Improving Patient Decisions About Bariatric Surgery

Morbid Obesity Clinical Trial

— PCORI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364128
• Other study ID #: HUM00083670
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2014
• Est. completion date: September 15, 2018

Study information

• Verified date: September 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Weight Loss
• Weight Reduction

Intervention

Behavioral:
• Decider Guider: Weight Loss
Decision aid tool about weight loss treatment

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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