Morbid Obesity Clinical Trial
— PCORIOfficial title:
Patient-Centered Outcomes Research Institute (PCORI)- Improving Patient Decisions About Bariatric Surgery
Verified date | September 2018 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1000 |
Est. completion date | September 15, 2018 |
Est. primary completion date | September 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Patients under the age of 18 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decision outcome by Decider Guider Questionnaire | Decisional measures | 24 months | |
Primary | Patient specific outcome by Decider Guider Questionnaire | 24 months | ||
Secondary | Knowledge, as measured by a follow-up Decider Guider questionnaire to test knowledge | 24 months | ||
Secondary | Preferences as measured by Decider Guider Questionnaire | 24 months | ||
Secondary | Weight | 24 months | ||
Secondary | Quality of Life as measured by Decider Guider Questionnaire | 24 months | ||
Secondary | Comorbidity Resolution as measured by Decider Guider Questionnaire | 24 months | ||
Secondary | Patient Satisfaction as measured by Decider Guider Questionnaire | 24 months |
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