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

This study has been completed.
Sponsor:
Collaborator:
Foundation for Informed Medical Decision Making
Information provided by:
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00666952
First received: April 23, 2008
Last updated: September 10, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Obesity, Morbid
Obesity
Decision Aids
Bariatric Surgery
Other: Video Decision Aid
Other: Booklet Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Randomized Trial of a Patient Decision Aid for Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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'.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666952

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Foundation for Informed Medical Decision Making
Investigators
Principal Investigator: David E Arterburn, MD, MPH Group Health Research Institute
  More Information

No publications provided

Responsible Party: Dr. David Arterburn, MD, MPH, Assistant Investigator, Group Health Research Institute
ClinicalTrials.gov Identifier: NCT00666952     History of Changes
Other Study ID Numbers: FIMDM IIG Grant 0094-1
Study First Received: April 23, 2008
Last Updated: September 10, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014