Evidence map›Paper›PMID 25873349›Full record

Trial reportTrials2015

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.

John Billimek, Herlinda Guzman, Marco A Angulo

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02324036 (The EMPATHy Toolkit), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02324036 early_phase1completednot on this map

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

TypeinterventionalSponsorUniversity of California, IrvineRan2014 to 2015Enrolled190ConditionsDiabetes Mellitus, Type 2ArmsEMPATHy Toolkit, Coached Care
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Bridging Gaps and Understanding Disparities in Gestational Diabetes Mellitus to Improve Perinatal Outcomes.Diabetes spectrum : a publication of the American Diabetes Association · 2019
    Article
  3. Article
  4. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

John BillimekHealth 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.
Herlinda GuzmanHealth 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.
Marco A AnguloDepartment 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.
University of California, Irvine · USUniversity of California, Berkeley · US

Funding

University of California Health Participation in the National COVID Cohort Collaborative (N3C)UL1TR001414 · NCATS · UNIVERSITY OF CALIFORNIA-IRVINE · PI COOPER, DAN M, VILAIN, ERIC J. · 2015 to 2023
$35.1M
Institute for Clinical and Translational ScienceUL1TR000153 · NCATS · UNIVERSITY OF CALIFORNIA-IRVINE · PI COOPER, DAN M · 2012 to 2015
$12.1M
NCATS NIH HHS UL1 TR000153NCATS NIH HHS UL1 TR001414
6 · The paper itself

Abstract

backgroundLow-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/

designThe 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. DISCUSSION: 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.

trial registrationClinicalTrials.gov NCT02324036 Registered 16 December 2014.

Indexed as

CommunicationCommunity Health WorkersHealth Knowledge, Attitudes, PracticeMedication AdherencePhysician-Patient RelationsSoftware DesignAttitude of Health PersonnelCaliforniaDiabetes Mellitus, Type 2Drug Therapy, CombinationEmpathyFeasibility StudiesFemaleHealthcare DisparitiesHealth Status DisparitiesHumansHypoglycemic Agents

Identifiers

PMID25873349
PMCPMC4409752
OpenAlexW1964391671

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.