Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees

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.

Study Overview

• Status: Completed
• Conditions: Obesity

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39204
      • Central Mississippi Medical Center Comprehensive Weight Management Program
    • Oxford, Mississippi, United States, 28677
      • Oxford Bariatric
    • Oxford, Mississippi, United States, 38677
      • Oxford Surgical & Bariatric Clinic,LLC.
    • Pascagoula, Mississippi, United States, 39567
      • South Mississippi Surgical Weight Loss Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

200 obese patients with Mississippi State Employee Insurance who undergo bariatric surgery as part of Obesity Treatment Program

Description

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

  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. 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.

Study Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery-related adverse events	Any surgery-related adverse events were noted	24 months

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Collaborators: Allergan
• Investigators: Principal Investigator: Katie S McClendon, Pharm.D., University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: July 13, 2010
• First Submitted That Met QC Criteria: July 13, 2010
• First Posted (Estimate): July 14, 2010

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: obesity; bariatric surgery; outcomes
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 41165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO