Study Testing Patient Decision Tools Related to the Risks and Benefits of Weight Loss Surgery (POINT of View)

October 11, 2017 updated by: Kaiser Permanente

Randomized Trial of a Patient Decision Aid for Bariatric Surgery

Morbid obesity currently affects more than 11 million US adults and is strongly associated with type 2 diabetes, cancer, cardiovascular disease, and arthritis. Bariatric (weight loss) surgical procedures have been shown to significantly reduce body weight and improve the health and quality of life of morbidly obese adults, at least in the short term. However, bariatric surgery also presents substantial risks, including a 10% to 20% risk of serious complications and up to a 2% risk of death in the first 30 days after surgery. Thus, a morbidly obese patient's decision regarding bariatric surgery should be based on his or her evaluation of accurate information on the possible risks and benefits of the various treatment options. Anecdotal reports suggest that bariatric treatment decisions may be more heavily influenced by insurance coverage and reimbursement rates than patient preferences.

The main objective of the current proposal is to examine the impact of a bariatric decision aid, Weight loss surgery: Is it right for you?, on decision quality in primary care and bariatric specialty practice settings. We propose a randomized controlled trial to assess the effect of this bariatric decision aid on bariatric-specific measures of patient knowledge, values and choice of weight management strategy. We will also investigate the effect of the decision aid on decisional conflict and decisional self-efficacy and examine medical, psychological, and behavioral factors as mediators and moderators of treatment choice. This information will help to elucidate the value of this decision aid in improving decision quality.

The primary aims of this of this research are to:

  1. Determine if the bariatric decision aid results in superior bariatric surgery decision quality than an NIH booklet on weight loss surgery ('usual care').
  2. Determine if the bariatric decision aid results in less decisional conflict and superior decisional self-efficacy than usual care.
  3. Determine if there is a differential effect of the interventions on decision quality among treatment seekers and non-treatment seekers.
  4. Investigate medical, psychological, and behavioral factors as mediators of treatment choice.

The secondary aims of this study are to:

  1. Understand the current weight control attitudes and practices among morbidly obese patients who are not actively seeking bariatric surgical treatment.
  2. Assess the rates of bariatric surgery, health care costs, health care use and outcomes, and changes in BMI over time across the intervention groups, as well as across study subgroups, such as those who did and did not choose to have bariatric surgery.

We hypothesize that the decision aid will result in greater knowledge and greater values concordance, less decisional conflict and superior decisional self-efficacy than the NIH booklet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Group Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 20 to 65 years
  • enrolled in Group Health and not planning to discontinue enrollment during study period
  • meet standard NIH eligibility criteria for bariatric surgery
  • reside in King County;
  • have a phone
  • are able to read, write and speak in English
  • report no physical or hearing impairments which would prevent engaging in the study assessments

Exclusion Criteria:

  • Pregnant, lactating, or planning to become pregnant in the next two years
  • have any contraindications to bariatric surgery
  • previously undergone a bariatric procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Other: Video Decision Aid
Participants randomized to the video decision aid group will be asked to view the video portion of the decision aid, Weight loss surgery: Is it right for you? in a private room The content of the video and accompanying booklet was based on a systematic-review of the efficacy and safety of bariatric surgery, input from experts in bariatric surgery, internal medicine, psychology, nutrition, and nursing, and from a series of focus groups and interviews with 30 morbidly obese patients, some of whom had elected not to have bariatric surgery.
Active Comparator: 2
Other: Booklet Decision Aid
General educational booklet on gastrointestinal surgery developed by the NIH titled, 'Gastrointestinal Surgery for Severe Obesity'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Our primary focus is estimating the benefit of the decision aid on decision quality. The two components of decision quality are knowledge and value concordance.
Time Frame: 3 Months
3 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Our secondary aims will examine the impact of our interventions or decisional conflict, decisional self-efficacy, and explore potential mediators of our intervention effects.
Time Frame: 3 Months
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

Foundation for Informed Medical Decision Making

Investigators

  • Principal Investigator: David E Arterburn, MD, MPH, Group Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIMDM IIG Grant 0094-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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