her electronic health record for future reference. Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Accurate Classification of Irreversible Airflow Obstruction | accuracy of diagnosis was the outcome measure. The results of the spirometry test (done in the beginning for the intervention group and ant the end of 1 year for the usual care groups) were reviewed in conjunction with the initial physician diagnosis of COPD and/or asthma to confirm whether the diagnosis was accurate, not accurate, or indeterminate. Accuracy of diagnosis of COPD was determined by spirometry results if the FEV1/FVC ratio was <0.7. | Posted | Count of Participants | Participants | spirometry was performed at the first visit for intervention group and at 1 year from recruitment for the usual care group, one time assessment for both groups |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COPD Assessment and Management Recommendations | Patients with a physician-diagnosed COPD or asthma suspicious for COPD being managed by the physician randomized to the intervention group will perform a spirometry test and provide information regarding their medical history on their initial visit, which is 90 minutes before their doctor's appointment. A letter containing the interpretation of spirometry test results, and recommendations for guideline based therapy based on GOLD guidelines will be available to the primary care doctor at the time of the patient's clinic visit. The doctor may review the results and use his or her own judgment in moving forward with the subject's diagnosis and management. A copy of the spirometry results and assessment based on the GOLD criteria at the time of the test of your subject will be uploaded to his or her electronic health record for future reference. Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Min Joo | University of Illinois at Chicago | 3129968039 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D013147 | Spirometry |
| D064412 | Levalbuterol |
| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
|
| Levalbuterol | Drug | The spirometry test will be performed with a breathing medication called Levalbuterol (Xopenex®). Levalbuterol is used in standard practice for COPD and is commonly used during spirometry. |
|
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| Background |
| Sullivan SD, Ramsey SD, Lee TA. The economic burden of COPD. Chest. 2000 Feb;117(2 Suppl):5S-9S. doi: 10.1378/chest.117.2_suppl.5s. |
| 10999980 | Background | Mapel DW, Hurley JS, Frost FJ, Petersen HV, Picchi MA, Coultas DB. Health care utilization in chronic obstructive pulmonary disease. A case-control study in a health maintenance organization. Arch Intern Med. 2000 Sep 25;160(17):2653-8. doi: 10.1001/archinte.160.17.2653. |
| Background | Chronic obstructive pulmonary disease data fact sheet: U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, 2003 |
| Background | Morbidity and mortality: 2009 chartbook on cardiovascular, lung and blood diseases: National Heart Lung and Blood Institute, 2009 |
| 17550936 | Background | Han MK, Kim MG, Mardon R, Renner P, Sullivan S, Diette GB, Martinez FJ. Spirometry utilization for COPD: how do we measure up? Chest. 2007 Aug;132(2):403-9. doi: 10.1378/chest.06-2846. Epub 2007 Jun 5. |
| 18347201 | Background | Joo MJ, Lee TA, Weiss KB. Geographic variation of spirometry use in newly diagnosed COPD. Chest. 2008 Jul;134(1):38-45. doi: 10.1378/chest.08-0013. Epub 2008 Mar 17. |
| 16778268 | Background | Lee TA, Bartle B, Weiss KB. Spirometry use in clinical practice following diagnosis of COPD. Chest. 2006 Jun;129(6):1509-15. doi: 10.1378/chest.129.6.1509. |
| 17005056 | Background | Damarla M, Celli BR, Mullerova HX, Pinto-Plata VM. Discrepancy in the use of confirmatory tests in patients hospitalized with the diagnosis of chronic obstructive pulmonary disease or congestive heart failure. Respir Care. 2006 Oct;51(10):1120-4. |
| 21713542 | Background | Joo MJ, Au DH, Fitzgibbon ML, McKell J, Lee TA. Determinants of spirometry use and accuracy of COPD diagnosis in primary care. J Gen Intern Med. 2011 Nov;26(11):1272-7. doi: 10.1007/s11606-011-1770-1. Epub 2011 Jun 29. |
| 7956395 | Background | Badgett RG, Tanaka DJ, Hunt DK, Jelley MJ, Feinberg LE, Steiner JF, Petty TL. The clinical evaluation for diagnosing obstructive airways disease in high-risk patients. Chest. 1994 Nov;106(5):1427-31. doi: 10.1378/chest.106.5.1427. |
| 15078751 | Background | Buffels J, Degryse J, Heyrman J, Decramer M; DIDASCO Study. Office spirometry significantly improves early detection of COPD in general practice: the DIDASCO Study. Chest. 2004 Apr;125(4):1394-9. doi: 10.1378/chest.125.4.1394. |
| 12220364 | Background | Straus SE, McAlister FA, Sackett DL, Deeks JJ; CARE-COAD2 Group. Clinical Assessment of the Reliability of the Examination-Chronic Obstructive Airways Disease. Accuracy of history, wheezing, and forced expiratory time in the diagnosis of chronic obstructive pulmonary disease. J Gen Intern Med. 2002 Sep;17(9):684-8. doi: 10.1046/j.1525-1497.2002.20102.x. |
