Cost Analysis of Bariatric Surgery in an Employee-based Healthcare System Following Surgery Coverage
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|ClinicalTrials.gov Identifier: NCT02381704|
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : March 6, 2015
|Condition or disease|
Epidemiological studies show that the incidence of morbid obesity is increasing at a considerably greater rate than any other obesity category. The National Institutes of Health, along with a number of medical and scientific national and international professional organizations, recognize that bariatric surgery is the only long-term effective treatment for individuals with morbid obesity. Along with massive and sustained weight loss, bariatric surgery resolves/improves obesity co-morbidities (type 2 diabetes, hypertension, cardiovascular disease, fatty liver disease, asthma, osteoarthritis, fatty liver disease, obstructive sleep apnea, dyslipidemia, hyperlipidemia, infertility, depression, cancer risk, fertility, and more) and significantly increases longevity.
Despite the well-documented benefits of bariatric surgery in terms of health and healthcare costs, many insurers deny coverage for the surgery out of fear that the cost of surgery will financially burden the system. These insurers, however, fail to consider the improvement in obesity-related diseases and associated cost savings. The recent change in policy by the Florida Hospital Healthcare System (FHHS) that allows for partial coverage of bariatric surgery provides the unique opportunity to study prospectively the cost effectiveness of the surgery, i.e. cost of surgery vs. cost savings. Study participants will include approximately 75 to 100 FHHS covered individuals (18 to 64 years) who have been approved for bariatric surgery and who have provided their written consent for study participation.
The study protocol will include a review of patient insurance records for cost analysis of medication and medical expenses prior to surgery and over a two-year period postoperatively. Patients will also be asked to consent to the completion of a yearly questionnaire concerning the status of their obesity co-morbidities, medication use and dosage, and sick leave. The outcome of this prospective study will allow for assessment of the costs of surgery, cost saving in terms of medication and medical expenses, and the potential time period required for return on investment. Such data, when shared with others through peer-review journal publications, may assist other employee healthcare systems in their decision to provide coverage for bariatric procedures.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Cost Analysis of Bariatric Surgery in an Employee-based Healthcare System|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
- Changes in FHHS expenses pertaining to medical costs incurred by all study participants, as well as those study participants who, prior to their surgery, ranked in the (upper 50th. percentile) vs. (lower 50th. percentile) healthcare utilizing tiers. [ Time Frame: one to two years postop ]
- Determine changes in the cost of obesity-related co-morbidities for all study participants and those who, prior to surgery, were within high or low healthcare utilizing tiers. [ Time Frame: At the end of postoperative year 1 and 2 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381704
|United States, Florida|
|Advanced Minmially Invasive and Bariatric Surgery Consultants|
|Celebration, Florida, United States, 34747|
|Principal Investigator:||Keith C Kim, MD||Advanced Minimally Invasive and Bariatric Surgery Consultants|