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Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study

Primary Purpose

Emphysema, Chronic Obstructive Pulmonary Disease

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Emphasys Endobronchial Valve (EBV) Device and Procedure
Sponsored by
Emphasys Medical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema focused on measuring Endobronchial Valve, Endobronchial Valve ProcedureEBV, EBV Procedure, Endobronchial Lung Volume Reduction, Lung Volume Reduction

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed by high-resolution computed tomography (HRCT) with eligible heterogeneous disease distribution Forced expiratory volume in 1 second (FEV1) < 45% predicted Total lung capacity (TLC) > 100% predicted Residual volume (RV) > 150% predicted Post rehabilitation 6 minute walk test > 140m Non-smoking for 4 months Exclusion Criteria: Prior lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy or lobectomy History of recurrent respiratory infections Evidence of large bullae (> 30% of either lung) in a non-target lobe FEV1 < 15% predicted Diffusing capacity of the lung for carbon monoxide (DLCO) < 20% predicted

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The cost-effectiveness ratio in the treatment group as compared to the control group at 180 days

    Secondary Outcome Measures

    The cost-effectiveness ratio in the treatment group of the study will be compared to established therapies and standards.

    Full Information

    First Posted
    August 26, 2005
    Last Updated
    August 14, 2009
    Sponsor
    Emphasys Medical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00137956
    Brief Title
    Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study
    Official Title
    Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2009
    Overall Recruitment Status
    Terminated
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Emphasys Medical