| 1792447 | Background | van Schayck CP, van Weel C, Harbers HJ, van Herwaarden CL. Do physical signs reflect the degree of airflow obstruction in patients with asthma or chronic obstructive pulmonary disease? Scand J Prim Health Care. 1991 Dec;9(4):232-8. doi: 10.3109/02813439109018525. |
| 10770147 | Background | Straus SE, McAlister FA, Sackett DL, Deeks JJ. The accuracy of patient history, wheezing, and laryngeal measurements in diagnosing obstructive airway disease. CARE-COAD1 Group. Clinical Assessment of the Reliability of the Examination-Chronic Obstructive Airways Disease. JAMA. 2000 Apr 12;283(14):1853-7. doi: 10.1001/jama.283.14.1853. |
| 7815660 | Background | Holleman DR Jr, Simel DL. Does the clinical examination predict airflow limitation? JAMA. 1995 Jan 25;273(4):313-9. No abstract available. |
| 15763457 | Background | Bolton CE, Ionescu AA, Edwards PH, Faulkner TA, Edwards SM, Shale DJ. Attaining a correct diagnosis of COPD in general practice. Respir Med. 2005 Apr;99(4):493-500. doi: 10.1016/j.rmed.2004.09.015. Epub 2004 Nov 11. |
| 12198919 | Background | Mannino DM, Homa DM, Akinbami LJ, Ford ES, Redd SC. Chronic obstructive pulmonary disease surveillance--United States, 1971-2000. MMWR Surveill Summ. 2002 Aug 2;51(6):1-16. |
| 10847262 | Background | Mannino DM, Gagnon RC, Petty TL, Lydick E. Obstructive lung disease and low lung function in adults in the United States: data from the National Health and Nutrition Examination Survey, 1988-1994. Arch Intern Med. 2000 Jun 12;160(11):1683-9. doi: 10.1001/archinte.160.11.1683. |
| 16448970 | Background | Tinkelman DG, Price DB, Nordyke RJ, Halbert RJ. Misdiagnosis of COPD and asthma in primary care patients 40 years of age and over. J Asthma. 2006 Jan-Feb;43(1):75-80. doi: 10.1080/02770900500448738. |
| 16870668 | Background | Walker PP, Mitchell P, Diamantea F, Warburton CJ, Davies L. Effect of primary-care spirometry on the diagnosis and management of COPD. Eur Respir J. 2006 Nov;28(5):945-52. doi: 10.1183/09031936.06.00019306. Epub 2006 Jul 26. |
| 21345188 | Background | Mapel DW, Dutro MP, Marton JP, Woodruff K, Make B. Identifying and characterizing COPD patients in US managed care. A retrospective, cross-sectional analysis of administrative claims data. BMC Health Serv Res. 2011 Feb 23;11:43. doi: 10.1186/1472-6963-11-43. |
| 22695054 | Background | Schnell K, Weiss CO, Lee T, Krishnan JA, Leff B, Wolff JL, Boyd C. The prevalence of clinically-relevant comorbid conditions in patients with physician-diagnosed COPD: a cross-sectional study using data from NHANES 1999-2008. BMC Pulm Med. 2012 Jul 9;12:26. doi: 10.1186/1471-2466-12-26. |
| 17314337 | Background | Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J; TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007 Feb 22;356(8):775-89. doi: 10.1056/NEJMoa063070. |
| 17400730 | Background | Ernst P, Gonzalez AV, Brassard P, Suissa S. Inhaled corticosteroid use in chronic obstructive pulmonary disease and the risk of hospitalization for pneumonia. Am J Respir Crit Care Med. 2007 Jul 15;176(2):162-6. doi: 10.1164/rccm.200611-1630OC. Epub 2007 Mar 30. |
| 17053207 | Background | Kardos P, Wencker M, Glaab T, Vogelmeier C. Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2007 Jan 15;175(2):144-9. doi: 10.1164/rccm.200602-244OC. Epub 2006 Oct 19. |
| 18794557 | Background | Lee TA, Pickard AS, Au DH, Bartle B, Weiss KB. Risk for death associated with medications for recently diagnosed chronic obstructive pulmonary disease. Ann Intern Med. 2008 Sep 16;149(6):380-90. doi: 10.7326/0003-4819-149-6-200809160-00004. |
| 18812535 | Background | Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAMA. 2008 Sep 24;300(12):1439-50. doi: 10.1001/jama.300.12.1439. |
| BG001 | Usual Care | Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care. Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Care | Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care. Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference. |
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Usual Care | Patients with a physician-diagnosed COPD or physician-diagnosed asthma suspicious for COPD being managed by the physician randomized to the usual care group will provide medical history, not initially have a spirometry, and will be observed as usual care. Outcomes will be assessed every 3 months for up to one year through patient telephone calls and medical chart reviews. At the conclusion of the research study which will be 12 months from the patients' initial visit, patients being managed by the physician randomized to the usual care group will have a spirometry test and these results will not be shared with the doctor or the patients during the study but will be uploaded to the electronic health record after the end of the study for future reference. | 0 | 22 | 0 | 22 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |