Improving Diabetes in Primary Care (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00108927
Recruitment Status : Completed
First Posted : April 21, 2005
Last Update Posted : March 2, 2010
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Condition or disease Intervention/treatment
Diabetes Mellitus Type 2 Diabetes Mellitus Hypertension Behavioral: TRANSLATE

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:

  1. the change in A1c and systolic blood pressure values among all patients with diagnosed diabetes mellitus in participating primary care clinics over 12 months;
  2. 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;
  3. 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 : Observational
Enrollment : 6000 participants
Time Perspective: Prospective
Official Title: Improving Diabetes Through Primary Care Translation (IMPACT)
Study Start Date : December 2003
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00108927

United States, Minnesota
Dept of Family Medicine and Community Health, University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Kevin A Peterson, MD MPH University of Minnesota - Clinical and Translational Science Institute

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00108927     History of Changes
Other Study ID Numbers: 1 R18 DK061709 (completed)
First Posted: April 21, 2005    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: March 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Clinical trial
Quality Improvement

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases