Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees

Study Overview
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Brief Summary
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Objective: to assess the health and economic outcomes (weight lost, change in control of chronic diseases such as diabetes, quality of life, work productivity, health care cost, etc) associated with bariatric (weight-loss) surgery for 200 severely obese patients who undergo bariatric surgery as part of the Mississippi State Employees' Life and Health Insurance Plan's Obesity Treatment Program (OTP). 2. Patient Characteristics: Inclusion criteria: Eligible bariatric surgical candidates who are enrolled in the OTP (100 patients per year for 2 years). The Plan's criteria includes, but is not limited to 1) enrollment in the plan for at least 12 consecutive months prior to September 1, 2009; 2) completion of the HealthQuotient health risk assessment through the Plan's wellness and health promotion program; 3) a Body Mass Index (BMI) of >40 kg/m2, or a BMI >35 kg/m2 with two or more co-morbidities such as diabetes, hypertension, sleep apnea or asthma; 4) two or more physician-supervised weight loss attempts within the last 24 months; 5) age 18 years or older; and 6) consent to provide personal and medical information to the Plan. Prior to surgery, each site administers a psychiatric evaluation to ensure the patient is psychologically stable for surgery. Exclusion criteria: any patient who does not meet criteria above or who declines to participate. Surgeries will take place only at Certified Bariatric Surgery Centers of Excellence (COE), of which, there are currently 3 in the state. The 3 COEs exist with 4 outpatient medical offices (1 COE is composed of 2 independent surgeon practices) Patients will be recruited at each site once they are approved by the OTP. 3. Design: prospective, observational, multi-center, longitudinal study of outcomes and resource utilization associated with OTP. Estimates of obesity and comorbidities' impact will be obtained from the outpatient medical office for the COEs. Medical charts, databases and medical/pharmacy claims will be the source of information. Surveys on quality of life, productivity, and patient satisfaction will be administered directly to patients. Database claim information will be obtained in future and is not a part of current IRB application. 4: Procedures: After obtaining informed consent, patients will be administered surveys at baseline, as well as at follow-up visits. Additional data will be obtained via patient charts, databases, and medical/pharmacy claims.

Official Title
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Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees

Conditions
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Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible bariatric surgical candidates who are enrolled in the Mississippi SSELHI Plan (100 candidates enrolled per year). The Plan's criteria includes, but is not limited to enrollment in the plan for at least 12 consecutive months prior to September 1, 2009 completion of the HealthQuotient health risk assessment through the Plan's wellness and health promotion program a Body Mass Index (BMI) of >40 kg/m2, or a BMI >35 kg/m2 with two or more co-morbidities such as diabetes, hypertension, sleep apnea or asthma two or more physician-supervised weight loss attempts within the last 24 months consent to provide personal and medical information to the Plan Exclusion Criteria: Any patient who does not meet criteria above or who declines to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | change in weight from baseline | 0, 6, 12, and 24 months | 
| Body mass index (BMI) | Change in body mass index (BMI) from baseline | 0, 6, 12, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ecomonic outcomes | costs to the insurance plan were assessed | 0, 6, 12, and 24 months | 
| Systolic blood pressure | change in systolic blood pressure from baseline | 0, 6, 12, and 24 months | 
| Diastolic blood pressure | change in diastolic blood pressure from baseline | 0, 6, 12, and 24 months | 
| Medication use | Change in mean number of medications prescribed | 0, 6, 12, and 24 months | 
| quality of life | Impact of weight on quality of life (IWQOL-lite) questionnaire; tool assesses 5 domains of quality of life: physical function, self-esteem, sexual life, public distress, and work impact | 0, 6, 12, and 24 months | 
| Work productivity | Work productivity and activity impairment questionnaire: General Health v2.0 (WPAI:GH) assesses work productivity | 0, 6, 12, and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, obesity, outcomes