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| Tracking Information | |||||
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| First Received Date ICMJE | March 14, 2001 | ||||
| Last Updated Date | August 6, 2009 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00012675 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Developing and Implementing a Quality Measure for Glycemic Control | ||||
| Official Title ICMJE | Developing and Implementing a Quality Measure for Glycemic Control | ||||
| Brief Summary | Many patients with diabetes are under sub-optimal glycemic control. Central to the clinician�s task in improving glycemic control is the management of hypoglycemic medication therapy, including the use of drugs such as insulin and sulfonylureas. Clinical trials have demonstrated that more intensive hypoglycemic medication therapy results in improved glycemic control. Yet quality measures for this critical process of care have not been developed and we know little about how physicians actually manage hypoglycemic medications. |
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| Detailed Description | Background: Many patients with diabetes are under sub-optimal glycemic control. Central to the clinician�s task in improving glycemic control is the management of hypoglycemic medication therapy, including the use of drugs such as insulin and sulfonylureas. Clinical trials have demonstrated that more intensive hypoglycemic medication therapy results in improved glycemic control. Yet quality measures for this critical process of care have not been developed and we know little about how physicians actually manage hypoglycemic medications. Objectives: We propose to develop a quality measure that describes the intensity of physicians� hypoglycemic medication therapy. We will then provide feedback to VA physicians regarding their practices and access to experts in diabetes care to determine whether this intervention leads to improvements in glycemic control. Methods: The study is divided into two phases. During the first phase we will use existing data to model the decision to increase hypoglycemic medications. At each medical visit, we will determine whether an increase in medication therapy occurred. We will use recursive partitioning to develop a model that identifies patient characteristics at the visit, such as recent laboratory results and diagnoses, associated with the decision to increase therapy. This model assigns a predicted probability of an increase in therapy to each visit. We then use these predictions to define an intensity of hypoglycemic medication therapy for each physician that compares the actual to predicted number of increases over all patient-visits. The second phase will be a randomized trial in which clinicians at experimental sites receive feedback on performance and access to expert opinion while usual care is provided at control sites. Feedback on performance will be provided twice over 6 months. The change in intensity of treatment scores and glycosylated hemoglobin levels pre- and post-intervention at these sites will be compared to performance of primary care physicians at control sites not receiving the intervention. Status: Project is ongoing. Phase 1 analyses have been completed. Clinicians have now received two rounds of feedback on their performance and we will be performing the final data collection shortly. One VA site unexpectedly dropped out after they decided to discontinue their research program. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Retrospective | ||||
| Condition ICMJE | Diabetes | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 0 | ||||
| Completion Date | December 2003 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Clinic patients with diabetes Exclusion Criteria: |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00012675 | ||||
| Responsible Party | Berlowitz, Dan - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | DII 99-205 | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | July 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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