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Adjustable Gastric Band Survey Study (AGB)

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ClinicalTrials.gov Identifier: NCT01041534
Recruitment Status : Unknown
Verified July 2012 by David Flum, University of Washington.
Recruitment status was:  Active, not recruiting
First Posted : December 31, 2009
Last Update Posted : July 6, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Our aim is to complete a survey study of patients who have undergone Adjustable Gastric Band (AGB) surgery at the University of Washington Medical Center (UWMC) and expanded to other bariatric surgical sites outside the University of Washington (UW), which will obtain a HIPAA waiver and a letter of cooperation) between April 1, 2007 and July 1, 2008. (Please note the University of Washington team will not have access to the site's list of patients, only access to coded returned surveys sent back from patients). Patients will be identified by obtaining operative case lists from the Department of Surgery Quality Improvement Team who maintain monthly records of bariatric procedures performed. We will obtain patient contact information (address) and patients will be contacted by mail with the request that they complete both the Adjustable Gastric Band (AGB) Health Survey and a standard Quality of Life survey (EQ5D). The mailing will include an Information Statement, the AGB Survey, the EQ5D, and a stamped return envelope. As an incentive, a $2 bill will be sent along with the first mailing to cover the costs of completing and returning the surveys. Patients who do not return survey within 30 days will be mailed a second survey. Patients who do not return the second survey within 30 days will be mailed a third survey. Patients who do not return the third survey will not be re-contacted.

Condition or disease Intervention/treatment
Morbid Obesity Other: Survey

Detailed Description:

While there has been considerable energy focused on the costs and effectiveness of bariatric surgery, there has been little systematically-gathered evidence on the non-surgical care and healthcare expenditures for similarly burdened patients. The economic burden and clinical impact of both need to be more carefully defined to help guide DOD decision making regarding obesity care. Understanding the cost effectiveness of obesity treatments is also critical given the cost of treatment procedures, their potential for saving future costs related to co-morbid health conditions and worker productivity and the growing population of operative candidates.

This study will provide a comprehensive assessment of the burden and costs of operative and non-operative obesity care across all regions in the U.S. where the Department of Defense (DOD) authorizes care. The development of economic assessment tools will allow health policy experts, purchasers and payers of healthcare, clinicians and patients to determine the utility and cost-effectiveness of available treatment strategies. These economic considerations are relevant to the competing crises of spiraling health care costs and the loss of productivity related to obesity.

The specific purpose of this study is to provide a comprehensive assessment of the burden and costs of operative and non-operative obesity care to develop a set of economic assessment tools that will allow health policy experts, purchasers and payers of healthcare, clinicians and patients to determine the utility and cost-effectiveness of available treatment strategies for managing obesity. Utility refers to qualitative components affected by clinical conditions such as individual's perceptions of quality of life, ability to take care of one-self, or ability to work/be productive. We anticipate that utility changes greatly for people who are able to achieve weight loss, but the differences or degree to which operative and non-operative weight loss treatments affects utility is not well known.

In particular, less is known about the effect of Adjustable Gastric Band (AGB) surgery on utility because it has only emerged as a predominant form of surgical treatment in the United States approximately within the last five years - for example, the first AGB surgery at UWMC was only performed in April 2007. In addition, assessment of cost-effectiveness of treatments requires understanding healthcare use after treatment (i.e. how many follow-up visits do you have with a doctor because of your surgical treatment) and AGB requires frequent follow-up visits in the first three years to make the surgical treatment effective. There is little information or research reporting the actual frequency of which patients are receiving follow-up care after AGB surgery, the cost for that care (is it a patient cost or insurance covered), or whether frequency of follow-up care affects long-term weight loss or health outcomes.

While the original procedures of our related study (IRB #35310, Committee E/A) only included secondary analysis of existing datasets, we have found very little information about qualitative utility or use/frequency of follow-up care for AGB patients and feel these are important aspects for modeling treatment choices for patients considering AGB. By adding a survey component, we will capture these data elements that are otherwise not found in literature or administrative datasets.


Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Data Investigation of Bariatric Surgery and Economic Savings: Adjustable Gastric Band (AGB) Survey Study
Study Start Date : July 2009
Primary Completion Date : July 2011
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Adjustable Gastric Band (AGB) surgery
Patients who have undergone adjustable gastric band (AGB) surgery at the UWMC or other sites that have agreed to cooperate with our site (letter of cooperation and HIPAA waiver approved by our IRB) between April 1, 2007 and July 1, 2008.
Other: Survey
Two surveys are sent to patients: Adjustable gastric band (AGB) Health Survey and a quality of life survey (EQ5D)


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have undergone adjustable gastric band (AGB) surgery between April 1, 2007 and July 1, 2008 at University of Washington Medical Center (UWMC) or other sites that have been approved by our IRB (all within the Washington State area).
Criteria

Inclusion Criteria:

  • All patients that have undergone Adjustable gastric band (AGB bariatric surgery) and those with diagnoses of morbid obesity will be included. All patients having a AGB bariatric operation between April 1, 2007 and July 1, 2008 will be included in this analysis except for those with exclusionary diagnoses.

Exclusion Criteria:

  • Current "Longitudinal Assessment of Bariatric Surgery (LABS)" study participation (note: LABS study captures similar information on utility and frequency of healthcare use, but has not yet published data that we could otherwise incorporate into our study. All LABS study sites, as University of Washington Medical Center (UWMC) is, are prohibited from duplicating research efforts in LABS enrolled patients to reduce burden on patients and conflict of interest in research reporting)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041534


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98119
Sponsors and Collaborators
University of Washington
United States Department of Defense
Investigators
Principal Investigator: David R Flum, MD, MPH University of Washington
More Information

Responsible Party: David Flum, David R. Flum, MD, MPH, University of Washington
ClinicalTrials.gov Identifier: NCT01041534     History of Changes
Other Study ID Numbers: 36720-E/A
BA-08-01/Log 2 ( Other Identifier: Ventura Healthcare systems, LLC )
FA7014-08-2-0002 ( Other Grant/Funding Number: Department of Defense, Air Force District Washington )
First Posted: December 31, 2009    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012

Keywords provided by David Flum, University of Washington:
Adjustable gastric band, morbid obesity, bariatric surgery

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