Morbid Obesity Clinical Trial
Official title:
Patient-Centered Outcomes Research Institute (PCORI)- Improving Patient Decisions About Bariatric Surgery
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.
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.
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