Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees
Study Details
Study Description
Brief Summary
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).
- 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;
- 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.
- 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Weight loss [0, 6, 12, and 24 months]
change in weight from baseline
- Body mass index (BMI) [0, 6, 12, and 24 months]
Change in body mass index (BMI) from baseline
Secondary Outcome Measures
- ecomonic outcomes [0, 6, 12, and 24 months]
costs to the insurance plan were assessed
- Systolic blood pressure [0, 6, 12, and 24 months]
change in systolic blood pressure from baseline
- Diastolic blood pressure [0, 6, 12, and 24 months]
change in diastolic blood pressure from baseline
- Medication use [0, 6, 12, and 24 months]
Change in mean number of medications prescribed
- quality of life [0, 6, 12, and 24 months]
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
- Work productivity [0, 6, 12, and 24 months]
Work productivity and activity impairment questionnaire: General Health v2.0 (WPAI:GH) assesses work productivity
Other Outcome Measures
- Surgery-related adverse events [24 months]
Any surgery-related adverse events were noted
Eligibility Criteria
Criteria
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
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two or more physician-supervised weight loss attempts within the last 24 months
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Mississippi Medical Center Comprehensive Weight Management Program | Jackson | Mississippi | United States | 39204 |
| 2 | Oxford Bariatric | Oxford | Mississippi | United States | 28677 |
| 3 | Oxford Surgical & Bariatric Clinic,LLC. | Oxford | Mississippi | United States | 38677 |
| 4 | South Mississippi Surgical Weight Loss Center | Pascagoula | Mississippi | United States | 39567 |
Sponsors and Collaborators
- University of Mississippi Medical Center
- Allergan
Investigators
- Principal Investigator: Katie S McClendon, Pharm.D., University of Mississippi Medical Center
Study Documents (Full-Text)
More Information
Publications
None provided.- 41165