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Completed

NCT Number: NCT02364128

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decider Guider: Weight Loss

Behavioral

Decision aid tool about weight loss treatment

Primary outcomes

  1. Decision outcome by Decider Guider Questionnaire

    Time frame: 24 months

    Decisional measures

  2. Patient specific outcome by Decider Guider Questionnaire

    Time frame: 24 months

Secondary outcomes

  1. Knowledge, as measured by a follow-up Decider Guider questionnaire to test knowledge

    Time frame: 24 months

  2. Preferences as measured by Decider Guider Questionnaire

    Time frame: 24 months

  3. Weight

    Time frame: 24 months

  4. Quality of Life as measured by Decider Guider Questionnaire

    Time frame: 24 months

  5. Comorbidity Resolution as measured by Decider Guider Questionnaire

    Time frame: 24 months

  6. Patient Satisfaction as measured by Decider Guider Questionnaire

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: PCORI

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 16, 2015
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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