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the VENT Cost-Effectiveness Sub-Study is to gather healthcare utilization and quality of life information on patients enrolled in the VENT study in order to analyze the relative cost-effectiveness of the endobronchial valve implant procedure.
    Detailed Description
    Therapeutic interventions in health care require the use of resources. Since these resources are limited, it is important for clinical decision-makers to have economic information in addition to safety and efficacy data. In the economic environment of health care today, the incremental costs for a new therapeutic intervention must be offset by the value associated with better outcomes such as improved health and health-related quality of life and/or lower health care utilization costs over time. Questions about the cost and effectiveness of medical care have generated considerable attention in medical outcomes research. In 1993, the Department of Health and Human Services appointed a multi-disciplinary group to recommend standards for the evaluation of health care. The panel's report suggested that standardized outcomes analyses be conducted to evaluate the cost-effectiveness of medical care. These analyses require preference-weighted measures of health-related quality of life. Such measures are needed in order to adjust survival time for health-related quality of life.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Emphysema, Chronic Obstructive Pulmonary Disease
    Keywords
    Endobronchial Valve, Endobronchial Valve ProcedureEBV, EBV Procedure, Endobronchial Lung Volume Reduction, Lung Volume Reduction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    270 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Emphasys Endobronchial Valve (EBV) Device and Procedure
    Primary Outcome Measure Information:
    Title
    The cost-effectiveness ratio in the treatment group as compared to the control group at 180 days
    Secondary Outcome Measure Information:
    Title
    The cost-effectiveness ratio in the treatment group of the study will be compared to established therapies and standards.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed by high-resolution computed tomography (HRCT) with eligible heterogeneous disease distribution Forced expiratory volume in 1 second (FEV1) < 45% predicted Total lung capacity (TLC) > 100% predicted Residual volume (RV) > 150% predicted Post rehabilitation 6 minute walk test > 140m Non-smoking for 4 months Exclusion Criteria: Prior lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy or lobectomy History of recurrent respiratory infections Evidence of large bullae (> 30% of either lung) in a non-target lobe FEV1 < 15% predicted Diffusing capacity of the lung for carbon monoxide (DLCO) < 20% predicted
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Kaplan, PhD
    Organizational Affiliation
    UCLA School of Public Health, UCSD Health Outcomes Assessment Program (HOAP)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    8632690
    Citation
    Gold M, Franks P, Erickson P. Assessing the health of the nation. The predictive validity of a preference-based measure and self-rated health. Med Care. 1996 Feb;34(2):163-77. doi: 10.1097/00005650-199602000-00008.
    Results Reference
    background
    PubMed Identifier
    10155335
    Citation
    Feeny D, Furlong W, Boyle M, Torrance GW. Multi-attribute health status classification systems. Health Utilities Index. Pharmacoeconomics. 1995 Jun;7(6):490-502. doi: 10.2165/00019053-199507060-00004.
    Results Reference
    background
    PubMed Identifier
    11151395
    Citation
    Hays RD, Woolley JM. The concept of clinically meaningful difference in health-related quality-of-life research. How meaningful is it? Pharmacoeconomics. 2000 Nov;18(5):419-23. doi: 10.2165/00019053-200018050-00001.
    Results Reference
    background
    PubMed Identifier
    10155336
    Citation
    Torrance GW, Furlong W, Feeny D, Boyle M. Multi-attribute preference functions. Health Utilities Index. Pharmacoeconomics. 1995 Jun;7(6):503-20. doi: 10.2165/00019053-199507060-00005.
    Results Reference
    background
    PubMed Identifier
    9817107
    Citation
    Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol. 1998 Nov;51(11):903-12. doi: 10.1016/s0895-4356(98)00081-x.
    Results Reference
    background
    PubMed Identifier
    11269488
    Citation
    Ramsey SD, Sullivan SD, Kaplan RM, Wood DE, Chiang YP, Wagner JL. Economic analysis of lung volume reduction surgery as part of the National Emphysema Treatment Trial. NETT Research Group. Ann Thorac Surg. 2001 Mar;71(3):995-1002. doi: 10.1016/s0003-4975(00)02283-9.
    Results Reference
    background
    PubMed Identifier
    12759480
    Citation
    Ramsey SD, Berry K, Etzioni R, Kaplan RM, Sullivan SD, Wood DE; National Emphysema Treatment Trial Research Group. Cost effectiveness of lung-volume-reduction surgery for patients with severe emphysema. N Engl J Med. 2003 May 22;348(21):2092-102. doi: 10.1056/NEJMsa030448. Epub 2003 May 20.
    Results Reference
    background
    PubMed Identifier
    12941712
    Citation
    Diabetes Prevention Program Research Group. Within-trial cost-effectiveness of lifestyle intervention or metformin for the primary prevention of type 2 diabetes. Diabetes Care. 2003 Sep;26(9):2518-23. doi: 10.2337/diacare.26.9.2518.
