Clinical trial NCT01162668: Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees
Official title: Assessment of Outcomes Following Bariatric Surgery for Mississippi State Employees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: bariatric surgery
obesity
outcomes
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2010-07-14
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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).

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.


Eligibility 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

  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.

Primary outcomes:
measure: Weight loss
timeFrame: 0, 6, 12, and 24 months
measure: Body mass index (BMI)
timeFrame: 0, 6, 12, and 24 months
Secondary outcomes:
measure: ecomonic outcomes
timeFrame: 0, 6, 12, and 24 months
measure: Systolic blood pressure
timeFrame: 0, 6, 12, and 24 months
measure: Diastolic blood pressure
timeFrame: 0, 6, 12, and 24 months
measure: Medication use
timeFrame: 0, 6, 12, and 24 months
measure: quality of life
timeFrame: 0, 6, 12, and 24 months
measure: Work productivity
timeFrame: 0, 6, 12, and 24 months
Other outcomes:
measure: Surgery-related adverse events
timeFrame: 24 months
Locations:
city: Jackson
country: United States
facility: Central Mississippi Medical Center Comprehensive Weight Management Program
state: Mississippi
city: Oxford
country: United States
facility: Oxford Bariatric
state: Mississippi
city: Oxford
country: United States
facility: Oxford Surgical & Bariatric Clinic,LLC.
state: Mississippi
city: Pascagoula
country: United States
facility: South Mississippi Surgical Weight Loss Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Katie S McClendon, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: