Morbid ObesityNCT02381704
Cost Analysis of Bariatric Surgery in an Employee-based Healthcare System Following Surgery Coverage
An observational study of Morbid Obesity, run by AdventHealth at 1 site in United States.
Trial summary
The overall purpose of the study is to determine prospectively the cost effectiveness of bariatric surgery following partial coverage by a large healthcare system. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Morbid Obesity
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Study subjects will include any individual having been approved for surgery that consents to the review of their records and additional survey information pertaining to medication use, dosage, anthropometrics and medical-related days taken. Study subjects would include male and female gender, all ethnicities, ages 18 to 65 years, and exclude populations who do not meet the criteria for bariatric surgery
Who may be able to join
- Insured under the FHHS
- Have been approved for bariatric surgery
- Have provided their written consent for study participation.
Who cannot join
- Approved bariatric surgery patients covered by (FHHS)Florida Hospital Healthcare Systems will be excluded from the study if they fail to provide written consent.
- Surgery exclusion:
- BMI less than or equal to 35 without at least two major co-morbidities pregnancy active alcoholism or drug abuse suicidal ideation cancer or another wasting disease mental handicap and inability to provide written consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Minmially Invasive and Bariatric Surgery Consultants
Celebration, Florida, 34747
About this study
Official title: Cost Analysis of Bariatric Surgery in an Employee-based Healthcare System
The overall purpose of the study is to determine prospectively the cost effectiveness of bariatric surgery following partial coverage by a large healthcare system.
Read the detailed description
Epidemiological studies show that the incidence of morbid obesity is increasing at a considerably greater rate than any other obesity category. The National Institutes of Health, along with a number of medical and scientific national and international professional organizations, recognize that bariatric surgery is the only long-term effective treatment for individuals with morbid obesity. Along with massive and sustained weight loss, bariatric surgery resolves/improves obesity co-morbidities (type 2 diabetes, hypertension, cardiovascular disease, fatty liver disease, asthma, osteoarthritis, fatty liver disease, obstructive sleep apnea, dyslipidemia, hyperlipidemia, infertility, depression, cancer risk, fertility, and more) and significantly increases longevity.
Despite the well-documented benefits of bariatric surgery in terms of health and healthcare costs, many insurers deny coverage for the surgery out of fear that the cost of surgery will financially burden the system. These insurers, however, fail to consider the improvement in obesity-related diseases and associated cost savings. The recent change in policy by the Florida Hospital Healthcare System (FHHS) that allows for partial coverage of bariatric surgery provides the unique opportunity to study prospectively the cost effectiveness of the surgery, i.e. cost of surgery vs. cost savings. Study participants will include approximately 75 to 100 FHHS covered individuals (18 to 64 years) who have been approved for bariatric surgery and who have provided their written consent for study participation.
The study protocol will include a review of patient insurance records for cost analysis of medication and medical expenses prior to surgery and over a two-year period postoperatively. Patients will also be asked to consent to the completion of a yearly questionnaire concerning the status of their obesity co-morbidities, medication use and dosage, and sick leave. The outcome of this prospective study will allow for assessment of the costs of surgery, cost saving in terms of medication and medical expenses, and the potential time period required for return on investment. Such data, when shared with others through peer-review journal publications, may assist other employee healthcare systems in their decision to provide coverage for bariatric procedures.
- Conditions
- Morbid Obesity
- Medical subject headings
- Obesity, Morbid
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in FHHS expenses pertaining to medical costs incurred by all study participants, as well as those study participants who, prior to their surgery, ranked in the (upper 50th. percentile) vs. (lower 50th. percentile) healthcare utilizing tiers.
Measured: one to two years postop
Secondary outcomes (1)
Determine changes in the cost of obesity-related co-morbidities for all study participants and those who, prior to surgery, were within high or low healthcare utilizing tiers.
Measured: At the end of postoperative year 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startApr 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Responsible party
- Principal investigator, Dr. Keith Kim, AdventHealth
- Investigators
- Keith C Kim, MD, Principal investigator, Advanced Minimally Invasive and Bariatric Surgery Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381704
- Sponsor's protocol ID
- 08.03.08
- Status last verified
- Mar 2015
- First submitted
- 5 Mar 2015
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Seidell JC. Obesity, insulin resistance and diabetes--a worldwide epidemic. Br J Nutr. 2000 Mar;83 Suppl 1:S5-8. doi: 10.1017/s000711450000088x.
PubMed 10889785Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.
PubMed 12365955Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002 Oct 9;288(14):1728-32. doi: 10.1001/jama.288.14.1728.
