Study Testing Patient Decision Tools Related to the Risks and Benefits of Weight Loss Surgery
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 20 - 65 |
| Updated: | 10/15/2017 |
| Start Date: | May 2008 |
| End Date: | January 2009 |
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
