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.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Mississippi
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Jackson、Mississippi、美国、39204
- Central Mississippi Medical Center Comprehensive Weight Management Program
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Oxford、Mississippi、美国、28677
- Oxford Bariatric
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Oxford、Mississippi、美国、38677
- Oxford Surgical & Bariatric Clinic,LLC.
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Pascagoula、Mississippi、美国、39567
- South Mississippi Surgical Weight Loss Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Weight loss
大体时间:0, 6, 12, and 24 months
|
change in weight from baseline
|
0, 6, 12, and 24 months
|
Body mass index (BMI)
大体时间:0, 6, 12, and 24 months
|
Change in body mass index (BMI) from baseline
|
0, 6, 12, and 24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
ecomonic outcomes
大体时间:0, 6, 12, and 24 months
|
costs to the insurance plan were assessed
|
0, 6, 12, and 24 months
|
Systolic blood pressure
大体时间:0, 6, 12, and 24 months
|
change in systolic blood pressure from baseline
|
0, 6, 12, and 24 months
|
Diastolic blood pressure
大体时间:0, 6, 12, and 24 months
|
change in diastolic blood pressure from baseline
|
0, 6, 12, and 24 months
|
Medication use
大体时间:0, 6, 12, and 24 months
|
Change in mean number of medications prescribed
|
0, 6, 12, and 24 months
|
quality of life
大体时间: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
|
0, 6, 12, and 24 months
|
Work productivity
大体时间:0, 6, 12, and 24 months
|
Work productivity and activity impairment questionnaire: General Health v2.0 (WPAI:GH) assesses work productivity
|
0, 6, 12, and 24 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Surgery-related adverse events
大体时间:24 months
|
Any surgery-related adverse events were noted
|
24 months
|
合作者和调查者
合作者
调查人员
- 首席研究员:Katie S McClendon, Pharm.D.、University of Mississippi Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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