Clinical trial NCT02381704: Cost Analysis of Bariatric Surgery in an Employee-based Healthcare System Following Surgery Coverage
Official title: Cost Analysis of Bariatric Surgery in an Employee-based Healthcare System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
First posted: 2015-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: one to two years postop
Secondary outcomes:
measure: 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.
timeFrame: At the end of postoperative year 1 and 2
Other outcomes:
Locations:
city: Celebration
country: United States
facility: Advanced Minmially Invasive and Bariatric Surgery Consultants
state: Florida
Study officials:
affiliation: Advanced Minimally Invasive and Bariatric Surgery Consultants
name: Keith C Kim, MD
role: PRINCIPAL_INVESTIGATOR
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