Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-02-24 @ 10:22 PM
Study NCT ID:
NCT02364128
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2015-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Patient Decisions About Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-25', 'studyFirstSubmitDate': '2015-01-22', 'studyFirstSubmitQcDate': '2015-02-13', 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decision outcome by Decider Guider Questionnaire', 'timeFrame': '24 months', 'description': 'Decisional measures'}, {'measure': 'Patient specific outcome by Decider Guider Questionnaire', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Knowledge, as measured by a follow-up Decider Guider questionnaire to test knowledge', 'timeFrame': '24 months'}, {'measure': 'Preferences as measured by Decider Guider Questionnaire', 'timeFrame': '24 months'}, {'measure': 'Weight', 'timeFrame': '24 months'}, {'measure': 'Quality of Life as measured by Decider Guider Questionnaire', 'timeFrame': '24 months'}, {'measure': 'Comorbidity Resolution as measured by Decider Guider Questionnaire', 'timeFrame': '24 months'}, {'measure': 'Patient Satisfaction as measured by Decider Guider Questionnaire', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Morbid Obesity', 'Weight Reduction']}, 'descriptionModule': {'briefSummary': "At least 15 million Americans are morbidly obese, or more than 100 pounds overweight. Medical treatments including drugs and behavior modification have proven ineffective in producing significant and lasting weight loss in this group. While bariatric surgery is extremely effective for most patients, it also carries risks for both short and long-term complications. There are currently four different types of bariatric surgery available and the risks and benefits of these procedures vary widely and are strongly affected by patient and clinical characteristics.\n\nDecision making under these circumstances should reflect informed patient's values and preferences regarding these trade-offs. Instead, the choice of bariatric procedure is more often driven by the beliefs and experiences of the bariatric surgeon that a patient happens to see. Variability in the type of surgery recommended to patients likely results from some combination of surgeons' subjective opinions and personal experiences with regard to the risks and benefits of the treatment options and delegated decision making on the part of patients.\n\nThe goals of this research proposal are to develop, implement, and evaluate an informed decision support tool for treatment of morbid obesity. This project will be conducted within the context of the Michigan Bariatric Surgery Collaborative (MBSC), which is a statewide clinical registry and quality improvement program that has the participation of virtually every bariatric surgeon and program in the state of Michigan. The MBSC registry now includes externally audited clinical data for more than 80,000 consecutive bariatric surgery patients. MBSC outcome measures include complications occurring within 30 days as well as weight loss, comorbidity resolution, quality of life and satisfaction at 1, 2, and 3 years after bariatric surgery.", 'detailedDescription': 'Our specific aims are:\n\n1. To develop a web-based interactive decision support tool to incorporate tailored information regarding risks and benefits of the treatment options (from regression-based prediction models derived on the 35,000 patients already in the MBSC registry) with information regarding other salient attributes of the treatment options (derived from focus groups and semi-structured interviews with stakeholders including bariatric surgery patients, bariatric program staff, and surgeons).\n2. To perform a quasi-experimental study comparing the decision support tool with usual care to determine its effects on patient decisions (treatment choice, knowledge, treatment-preference concordance, and decisional conflict) and on patient outcomes including weight loss, patient satisfaction, and improvements in quality of life after surgery.\n\nThis research is closely aligned with the goals of PCORI and will have direct impacts on patients and caregivers by providing information that is required to improve healthcare decision-making for this prevalent, damaging, and costly condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients considering undergoing bariatric surgery in the state of Michigan who are 18 or older.\n* All patients, regardless of gender or racial/ethnic background, will be recruited to participate in the study in the same way.\n\nExclusion Criteria:\n\n* Patients under the age of 18'}, 'identificationModule': {'nctId': 'NCT02364128', 'acronym': 'PCORI', 'briefTitle': 'Improving Patient Decisions About Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Patient-Centered Outcomes Research Institute (PCORI)- Improving Patient Decisions About Bariatric Surgery', 'orgStudyIdInfo': {'id': 'HUM00083670'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Potential bariatric surgery patients who receive both the baseline questionnaire and follow-up questionnaire.'}, {'type': 'OTHER', 'label': 'Decision Aid', 'description': 'Potential bariatric surgery patients who receive both the baseline questionnaire decision aid/conjoint analysis and follow-up questionnaire.', 'interventionNames': ['Behavioral: Decider Guider: Weight Loss']}], 'interventions': [{'name': 'Decider Guider: Weight Loss', 'type': 'BEHAVIORAL', 'description': 'Decision aid tool about weight loss treatment', 'armGroupLabels': ['Decision Aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Amir Ghaferi', 'investigatorAffiliation': 'University of Michigan'}}}}