Cost Analysis of Bariatric Surgery in an Employee-based Healthcare System Following Surgery Coverage

NCT ID: NCT02381704

Last Updated: 2015-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-08-31

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.

Conditions

Morbid Obesity

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: collaborator

AdventHealth

OTHER

Sponsor Role: lead

Responsible Party

Dr. Keith Kim

Director of Metabolic Medicine & Surgery Institute at Celebration Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keith C Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Minimally Invasive and Bariatric Surgery Consultants

Locations

Advanced Minmially Invasive and Bariatric Surgery Consultants

Celebration, Florida, United States

Countries

United States

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Other Identifiers

08.03.08

Identifier Type: -

Identifier Source: org_study_id