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Trial record 23 of 27 for:    15479938 [PUBMED-IDS]

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
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Dr. Keith Kim, Florida Hospital

Brief Summary:
The overall purpose of the study is to determine prospectively the cost effectiveness of bariatric surgery following partial coverage by a large healthcare system.

Condition or disease
Morbid Obesity

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study subjects will include any individual having been approved for surgery that consents to the review of their records and additional survey information pertaining to medication use, dosage, anthropometrics and medical-related days taken. Study subjects would include male and female gender, all ethnicities, ages 18 to 65 years, and exclude populations who do not meet the criteria for bariatric surgery
Criteria

Inclusion Criteria:

  • Insured under the FHHS
  • Have been approved for bariatric surgery
  • Have provided their written consent for study participation.

Exclusion Criteria:

  • Approved bariatric surgery patients covered by (FHHS)Florida Hospital Healthcare Systems will be excluded from the study if they fail to provide written consent.
  • Surgery exclusion:

BMI less than or equal to 35 without at least two major co-morbidities pregnancy active alcoholism or drug abuse suicidal ideation cancer or another wasting disease mental handicap and inability to provide written consent.


Information from the National Library of Medicine

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


Locations
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United States, Florida
Advanced Minmially Invasive and Bariatric Surgery Consultants
Celebration, Florida, United States, 34747
Sponsors and Collaborators
Florida Hospital
Ethicon Endo-Surgery
Investigators
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Principal Investigator: Keith C Kim, MD Advanced Minimally Invasive and Bariatric Surgery Consultants

Publications of Results:
6. CDC. Obesity and overweight trends. http://www.cdc.gov/nccdphp/dnpa/obesity/trend/index.htm
Buffington CK, Cowan GSM, Jr. Gastric Bypass in the Treatment of Diabetes, Hypertension and Lipid/lipoprotein Abnormalities of the Morbidly Obese. In Deitel M (ed.): Companion Volume to Obesity Surgery for the Morbidly Obese Patient. 2000 by FD Publications, Toronto, Canada, pp. 435-450.
North American Association for the Study of Obesity and the National Heart, Lung, and Blood Institute. The practical guide: identification, evaluation and treatment of overweight and obesity in adults. Bethesda, MD. National Institutes of Health, 2000, NIH Publication 00-4084.
North American Association for the Study of Obesity and the National Heart, Lung, and Blood Institute. Clinical Guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. The Evidence Report. Bethesda, Md: National Institutes of Health, 1998. NIH Publication 98-4083.

Other Publications:

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Responsible Party: Dr. Keith Kim, Director of Metabolic Medicine & Surgery Institute at Celebration Health, Florida Hospital
ClinicalTrials.gov Identifier: NCT02381704     History of Changes
Other Study ID Numbers: 08.03.08
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms