Improving Glycemic Control on GMS: A Quality Improvement Study
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | December 30, 2005 | ||||
| Last Updated Date | May 3, 2010 | ||||
| Start Date ICMJE | May 2010 | ||||
| Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00271700 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
- Quality of insulin orders using explicit criteria | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improving Glycemic Control on GMS: A Quality Improvement Study | ||||
| Official Title ICMJE | Improving Glycemic Control on GMS: A Quality Improvement Study | ||||
| Brief Summary | This study will examine whether new processes and technologies for monitoring diabetic patients' insulin levels improves patient care at Brigham and Women's Hospital. |
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| Detailed Description | This study will examine whether new processed and technologies for monitoring diabetic patients' insulin levels improves patient care. Patients at Brigham and Women's Hospital (BWH), staying on the General Medicine Service, who have Type 2 diabetes and who are not on IV insulin can participate in this study. Physicians and nurses will be taught new rules to care for diabetic patients, while in the hospital. Also, the BWH computer system will be updated to include these new rules for administering insulin. Patients who participate in the study will be randomly placed into one of two groups: one group that will be cared for by physicians and nurses who have learned these new rules for administering insulin; or the second group, who will receive diabetes care at BWH before the new rules were adopted. The study will last approximately 1 year. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE | Diabetes Mellitus | ||||
| Intervention ICMJE | Behavioral: Order Set, Education, Feedback | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 1100 | ||||
| Estimated Completion Date | March 2011 | ||||
| Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00271700 | ||||
| Other Study ID Numbers ICMJE | 2005-P-001880/1, 2005-P-001880/1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Jeffrey L. Schnipper, MD, MPH, Brigham & Women's Hospital | ||||
| Study Sponsor ICMJE | Brigham and Women's Hospital | ||||
| Collaborators ICMJE | Novo Nordisk | ||||
| Investigators ICMJE |
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| Information Provided By | Brigham and Women's Hospital | ||||
| Verification Date | May 2010 | ||||
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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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