- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00108927
Improving Diabetes in Primary Care (IMPACT)
Improving Diabetes Through Primary Care Translation (IMPACT)
Study Overview
Status
Intervention / Treatment
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:
- the change in A1c and systolic blood pressure values among all patients with diagnosed diabetes mellitus in participating primary care clinics over 12 months;
- the quality of diabetes care delivery as measured by the distribution and prevalence of appropriate A1c, microalbumin, low density lipoprotein measurements, and foot exams over 12 months;
- the economic impact on the health care delivery system as measured by the short- and long-term cost from the perspective of the health care system.
Study Type
Enrollment
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55414
- Dept of Family Medicine and Community Health, University of Minnesota Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
(The unit of randomization is the medical clinic)
- Clinics were excluded if they participated in an effective quality improvement program within the last two years.
- Clinics must have 3-22 full time equivalent providers
- Clinics must be located in Minnesota or Western Wisconsin
- Clinics must be willing to implement a diabetes registry
- Must be a single specialty, general internal medicine or family practice clinic
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
Collaborators and Investigators
Investigators
- Principal Investigator: Kevin A Peterson, MD MPH, University of Minnesota
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 R18 DK061709 (completed)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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