The EMPATHy Toolkit: Helping Diabetes Patients Overcome Barriers to Medication Adherence

Diabetes Mellitus, Type 2 Clinical Trial

— EMPATHy  

Official title:

The EMPATHy Toolkit: Helping Diabetes Patients Overcome Barriers to Medication Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324036
• Other study ID #: 2014-1442
• Status: Completed
• Phase: Phase 0
• First received: December 16, 2014
• Last updated: November 30, 2015
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• EMPATHy Toolkit
Software-based toolkit to help patients identify and prioritize barriers to medication adherence; community health worker provides participation training to patient

Behavioral:
• Coached Care
Community health worker provides participation training to patient

Locations

Country	Name	City	State
United States	Health Policy Research Institute	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of a contextualized plan of care (assessed by analyzing an audio recording of the medical visit)	Development of a contextualized plan of care will be assessed by analyzing an audio recording of the medical visit, using a previously developed coding scheme (see Research Methodology). If the coder concludes that the plan of care discussed in the visit adequately addresses a contextual factor raised during the visit, it will be determined that a contextualized plan of care was developed.	Baseline	No
Primary	Attainment of concrete behavioral goal (assessed in a two-week follow-up phone call to the patient)	Attainment of concrete behavioral goal will be assessed in a two-week follow-up phone call to the patient, and will be defined as the patient reporting having completed the specific action that he or she specified with the Coach as a concrete goal during the intervention post-visit.	2 weeks post visit	No
Secondary	Discussion of a contextual factor in the visit (assessed from audio recordings of the visit)	Discussion of a contextual factor in the visit will be assessed from audio recordings of the visit using a previously developed coding scheme. If the coder concludes that a relevant barrier to the patient taking his or her medication consistently was raised during the visit, it will be determined that a contextual factor was discussed.	Baseline	No
Secondary	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)	Improvement in "red flag" outcome will be assessed from the patient's medical record as the change in the measured value of the outcome measure identified as a high priority outcome ("red flag") from intervention visit date till the next regularly scheduled assessment. The red flag outcome measure is selected by the Coach and patient during the intervention visit, and can be either hemoglobin A1c, LDL cholesterol or blood pressure level.	6 months post visit	No