Improving Patient Decisions About Bariatric Surgery (PCORI)
Primary Purpose
Morbid Obesity, Weight Reduction
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Decider Guider: Weight Loss
Sponsored by
About this trial
This is an interventional other trial for Morbid Obesity
Eligibility Criteria
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Control
Decision Aid
Arm Description
Potential bariatric surgery patients who receive both the baseline questionnaire and follow-up questionnaire.
Potential bariatric surgery patients who receive both the baseline questionnaire decision aid/conjoint analysis and follow-up questionnaire.
Outcomes
Primary Outcome Measures
Decision outcome by Decider Guider Questionnaire
Decisional measures
Patient specific outcome by Decider Guider Questionnaire
Secondary Outcome Measures
Knowledge, as measured by a follow-up Decider Guider questionnaire to test knowledge
Preferences as measured by Decider Guider Questionnaire
Weight
Quality of Life as measured by Decider Guider Questionnaire
Comorbidity Resolution as measured by Decider Guider Questionnaire
Patient Satisfaction as measured by Decider Guider Questionnaire
Full Information
NCT ID
NCT02364128
First Posted
January 22, 2015
Last Updated
September 25, 2018
Sponsor
University of Michigan
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02364128
Brief Title
Improving Patient Decisions About Bariatric Surgery
Acronym
PCORI
Official Title
Patient-Centered Outcomes Research Institute (PCORI)- Improving Patient Decisions About Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
September 15, 2018 (Actual)
Study Completion Date
September 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Our specific aims are:
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Weight Reduction
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Potential bariatric surgery patients who receive both the baseline questionnaire and follow-up questionnaire.
Arm Title
Decision Aid
Arm Type
Other
Arm Description
Potential bariatric surgery patients who receive both the baseline questionnaire decision aid/conjoint analysis and follow-up questionnaire.
Intervention Type
Behavioral
Intervention Name(s)
Decider Guider: Weight Loss
Intervention Description
Decision aid tool about weight loss treatment
Primary Outcome Measure Information:
Title
Decision outcome by Decider Guider Questionnaire
Description
Decisional measures
Time Frame
24 months
Title
Patient specific outcome by Decider Guider Questionnaire
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Knowledge, as measured by a follow-up Decider Guider questionnaire to test knowledge
Time Frame
24 months
Title
Preferences as measured by Decider Guider Questionnaire
Time Frame
24 months
Title
Weight
Time Frame
24 months
Title
Quality of Life as measured by Decider Guider Questionnaire
Time Frame
24 months
Title
Comorbidity Resolution as measured by Decider Guider Questionnaire
Time Frame
24 months
Title
Patient Satisfaction as measured by Decider Guider Questionnaire
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
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Improving Patient Decisions About Bariatric Surgery
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