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Study Testing Patient Decision Tools Related to the Risks and Benefits of Weight Loss Surgery

NCT ID: NCT00666952

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Morbid Obesity Decision Aids Bariatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Video Decision Aid

Intervention Type OTHER

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.

2

Group Type ACTIVE_COMPARATOR

Booklet Decision Aid

Intervention Type OTHER

General educational booklet on gastrointestinal surgery developed by the NIH titled, 'Gastrointestinal Surgery for Severe Obesity'.

Interventions

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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.

Intervention Type OTHER

Booklet Decision Aid

General educational booklet on gastrointestinal surgery developed by the NIH titled, 'Gastrointestinal Surgery for Severe Obesity'.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Informed Medical Decision Making

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David E Arterburn, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Group Health Research Institute

Locations

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Group Health Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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FIMDM IIG Grant 0094-1

Identifier Type: -

Identifier Source: org_study_id