Patient Provider Partnership: Improving Diabetes Care in the Community
| Tracking Information | |||||
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| First Received Date ICMJE | September 9, 2005 | ||||
| Last Updated Date | September 9, 2005 | ||||
| Start Date ICMJE | October 2001 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| 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 | Patient Provider Partnership: Improving Diabetes Care in the Community | ||||
| Official Title ICMJE | Patient Provider Partnership: Improving Diabetes Care in the Community | ||||
| Brief Summary | With the advent of managed care, increasing responsibility for the care of patients with diabetes is being placed on primary care physicians. Evidence exists that physicians are not meeting established practice guidelines, and outcomes in patients with diabetes are less than optimal. It is thus the objective of this study to institute a community-based diabetes education intervention for both physicians and patients to enhance adherence to guidelines and improve patient outcomes. We will conduct a chart review (submitted under a separate IRB: #000733) in primary care practices to determine health status and guideline adherence. Following the chart review, physician practices will be assigned to one of three groups: physician + patient education, physician education alone, and usual care. Following the intervention, a repeat chart review will be conducted. Pre and posttest comparisons will be conducted to examine changes primarily in glycemic control, quality of life, patient knowledge, and physician adherence to practice guidelines. Secondarily, we will examine changes in therapeutic intervention, body mass index, and barriers to diabetes care. We will also examine individual barriers to diabetes care and their influence on outcomes in this population. The last phase of the study will encompass a second follow-up visit in which we will examine behavioral factors related to clinical change and sustainability of the intervention. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training |
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| Condition ICMJE | Diabetes | ||||
| Intervention ICMJE | Behavioral: physician and patient education; physician practice redesign | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 270 | ||||
| Completion Date | February 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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 | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00167284 | ||||
| Other Study ID Numbers ICMJE | 010157 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||
| Verification Date | September 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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