Clinical trial NCT00666952: Study Testing Patient Decision Tools Related to the Risks and Benefits of Weight Loss Surgery
Official title: Randomized Trial of a Patient Decision Aid for Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Obesity
Decision Aids
Bariatric Surgery
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Foundation for Informed Medical Decision Making
First posted: 2008-04-25
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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.


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

Primary outcomes:
measure: 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.
timeFrame: 3 Months
Secondary outcomes:
measure: Our secondary aims will examine the impact of our interventions or decisional conflict, decisional self-efficacy, and explore potential mediators of our intervention effects.
timeFrame: 3 Months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Group Health Research Institute
name: David E Arterburn, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: