Viewing Study NCT00262704



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Last Modification Date: 2024-10-26 @ 9:21 AM
Study NCT ID: NCT00262704
Status: COMPLETED
Last Update Posted: 2014-08-21
First Post: 2005-12-06

Brief Title: SimCare Physician Intervention to Improve Diabetes Care
Sponsor: HealthPartners Institute
Organization: HealthPartners Institute

Study Overview

Official Title: SimCare Physician Intervention to Improve Diabetes Care
Status: COMPLETED
Status Verified Date: 2014-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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

The 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 6804 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

Dependent variables include glycemic control and cardiovascular risk reduction of all 3360 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HS010639 AHRQ None httpsreporternihgovquickSearchR01HS010639