Improving Diabetes in Primary Care (IMPACT)
Condition: Diabetes Mellitus; Type 2 Diabetes Mellitus; Hypertension
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

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:

        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.
    

Intervention name(s): TRANSLATE
Intervention type(s): Behavioral
Time perspective: Prospective
Keywords: Clinical trial; Diabetes; Quality Improvement