    Results Reference
    background
    PubMed Identifier
    7934274
    Citation
    Kaplan RM. Value judgment in the Oregon Medicaid experiment. Med Care. 1994 Oct;32(10):975-88. doi: 10.1097/00005650-199410000-00001.
    Results Reference
    background
    PubMed Identifier
    10971663
    Citation
    Sieber WJ, David KM, Adams JE, Kaplan RM, Ganiats TG. Assessing the impact of migraine on health-related quality of life: An additional use of the quality of well-being scale-self-administered. Headache. 2000 Sep;40(8):662-71. doi: 10.1046/j.1526-4610.2000.040008662.x.
    Results Reference
    background
    PubMed Identifier
    6420431
    Citation
    Kaplan RM, Atkins CJ, Timms R. Validity of a quality of well-being scale as an outcome measure in chronic obstructive pulmonary disease. J Chronic Dis. 1984;37(2):85-95. doi: 10.1016/0021-9681(84)90050-x.
    Results Reference
    background
    PubMed Identifier
    7792372
    Citation
    Kaplan RM, Anderson JP, Patterson TL, McCutchan JA, Weinrich JD, Heaton RK, Atkinson JH, Thal L, Chandler J, Grant I. Validity of the Quality of Well-Being Scale for persons with human immunodeficiency virus infection. HNRC Group. HIV Neurobehavioral Research Center. Psychosom Med. 1995 Mar-Apr;57(2):138-47. doi: 10.1097/00006842-199503000-00006.
    Results Reference
    background
    PubMed Identifier
    1914549
    Citation
    Orenstein DM, Kaplan RM. Measuring the quality of well-being in cystic fibrosis and lung transplantation. The importance of the area under the curve. Chest. 1991 Oct;100(4):1016-8. doi: 10.1378/chest.100.4.1016.
    Results Reference
    background
    PubMed Identifier
    2225948
    Citation
    Orenstein DM, Pattishall EN, Nixon PA, Ross EA, Kaplan RM. Quality of well-being before and after antibiotic treatment of pulmonary exacerbation in patients with cystic fibrosis. Chest. 1990 Nov;98(5):1081-4. doi: 10.1378/chest.98.5.1081.
    Results Reference
    background
    PubMed Identifier
    3302144
    Citation
    Kaplan RM, Hartwell SL, Wilson DK, Wallace JP. Effects of diet and exercise interventions on control and quality of life in non-insulin-dependent diabetes mellitus. J Gen Intern Med. 1987 Jul-Aug;2(4):220-8. doi: 10.1007/BF02596443.
    Results Reference
    background
    PubMed Identifier
    1405801
    Citation
    Ganiats TG, Palinkas LA, Kaplan RM. Comparison of Quality of Well-Being scale and Functional Status Index in patients with atrial fibrillation. Med Care. 1992 Oct;30(10):958-64. doi: 10.1097/00005650-199210000-00008. No abstract available.
    Results Reference
    background
    PubMed Identifier
    8520772
    Citation
    Squier HC, Ries AL, Kaplan RM, Prewitt LM, Smith CM, Kriett JM, Jamieson SW. Quality of well-being predicts survival in lung transplantation candidates. Am J Respir Crit Care Med. 1995 Dec;152(6 Pt 1):2032-6. doi: 10.1164/ajrccm.152.6.8520772.
    Results Reference
    background
    PubMed Identifier
    3532786
    Citation
    Bombardier C, Ware J, Russell IJ, Larson M, Chalmers A, Read JL. Auranofin therapy and quality of life in patients with rheumatoid arthritis. Results of a multicenter trial. Am J Med. 1986 Oct;81(4):565-78. doi: 10.1016/0002-9343(86)90539-5.
    Results Reference
    background
    PubMed Identifier
    7679324
    Citation
    Kaplan RM. Quality of life assessment for cost/utility studies in cancer. Cancer Treat Rev. 1993;19 Suppl A:85-96. doi: 10.1016/0305-7372(93)90061-u.
    Results Reference
    background
    PubMed Identifier
    9327227
    Citation
    Kaplan RM. Decisions about prostate cancer screening in managed care. Curr Opin Oncol. 1997 Sep;9(5):480-6. doi: 10.1097/00001622-199709050-00014.
    Results Reference
    background
    PubMed Identifier
    8878313
    Citation
    Patterson TL, Kaplan RM, Grant I, Semple SJ, Moscona S, Koch WL, Harris MJ, Jeste DV. Quality of well-being in late-life psychosis. Psychiatry Res. 1996 Jul 31;63(2-3):169-81. doi: 10.1016/0165-1781(96)02797-7.
    Results Reference
    background
    PubMed Identifier
    8849754
    Citation
    Weinstein MC, Siegel JE, Gold MR, Kamlet MS, Russell LB. Recommendations of the Panel on Cost-effectiveness in Health and Medicine. JAMA. 1996 Oct 16;276(15):1253-8.
    Results Reference
    background
    PubMed Identifier
    8827972
    Citation
    Russell LB, Gold MR, Siegel JE, Daniels N, Weinstein MC. The role of cost-effectiveness analysis in health and medicine. Panel on Cost-Effectiveness in Health and Medicine. JAMA. 1996 Oct 9;276(14):1172-7.
    Results Reference
    background
    PubMed Identifier
    402576
    Citation
    Weinstein MC, Stason WB. Foundations of cost-effectiveness analysis for health and medical practices. N Engl J Med. 1977 Mar 31;296(13):716-21. doi: 10.1056/NEJM197703312961304.
    Results Reference
    background
    PubMed Identifier
    12505859
    Citation
    Ries AL, Kaplan RM, Myers R, Prewitt LM. Maintenance after pulmonary rehabilitation in chronic lung disease: a randomized trial. Am J Respir Crit Care Med. 2003 Mar 15;167(6):880-8. doi: 10.1164/rccm.200204-318OC. Epub 2002 Dec 27.
    Results Reference
    background

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    Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study

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