Clinical trial NCT00137956: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Emphysema
Chronic Obstructive Pulmonary Disease
Keywords: Endobronchial Valve
Endobronchial Valve ProcedureEBV
EBV Procedure
Endobronchial Lung Volume Reduction
Lung Volume Reduction
Lead sponsor: Emphasys Medical
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 270
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The cost-effectiveness ratio in the treatment group as compared to the control group at 180 days
Secondary outcomes:
measure: The cost-effectiveness ratio in the treatment group of the study will be compared to established therapies and standards.
Other outcomes:
Locations:
Study officials:
affiliation: UCLA School of Public Health, UCSD Health Outcomes Assessment Program (HOAP)
name: Robert Kaplan, PhD
role: PRINCIPAL_INVESTIGATOR
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