Clinical trial NCT02324036: The EMPATHy Toolkit: Helping Diabetes Patients Overcome Barriers to Medication Adherence
Official title: The EMPATHy Toolkit: Helping Diabetes Patients Overcome Barriers to Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients will be recruited from the University of California Irvine Federally Qualified Health Center family medicine clinic sites in Santa Ana and Anaheim with the following inclusion criteria:

  1. age 18 and older;
  2. have poorly controlled type 2 diabetes (as indicated by HbA1c\>7.5%, LDL cholesterol \>100 mg/dl or systolic blood pressure \> 140),
  3. be of Hispanic ethnicity,
  4. speak English or Spanish.

These data are available to the research team in an automated report emailed to the lead researcher every week in his role as coordinator of the routine care Coaching program. This report includes a list of upcoming appointments for patients who meet these inclusion criteria.

Primary outcomes:
measure: Development of a contextualized plan of care (assessed by analyzing an audio recording of the medical visit)
timeFrame: Baseline
measure: Attainment of concrete behavioral goal (assessed in a two-week follow-up phone call to the patient)
timeFrame: 2 weeks post visit
Secondary outcomes:
measure: Discussion of a contextual factor in the visit (assessed from audio recordings of the visit)
timeFrame: Baseline
measure: Improvement in "red flag" outcome (assessed from the patient's medical record as the change in the measured value of the outcome measure identified as a high priority outcome)
timeFrame: 6 months post visit
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Health Policy Research Institute
state: California
Study officials:
affiliation: Irvine
name: John Billimek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Billimek J, Guzman H, Angulo MA. 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. Trials. 2015 Apr 10;16:145. doi: 10.1186/s13063-015-0672-7.