Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Comparative Effectiveness of COPD Assessment and Management Bundle Versus Usual Care in Patients Suspected of Having COPD
Verified date | December 2019 |
Source | University of Illinois at Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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 1. 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 2. 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. 3. 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. 4. 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 5. 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: 1. Unable to perform adequate spirometry (e.g. muscle weakness, tracheostomy, cognitive dysfunction, mental retardation or other psychiatric disorders) 2. Non-English speaking 3. Pregnancy 4. Any patient planning to move away from the city within the next year. 5. Seen by a pulmonary specialist in the past 3 years. 6. Any terminal illness with a life expectancy of <6 months (e.g. hospice care, malignancies) 7. Any patient with a physician diagnosis of COPD and had a pre or post-bronchodilator spirometry with evidence of chronic obstruction on record. |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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. — View Citation
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. — View Citation
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. Epub 2004 Nov 11. — View Citation
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. — View Citation
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. — View Citation
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
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. — View Citation
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. Epub 2007 Mar 30. — View Citation
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. Epub 2007 Jun 5. — View Citation
Holleman DR Jr, Simel DL. Does the clinical examination predict airflow limitation? JAMA. 1995 Jan 25;273(4):313-9. Erratum in: JAMA 1995 May 3;273(17):1334. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2006 Oct 19. — View Citation
Lee TA, Bartle B, Weiss KB. Spirometry use in clinical practice following diagnosis of COPD. Chest. 2006 Jun;129(6):1509-15. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Morbidity and mortality: 2009 chartbook on cardiovascular, lung and blood diseases: National Heart Lung and Blood Institute, 2009
Pauwels RA, Buist AS, Ma P, Jenkins CR, Hurd SS; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: National Heart, Lung, and Blood Institute and World Health Organization Global Initiative for Chronic Obstructive Lung Disease (GOLD): executive summary. Respir Care. 2001 Aug;46(8):798-825. Review. — View Citation
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. — View Citation
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. Review. Erratum in: JAMA. 2009 Mar 25;301(12):1227-30. — View Citation
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. Erratum in: JAMA 2000 Jul 12;284(2):181. — View Citation
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. — View Citation
Sullivan SD, Ramsey SD, Lee TA. The economic burden of COPD. Chest. 2000 Feb;117(2 Suppl):5S-9S. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2006 Jul 26. — View Citation
* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 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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