Improving Diabetes in Primary Care (IMPACT)
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ClinicalTrials.gov Identifier: NCT00108927 |
Recruitment Status
:
Completed
First Posted
: April 21, 2005
Last Update Posted
: March 2, 2010
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Tracking Information | ||||
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First Submitted Date | April 20, 2005 | |||
First Posted Date | April 21, 2005 | |||
Last Update Posted Date | March 2, 2010 | |||
Study Start Date | December 2003 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures | Not Provided | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT00108927 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Improving Diabetes in Primary Care (IMPACT) | |||
Official Title | Improving Diabetes Through Primary Care Translation (IMPACT) | |||
Brief Summary | The goal of our research program is to successfully translate empirical knowledge regarding diabetes treatment and management into sustainable clinical practice. The study hypothesis is that implementation of a multicomponent intervention will result in meaningful improvement in clinical performance measures at the clinic that include average A1c (Hemoglobin A1c), average systolic blood pressure, and national clinical performance measures at a reasonable cost to the health system. | |||
Detailed Description | The focus of the study is on the primary care environment, where the majority of patients with diabetes seek on-going health care. The proposed group-randomized and controlled clinical trial-targeted at 24 primary care clinics-evaluates the effectiveness of the TRANSLATE intervention, a multifaceted diabetes intervention program promoting better comprehensive diabetes management. The intervention begins by evaluating the organizational structures of primary care offices and identifying existing barriers in these small complex systems. A set of nine well-developed intervention components-selected from among some of the most successful strategies in the literature for altering clinical outcomes-are then introduced to correct existing deficiencies at each clinic. The TRANSLATE components function as an interdependent system, providing substantial support to both the provider and patient. Key features include the targeting of high-risk patients, a patient reminder system for routine visits, both passive and patient-specific physician reminders, a disease-specific networked reporting system, and physician education. Implementation is facilitated by a local diabetes intervention team assisted by a site coordinator and a local physician champion. Notably, the model does not centralize care, but rather promotes dissemination of care delivery improvements by promoting infrastructure changes at the primary care clinic where most care is delivered. Quality improvement methods are employed to optimize implementation in each unique clinic setting. Upper level administrative personnel are integrated into the regular review of implementation measures and resource use. The study hypothesis is that implementation of the TRANSLATE intervention will result in meaningful improvement in physiologic outcome measures and important disease process measures-at a reasonable cost-within primary care settings. The specific aims of the project are to rigorously evaluate the effectiveness of the TRANSLATE program by comparing intervention and control clinics on the following three clinical and economic outcomes:
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Study Type | Observational | |||
Study Design | Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Not Provided | |||
Study Population | Not Provided | |||
Condition |
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Intervention | Behavioral: TRANSLATE | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Peterson KA, Radosevich DM, O'Connor PJ, Nyman JA, Prineas RJ, Smith SA, Arneson TJ, Corbett VA, Weinhandl JC, Lange CJ, Hannan PJ. Improving Diabetes Care in Practice: findings from the TRANSLATE trial. Diabetes Care. 2008 Dec;31(12):2238-43. doi: 10.2337/dc08-2034. Epub 2008 Sep 22. | |||
* 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 | Completed | |||
Enrollment |
6000 | |||
Original Enrollment | Same as current | |||
Study Completion Date | December 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria | Inclusion Criteria: (The unit of randomization is the medical clinic)
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Sex/Gender |
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Ages | 18 Years to 90 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00108927 | |||
Other Study ID Numbers | 1 R18 DK061709 (completed) | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||
Verification Date | March 2010 |