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

March 5, 2015 updated by: Dr. Keith Kim, AdventHealth

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Celebration, Florida, United States, 34747
        • Advanced Minmially Invasive and Bariatric Surgery Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one to two years postop

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At the end of postoperative year 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Collaborators

Ethicon Endo-Surgery

Investigators

  • Principal Investigator: Keith C Kim, MD, Advanced Minimally Invasive and Bariatric Surgery Consultants

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08.03.08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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