Skip to content

Improving Patient Decisions About Bariatric Surgery

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02364128
Acronym
PCORI
Enrollment
1000
Registered
2015-02-16
Start date
2014-01-01
Completion date
2018-09-15
Last updated
2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity, Weight Reduction

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: 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.

Interventions

BEHAVIORALDecider Guider: Weight Loss

Decision aid tool about weight loss treatment

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decision outcome by Decider Guider Questionnaire24 monthsDecisional measures
Patient specific outcome by Decider Guider Questionnaire24 months

Secondary

MeasureTime frame
Weight24 months
Quality of Life as measured by Decider Guider Questionnaire24 months
Knowledge, as measured by a follow-up Decider Guider questionnaire to test knowledge24 months
Patient Satisfaction as measured by Decider Guider Questionnaire24 months
Comorbidity Resolution as measured by Decider Guider Questionnaire24 months
Preferences as measured by Decider Guider Questionnaire24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026