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临床试验/NCT02364128
NCT02364128已完成2 期

Patient-Centered Outcomes Research Institute (PCORI)- Improving Patient Decisions About Bariatric Surgery

University of Michigan2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
1,000
试验地点
2
主要终点
Decision outcome by Decider Guider Questionnaire

研究概览

简要总结

At least 15 million Americans are morbidly obese, or more than 100 pounds overweight. Medical treatments including drugs and behavior modification have proven ineffective in producing significant and lasting weight loss in this group. While bariatric surgery is extremely effective for most patients, it also carries risks for both short and long-term complications. There are currently four different types of bariatric surgery available and the risks and benefits of these procedures vary widely and are strongly affected by patient and clinical characteristics.

Decision making under these circumstances should reflect informed patient's values and preferences regarding these trade-offs. Instead, the choice of bariatric procedure is more often driven by the beliefs and experiences of the bariatric surgeon that a patient happens to see. Variability in the type of surgery recommended to patients likely results from some combination of surgeons' subjective opinions and personal experiences with regard to the risks and benefits of the treatment options and delegated decision making on the part of patients.

The goals of this research proposal are to develop, implement, and evaluate an informed decision support tool for treatment of morbid obesity. This project will be conducted within the context of the Michigan Bariatric Surgery Collaborative (MBSC), which is a statewide clinical registry and quality improvement program that has the participation of virtually every bariatric surgeon and program in the state of Michigan. The MBSC registry now includes externally audited clinical data for more than 80,000 consecutive bariatric surgery patients. MBSC outcome measures include complications occurring within 30 days as well as weight loss, comorbidity resolution, quality of life and satisfaction at 1, 2, and 3 years after bariatric surgery.

详细描述

Our specific aims are:

  1. To develop a web-based interactive decision support tool to incorporate tailored information regarding risks and benefits of the treatment options (from regression-based prediction models derived on the 35,000 patients already in the MBSC registry) with information regarding other salient attributes of the treatment options (derived from focus groups and semi-structured interviews with stakeholders including bariatric surgery patients, bariatric program staff, and surgeons).
  2. To perform a quasi-experimental study comparing the decision support tool with usual care to determine its effects on patient decisions (treatment choice, knowledge, treatment-preference concordance, and decisional conflict) and on patient outcomes including weight loss, patient satisfaction, and improvements in quality of life after surgery.

This research is closely aligned with the goals of PCORI and will have direct impacts on patients and caregivers by providing information that is required to improve healthcare decision-making for this prevalent, damaging, and costly condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients considering undergoing bariatric surgery in the state of Michigan who are 18 or older.
  • All patients, regardless of gender or racial/ethnic background, will be recruited to participate in the study in the same way.

排除标准

  • Patients under the age of 18

结局指标

主要结局

Decision outcome by Decider Guider Questionnaire

时间窗: 24 months

Decisional measures

Patient specific outcome by Decider Guider Questionnaire

时间窗: 24 months

次要结局

  • Knowledge, as measured by a follow-up Decider Guider questionnaire to test knowledge(24 months)
  • Weight(24 months)
  • Preferences as measured by Decider Guider Questionnaire(24 months)
  • Comorbidity Resolution as measured by Decider Guider Questionnaire(24 months)
  • Quality of Life as measured by Decider Guider Questionnaire(24 months)
  • Patient Satisfaction as measured by Decider Guider Questionnaire(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amir Ghaferi

Assistant Professor of Surgery

University of Michigan

研究点 (2)

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