Improving Diabetes in Primary Care (IMPACT)

Tracking Information
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: 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	Observational
Study Design	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition	Diabetes Mellitus; Type 2 Diabetes Mellitus; Hypertension
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.
Recruitment Information
Recruitment Status	Completed
Enrollment; (submitted: June 23, 2005)	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); 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
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Kevin A Peterson, MD MPH University of Minnesota - Clinical and Translational Science Institute
PRS Account	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	March 2010