PubMed 12365956Freedman DS, Khan LK, Serdula MK, Galuska DA, Dietz WH. Trends and correlates of class 3 obesity in the United States from 1990 through 2000. JAMA. 2002 Oct 9;288(14):1758-61. doi: 10.1001/jama.288.14.1758.
PubMed 12365960Mokdad AH, Serdula MK, Dietz WH, Bowman BA, Marks JS, Koplan JP. The spread of the obesity epidemic in the United States, 1991-1998. JAMA. 1999 Oct 27;282(16):1519-22. doi: 10.1001/jama.282.16.1519.
PubMed 10546690Calle EE, Thun MJ, Petrelli JM, Rodriguez C, Heath CW Jr. Body-mass index and mortality in a prospective cohort of U.S. adults. N Engl J Med. 1999 Oct 7;341(15):1097-105. doi: 10.1056/NEJM199910073411501.
PubMed 10511607Drenick EJ, Bale GS, Seltzer F, Johnson DG. Excessive mortality and causes of death in morbidly obese men. JAMA. 1980 Feb 1;243(5):443-5.
PubMed 7351764McGee DL; Diverse Populations Collaboration. Body mass index and mortality: a meta-analysis based on person-level data from twenty-six observational studies. Ann Epidemiol. 2005 Feb;15(2):87-97. doi: 10.1016/j.annepidem.2004.05.012.
PubMed 15652713Sjostrom LV. Mortality of severely obese subjects. Am J Clin Nutr. 1992 Feb;55(2 Suppl):516S-523S. doi: 10.1093/ajcn/55.2.516s.
PubMed 1531097Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
PubMed 15479938Maggard MA, Shugarman LR, Suttorp M, Maglione M, Sugerman HJ, Livingston EH, Nguyen NT, Li Z, Mojica WA, Hilton L, Rhodes S, Morton SC, Shekelle PG. Meta-analysis: surgical treatment of obesity. Ann Intern Med. 2005 Apr 5;142(7):547-59. doi: 10.7326/0003-4819-142-7-200504050-00013.
PubMed 15809466Christou NV, Sampalis JS, Liberman M, Look D, Auger S, McLean AP, MacLean LD. Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients. Ann Surg. 2004 Sep;240(3):416-23; discussion 423-4. doi: 10.1097/01.sla.0000137343.63376.19.
PubMed 15319713Kushner RF, Noble CA. Long-term outcome of bariatric surgery: an interim analysis. Mayo Clin Proc. 2006 Oct;81(10 Suppl):S46-51. doi: 10.1016/s0025-6196(11)61180-4.
PubMed 17036578O'Brien PE, McPhail T, Chaston TB, Dixon JB. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006 Aug;16(8):1032-40. doi: 10.1381/096089206778026316.
PubMed 16901357Sugerman HJ. Bariatric surgery for severe obesity. J Assoc Acad Minor Phys. 2001 Jul;12(3):129-36.
PubMed 11851201
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Analysis of Bariatric Surgery in an Employee-based Healthcare System
- ClinicalTrials.gov ID
- NCT02381704
- Acronym / sponsor ID
- 08.03.08
- Conditions
- Morbid Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Apr 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of the study is to determine prospectively the cost effectiveness of bariatric surgery following partial coverage by a large healthcare system.
Detailed description
Epidemiological studies show that the incidence of morbid obesity is increasing at a considerably greater rate than any other obesity category. The National Institutes of Health, along with a number of medical and scientific national and international professional organizations, recognize that bariatric surgery is the only long-term effective treatment for individuals with morbid obesity. Along with massive and sustained weight loss, bariatric surgery resolves/improves obesity co-morbidities (type 2 diabetes, hypertension, cardiovascular disease, fatty liver disease, asthma, osteoarthritis, fatty liver disease, obstructive sleep apnea, dyslipidemia, hyperlipidemia, infertility, depression, cancer risk, fertility, and more) and significantly increases longevity.
Despite the well-documented benefits of bariatric surgery in terms of health and healthcare costs, many insurers deny coverage for the surgery out of fear that the cost of surgery will financially burden the system. These insurers, however, fail to consider the improvement in obesity-related diseases and associated cost savings. The recent change in policy by the Florida Hospital Healthcare System (FHHS) that allows for partial coverage of bariatric surgery provides the unique opportunity to study prospectively the cost effectiveness of the surgery, i.e. cost of surgery vs. cost savings. Study participants will include approximately 75 to 100 FHHS covered individuals (18 to 64 years) who have been approved for bariatric surgery and who have provided their written consent for study participation.
