Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT00262704
Status:
COMPLETED
Last Update Posted:
2014-08-21
First Post:
2005-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SimCare: Physician Intervention to Improve Diabetes Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2020}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2002-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-20', 'studyFirstSubmitDate': '2005-12-06', 'studyFirstSubmitQcDate': '2005-12-06', 'lastUpdatePostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glycemic control', 'timeFrame': 'All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians', 'description': 'Glycosylated hemoglobin (A1c) values and A1c test rates were used to assess glycemic control.'}, {'measure': 'lipid control', 'timeFrame': 'All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians', 'description': 'LDL-cholesterol levels and test rates were used to assess lipid control.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['physician intervention', 'diabetes mellitus', 'primary care', 'quality improvement', 'disease management'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '21249838', 'type': 'BACKGROUND', 'citation': "O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA, Biltz G. Clinical Inertia and Outpatient Medical Errors. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 2: Concepts and Methodology). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20513/"}, {'type': 'BACKGROUND', 'citation': "Dutta P, Biltz GR, Johnson PE, Sperl-Hillen JM, Rush WA, Duncan JE, O'Connor PJ. SimCare: A Simulation Model to Investigate Physician Decision-Making in the Care of Patients with Type 2 Diabetes. In K. Henriksen, J. Battles, D. Lewin, and E. Marks. Advances in Patient Safety: From Research to Implementation. Rockville, MD. Agency for Healthcare Research and Quality (AHRQ). 2005; Vol.4: Programs, Tools, and Products; 179-192. <http://www.ahrq.gov/qual/advances/>"}, {'pmid': '21249801', 'type': 'BACKGROUND', 'citation': "O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA. Identification, Classification, and Frequency of Medical Errors in Outpatient Diabetes Care. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 1: Research Findings). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK20464/"}, {'pmid': '14662620', 'type': 'BACKGROUND', 'citation': "O'Connor PJ. Overcome clinical inertia to control systolic blood pressure. Arch Intern Med. 2003 Dec 8-22;163(22):2677-8. doi: 10.1001/archinte.163.22.2677. No abstract available."}, {'pmid': '12930043', 'type': 'BACKGROUND', 'citation': "O'Connor PJ. Setting evidence-based priorities for diabetes care improvement. Int J Qual Health Care. 2003 Aug;15(4):283-5. doi: 10.1093/intqhc/mzg062. No abstract available."}, {'pmid': '12363045', 'type': 'BACKGROUND', 'citation': "Johnson PE, Veazie PJ, Kochevar L, O'Connor PJ, Potthoff SJ, Verma D, Dutta P. Understanding variation in chronic disease outcomes. Health Care Manag Sci. 2002 Aug;5(3):175-89. doi: 10.1023/a:1019740401536."}, {'pmid': '12150470', 'type': 'BACKGROUND', 'citation': "O'Connor PJ. Patient archetypes, physician archetypes, and tailored diabetes care. J Am Board Fam Pract. 2002 Jul-Aug;15(4):334-7. No abstract available."}, {'pmid': '19171723', 'type': 'RESULT', 'citation': "O'Connor PJ, Sperl-Hillen JM, Johnson PE, Rush WA, Asche SE, Dutta P, Biltz GR. Simulated physician learning intervention to improve safety and quality of diabetes care: a randomized trial. Diabetes Care. 2009 Apr;32(4):585-90. doi: 10.2337/dc08-0944. Epub 2009 Jan 26."}]}, 'descriptionModule': {'briefSummary': 'This randomized trial will test the hypotheses that (a) a physician opinion leader intervention, (b) a "narrative process trace" physician feedback intervention, or (c) the combined intervention (a + b), are no more effective than (d) usual care in improving the clinical care of adult patients with type 2 diabetes.', 'detailedDescription': 'This randomized trial will test the hypothesis that (a) an influential physician feedback intervention, (b) a "narrative process trace" feedback intervention, or (c) the combined intervention (a + b), are no more effective than (d) usual care in improving the clinical care of adult patients with diabetes mellitus.\n\nThe unit of randomization and the unit of analysis will be primary care physicians who have more than 10 adult patients with diabetes mellitus. The 162 physicians eligible for this study provide care to about 6,804 adults with diagnosed diabetes at 24 primary care clinics. The narrative process trace intervention uses automated medical record (AMR)-mounted clinical cases to assess physicians\' diabetes care decisions, with results provided as feedback to physicians. The influential physician feedback intervention emphasizes individualized education of physicians, which will be guided by the narrative process trace in the combined intervention group. Usual care includes the use of a diabetes clinical guideline, use of a diabetes patient registry that provides key clinical data for each adult patient with diabetes, and access to clinic-based diabetes education nurses. We have shown in previous controlled studies that the guideline, diabetes registry, and clinic-based diabetes education nurses have failed to significantly improve diabetes care on a population basis, thus justifying the additional, stronger interventions that now will be tested.\n\nDependent variables include glycemic control and cardiovascular risk reduction of all 3,360 patients cared for by the 80 study physicians. Secondary analysis will assess rates of screening for microvascular complications. Physicians will be randomized in blocks based on specialty, number of diabetes patients, and years of practice experience. Hierarchical data analysis will be used to accommodate the nested data and propensity scores will be used to correct for selection effects and missing data. Results of this experiment will advance our theoretical understanding of physician behavior change and quantify cost and impact of three specific intervention strategies to improve chronic disease care in the primary care setting. The study will have substantial impact on clinical practice and policy whether the results are positive or negative. If successful, the interventions will be easily disseminated to other primary care practice settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients- Diabetes patients associated with the n=57 physicians were selected according to the following criteria: (1) enrolled in HealthPartners on January 1, 1998, (2) be at least 19 years of age on January 1, 1998, (3) have an established diagnosis of diabetes mellitus in 1998 based on meeting at least one of the following two criteria: (a) have one or more inpatient, or two or more outpatient International Classification of Diseases-9 (ICD-9) diagnostic codes 250.xx for diabetes, or (b) have a filled prescription for a diabetes-specific drug including insulins, sulphonylureas, biguanides, alpha-glucosidase inhibitors, thiazolidinediones, or meglitinides.\n* Physicians-All primary care adult care physicians (family physicians or primary care internists) employed full-time at HealthPartners medical groups as of 2000 were eligible for this study.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00262704', 'briefTitle': 'SimCare: Physician Intervention to Improve Diabetes Care', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'SimCare: Physician Intervention to Improve Diabetes Care', 'orgStudyIdInfo': {'id': '0001600'}, 'secondaryIdInfos': [{'id': 'R01HS010639', 'link': 'https://reporter.nih.gov/quickSearch/R01HS010639', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group A', 'description': 'Control group'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Simulated case-based customized learning', 'interventionNames': ['Behavioral: Simulated case-based customized learning']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Simulated case based customized learning + leader feedback', 'interventionNames': ['Behavioral: Simulated case based customized learning + leader feedback']}], 'interventions': [{'name': 'Simulated case-based customized learning', 'type': 'BEHAVIORAL', 'description': 'Formal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback', 'armGroupLabels': ['Group B']}, {'name': 'Simulated case based customized learning + leader feedback', 'type': 'BEHAVIORAL', 'description': "Formal Analysis of Diabetes Practice Style, Using SimCare cases with Process Trace Feedback + Physician Opinion Leader Feedback Tailored to Provider's Specific Practice Style", 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55440', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Research Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': "Patrick J O'Connor, MD MPH", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthPartners Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}