Study Testing Patient Decision Tools Related to the Risks and Benefits of Weight Loss Surgery (POINT of View)
Primary Purpose
Obesity, Morbid, Obesity, Decision Aids
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Decision Aid
Booklet Decision Aid
Sponsored by
About this trial
This is an interventional health services research trial for Obesity, Morbid
Eligibility 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
Sites / Locations
- Group Health Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
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.
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.
Full Information
NCT ID
NCT00666952
First Posted
April 23, 2008
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
Foundation for Informed Medical Decision Making
1. Study Identification
Unique Protocol Identification Number
NCT00666952
Brief Title
Study Testing Patient Decision Tools Related to the Risks and Benefits of Weight Loss Surgery
Acronym
POINT of View
Official Title
Randomized Trial of a Patient Decision Aid for Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Foundation for Informed Medical Decision Making
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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:
Determine if the bariatric decision aid results in superior bariatric surgery decision quality than an NIH booklet on weight loss surgery ('usual care').
Determine if the bariatric decision aid results in less decisional conflict and superior decisional self-efficacy than usual care.
Determine if there is a differential effect of the interventions on decision quality among treatment seekers and non-treatment seekers.
Investigate medical, psychological, and behavioral factors as mediators of treatment choice.
The secondary aims of this study are to:
Understand the current weight control attitudes and practices among morbidly obese patients who are not actively seeking bariatric surgical treatment.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Obesity, Decision Aids, Bariatric Surgery
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Video Decision Aid
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Booklet Decision Aid
Intervention Description
General educational booklet on gastrointestinal surgery developed by the NIH titled, 'Gastrointestinal Surgery for Severe Obesity'.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Arterburn, MD, MPH
Organizational Affiliation
Group Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
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Study Testing Patient Decision Tools Related to the Risks and Benefits of Weight Loss Surgery
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