The study protocol will include a review of patient insurance records for cost analysis of medication and medical expenses prior to surgery and over a two-year period postoperatively. Patients will also be asked to consent to the completion of a yearly questionnaire concerning the status of their obesity co-morbidities, medication use and dosage, and sick leave. The outcome of this prospective study will allow for assessment of the costs of surgery, cost saving in terms of medication and medical expenses, and the potential time period required for return on investment. Such data, when shared with others through peer-review journal publications, may assist other employee healthcare systems in their decision to provide coverage for bariatric procedures.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study subjects will include any individual having been approved for surgery that consents to the review of their records and additional survey information pertaining to medication use, dosage, anthropometrics and medical-related days taken. Study subjects would include male and female gender, all ethnicities, ages 18 to 65 years, and exclude populations who do not meet the criteria for bariatric surgery
Key inclusion criteria (3 listed)
- Insured under the FHHS
- Have been approved for bariatric surgery
- Have provided their written consent for study participation.
Key exclusion criteria (3 listed)
- Approved bariatric surgery patients covered by (FHHS)Florida Hospital Healthcare Systems will be excluded from the study if they fail to provide written consent.
- Surgery exclusion:
- BMI less than or equal to 35 without at least two major co-morbidities pregnancy active alcoholism or drug abuse suicidal ideation cancer or another wasting disease mental handicap and inability to provide written consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in FHHS expenses pertaining to medical costs incurred by all study participants, as well as those study participants who, prior to their surgery, ranked in the (upper 50th. percentile) vs. (lower 50th. percentile) healthcare utilizing tiers.
Time frame: one to two years postop
1 secondary outcome
Determine changes in the cost of obesity-related co-morbidities for all study participants and those who, prior to surgery, were within high or low healthcare utilizing tiers.
Time frame: At the end of postoperative year 1 and 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Background: PubMed 10889785Seidell JC. Obesity, insulin resistance and diabetes--a worldwide epidemic. Br J Nutr. 2000 Mar;83 Suppl 1:S5-8. doi: 10.1017/s000711450000088x.
- Background: PubMed 12365955Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.
- Background: PubMed 12365956Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002 Oct 9;288(14):1728-32. doi: 10.1001/jama.288.14.1728.
- Background: PubMed 12365960Freedman DS, Khan LK, Serdula MK, Galuska DA, Dietz WH. Trends and correlates of class 3 obesity in the United States from 1990 through 2000. JAMA. 2002 Oct 9;288(14):1758-61. doi: 10.1001/jama.288.14.1758.
- Background: PubMed 10546690Mokdad AH, Serdula MK, Dietz WH, Bowman BA, Marks JS, Koplan JP. The spread of the obesity epidemic in the United States, 1991-1998. JAMA. 1999 Oct 27;282(16):1519-22. doi: 10.1001/jama.282.16.1519.
- Background: PubMed 10511607Calle EE, Thun MJ, Petrelli JM, Rodriguez C, Heath CW Jr. Body-mass index and mortality in a prospective cohort of U.S. adults. N Engl J Med. 1999 Oct 7;341(15):1097-105. doi: 10.1056/NEJM199910073411501.
- Background: PubMed 7351764Drenick EJ, Bale GS, Seltzer F, Johnson DG. Excessive mortality and causes of death in morbidly obese men. JAMA. 1980 Feb 1;243(5):443-5.
- Background: PubMed 15652713McGee DL; Diverse Populations Collaboration. Body mass index and mortality: a meta-analysis based on person-level data from twenty-six observational studies. Ann Epidemiol. 2005 Feb;15(2):87-97. doi: 10.1016/j.annepidem.2004.05.012.
- Background: PubMed 1531097Sjostrom LV. Mortality of severely obese subjects. Am J Clin Nutr. 1992 Feb;55(2 Suppl):516S-523S. doi: 10.1093/ajcn/55.2.516s.
- Background: PubMed 15479938Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
- Background: PubMed 15809466Maggard MA, Shugarman LR, Suttorp M, Maglione M, Sugerman HJ, Livingston EH, Nguyen NT, Li Z, Mojica WA, Hilton L, Rhodes S, Morton SC, Shekelle PG. Meta-analysis: surgical treatment of obesity. Ann Intern Med. 2005 Apr 5;142(7):547-59. doi: 10.7326/0003-4819-142-7-200504050-00013.
- Background: PubMed 15319713Christou NV, Sampalis JS, Liberman M, Look D, Auger S, McLean AP, MacLean LD. Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients. Ann Surg. 2004 Sep;240(3):416-23; discussion 423-4. doi: 10.1097/01.sla.0000137343.63376.19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith C Kim, MD principal investigator
Advanced Minimally Invasive and Bariatric Surgery Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in FHHS expenses pertaining to medical costs incurred by all study participants, as well as those study participants who, prior to their surgery, ranked in the (upper 50th. percentile) vs. (lower 50th. percentile) healthcare utilizing tiers. (time frame: one to two years postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02381704, which also lists 45 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.