The EMPATHy Toolkit: Helping Diabetes Patients Overcome Barriers to Medication Adherence
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The proposed study is a pilot study to gather data on the effectiveness and feasibility of a
      software tool (EMPATHy) to help patients communicate effectively with doctors about problems
      they face with their medication regimens. EMPATHy will be incorporated into an existing
      clinic-based intervention called Coached Care, in which community health workers (CHWs,
      non-professional community members) work as a "Coach" to patients to help them improve
      engagement and communication during the medical visit.
    

Detailed description: 
      Low income, Mexican American patients with diabetes exhibit high rates of medication
      nonadherence, which results in poor blood sugar control and serious complications, and often
      have difficulty communicating their concerns about the medication regimen to physicians.
      Interventions led by community health workers (CHWs), non-professional community members who
      are trained to work with patients to improve engagement and communication during the medical
      visit, have had mixed success in improving outcomes. Although CHWs possess excellent cultural
      competency and are very effective at establishing rapport with patients, they often lack a
      sophisticated understanding of all the potential challenges that can come with following a
      regimen. The primary objective of this project is to develop and pilot test a prototype
      software toolkit called "EMPATHy" that a CHW can administer to help patients identify and
      articulate the most important barriers to adherence that they face.

      The EMPATHy toolkit will be piloted in an ongoing intervention (Coached Care) in which CHWs
      are trained to be "Coaches" to meet with patients before the medical visit, and help them
      prepare a list of important questions for the doctor. The Lead Researcher (Billimek) is a
      co-director of this intervention program at UCI's Ambulatory Clinics, including the Family
      Health Center in Santa Ana ,with a highly vulnerable population-low income Mexican American
      patients with diabetes and a history of nonadherence. A CHW will be trained to use two
      commercially available software programs configured by the PI to deliver the intervention
      materials. Patients participating in Coached Care (which is a clinic- based intervention, not
      a research protocol) will be recruited to (1) complete a Coached Care intervention session
      that has been modified to incorporate the EMPATHy Toolkit, (2) answer questions about
      barriers to medication adherence and the feasibility/usability of the software (3) allow the
      research team to abstract data on the medication regimen and diabetes outcomes (hemoglobin
      A1c, LDL cholesterol, etc) from the patient's medical record.
    

Intervention name(s): EMPATHy Toolkit; Coached Care
Intervention type(s): Device; Behavioral
Intervention description(s): Software-based toolkit to help patients identify and prioritize barriers to medication adherence; community health worker provides participation training to patient; Community health worker provides participation training to patient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research