PEIDiC Patient Empowerment to Improve Diabetes Care For Type 2 (adult-onset) Diabetics Principal Investigator: Catherine Barnes, PhD, MA, MSN Sponsor: American Diabetes Association

Purpose

Our present management of diabetes is limited because of inadequate engagement of the patient. In the Grady Health System (GHS), a large urban municipal hospital system in Atlanta, Georgia, our NIH-sponsored research has shown that programs aimed at overcoming provider "clinical inertia"1 - failure to initiate or advance therapy appropriately when clinically indicated - can improve both blood pressure and HbA1c outcomes. Residual limitations in reaching American Diabetes Association (ADA) goals appear to be due largely to lack of patient engagement, and this appears to be a particular problem for racial/ethnic minority populations who suffer disparities in health - such as the population at Grady, which is largely African-American, and poor and/or uninsured. Although patient-focused diabetes education programs have in the past produced improvements in patient knowledge and self-monitoring of glucose levels, there has been less success in improving A1c levels. A1c levels are especially high in patients treated with insulin, which likely is due to a focus on educational process rather than on reaching ADA targets; we believe that knowledge and skills alone will be insufficient, and that to be effective, educational programs must also overcome barriers such as lack of confidence and experience in setting goals, and in collaborating with providers. We seek an opportunity to test a new strategy for patients who require insulin therapy. This strategy is based on our experience in improving outcomes in this population; we believe that empowering the patient to interact with the provider - to push together to use medication and lifestyle modification in concert - is essential to achieve ADA goals. We will test the impact of this new strategy in a randomized, controlled, trial, as outlined below.

Duration of Study

3 years (July 2005 to July 2008)

Eligibility Criteria

A1c > 7 and taking insulin

How this study will be conducted

• To determine whether patient empowerment and knowledge are improved by the PEIDiC intervention, we will conduct a randomized, controlled trial in the Grady Diabetes Clinic, and assess endpoints at 6 and 12 months with well-validated questionnaires [Patient Empowerment Scale Short Form (DES_SF) and Patient Explanatory Model: Type 2], comparing patients receiving the active intervention (one-on-one coaching and an individualized, visit and patient-specific diabetes "roadmap") with controls who receive routine education classes; the clinic "process" for intervention and control subjects will be identical except for the PEIDiC intervention at each visit.
  
  
• To determine whether clinically significant diabetes outcomes are improved by the PEIDiC intervention, our randomized, controlled trial will assess endpoints at 6 and 12 months as (a) a primary outcome of major clinical importance - levels of A1c, and (b) "mechanistic" secondary outcomes which may contribute to changes in A1c - (i) patient adherence (taking medications as recommended and keeping scheduled appointments), and (ii) provider adherence (frequency and amount of intensification of therapy).

Other faculty and staff involved in this study (Where available, click on a name for more information.)

• David Ziemer, MD , Co-Principal Investigator
• Molly Meinbresse, MPH , Research interviewer
• Bretia Arrington , Research interviewer