title: Effectiveness and feasibility of a software tool to help patients communicate with doctors about problems they face with their medication regimen (EMPATHy): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Low-income, Mexican-American patients with diabetes exhibit high rates of medication nonadherence, 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, 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. The primary objective of this project is to pilot test a prototype software toolkit called "EMPATHy" that a community health worker can administer to help patients identify the most important barriers to adherence that they face and discuss these barriers with their doctor.
  
  
  METHODS
  The EMPATHy toolkit will be piloted in an ongoing intervention (Coached Care) in which community health workers 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. A total of 190 Mexican-American patients with poorly controlled type 2 diabetes will be recruited from December 2014 through June 2015 and will be randomly assigned to complete either a single Coached Care intervention visit with no software tools or a Coached Care visit incorporating the EMPATHy software toolkit. The primary endpoints are (1) the development of a "contextualized plan of care" (i.e., a plan of care that addresses a barrier to medication adherence in the patient's daily life) with the doctor, determined from an audio recording of the medical visit, and (2) attainment of a concrete behavioral goal set during the intervention session, assessed in a 2-week follow-up phone call to the patient. The statistical analysis will include logistic regression models and is powered to detect a 50% increase in the primary endpoints.
  
  
  CONCLUSIONS
  The study will provide evidence regarding the effectiveness and feasibility of a software tool to help patients communicate with doctors about problems they face with their medications.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02324036 Registered 16 December 2014.
authors: Health Policy Research Institute and Division of General Internal Medicine, School of Medicine, University of California, Irvine, 100 Theory, Suite 110, Irvine, CA, 92697, USA. jbillime@uci.edu.
authors: John
authors: J
authors: Billimek
authors: Health Policy Research Institute and Division of General Internal Medicine, School of Medicine, University of California, Irvine, 100 Theory, Suite 110, Irvine, CA, 92697, USA. hguzman@uci.edu.
authors: Herlinda
authors: H
authors: Guzman
authors: Department of Family Medicine, School of Medicine, University of California, Irvine, 101 The City Drive South, Building 200, Suite 835, Orange, CA, 92868, USA. mangulo@uci.edu.
authors: Marco A
authors: MA
authors: Angulo
mesh_terms: D001291:Attitude of Health Personnel; D002140:California / Q000453:epidemiology; D003142:Communication; D003150:Community Health Workers; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology; D004359:Drug Therapy, Combination; D004645:Empathy; D005240:Feasibility Studies; D005260:Female; D007722:Health Knowledge, Attitudes, Practice / Q000208:ethnology; D054624:Health Status Disparities; D054625:Healthcare Disparities / Q000208:ethnology; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D055118:Medication Adherence / Q000208:ethnology; D017058:Mexican Americans / Q000523:psychology*; D010348:Patient Care Team; D010353:Patient Education as Topic; D010817:Physician-Patient Relations; D010865:Pilot Projects; D012107:Research Design; D012307:Risk Factors; D012985:Software Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents