Regimen Education and Messaging in Diabetes (REMinD)

NCT03185741 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 767

Last updated 2023-03-10

Study results available
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Summary

The investigators will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. The UMS standardizes the prescribing and dispensing of medicine by using health literacy principles and more explicit times to describe when to take medicine (morning, noon, evening, bedtime). This eliminates variability found in the way prescriptions are written by physicians and transcribed by pharmacists onto drug bottle labels. The proposed intervention will standardize prescribing within an electronic health record (EHR) so all medication orders include UMS prescription instructions ('sigs') and patients receive a medication information sheet with their after-visit summaries. Additionally, to help patients remember when to take prescribed medicines we will link unidirectional short message service (SMS) text reminders to the EHR, delivering medication reminders to patients around UMS intervals.

1. Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care.
2. Determine if the effects of these UMS strategies vary by patients' literacy skills and language.
3. Using mixed methods, evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the interventions.
4. Assess the costs required to deliver either intervention from a health system perspective.

Conditions

  • Diabetes Mellitus, Type 2
  • Medication Adherence

Interventions

BEHAVIORAL

UMS Strategy

Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.

BEHAVIORAL

SMS Text Messaging

Patients will receive daily text message reminders about when to take medicines based on UMS intervals.

Sponsors & Collaborators

Principal Investigators

  • Michael Wolf, PhD MPH · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-05
Primary Completion
2022-02-02
Completion
2022-11-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03185741 on ClinicalTrials.gov