Skip to main content
OpenTrials
Completed

NCT Number: NCT03185741

Regimen Education and Messaging in Diabetes (REMinD)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Medication Adherence Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

Loading trial locations.

About this study

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.

The investigators will conduct a 3-arm, multi-site trial to test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care. The investigators will enroll a total of 900 English and Spanish-speaking patients with poorly controlled type 2 diabetes mellitus. Enrolled patients will complete follow-up interviews 3 and 6 months following their baseline interview.

The aims of the investigation are to:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes mellitus diagnosis
  • Most recent hba1c value ≥7.5%.
  • Seek care at participating general internal medicine practices in Chicago or New York City.
  • English or Spanish speaking
  • Take 5 or more prescription drugs for chronic conditions (including 1 study medication)

Exclusion criteria

  • Severe uncorrectable vision or hearing impairment
  • Cognitive impairment (≥2 errors on a 6-item dementia screening tool or a chart-documented diagnosis of dementia)
  • Not primarily responsible for administering his/her medications
  • Does not own a cell phone that can receive text messages
  • Not comfortable receiving text messages

Treatment and study plan

UMS Strategy

Behavioral

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.

SMS text messaging

Behavioral

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

Primary outcomes

  1. Medication Adherence: Pill Count

    Time frame: 6 months after baseline

    Adherence will be measured for each prescription medication using an objective pill count of the number of pills within each prescription bottle. The proportion of pills taken over pills prescribed (PT/PP) will be calculated for each medication at baseline and 6Month. Pills taken will be calculated by subtracting the number of pills from the total quantity prescribed. Pills prescribed will be calculated by multiplying the number of pills prescribed each day by the number of days since the medication was filled. A proportion of pills taken over pills prescribed (PT/PP) of 80% or more is considered adherent.

Secondary outcomes

  1. Medication Adherence: 24-hour Recall

    Time frame: 6 months after baseline

    Adherence will be measured for each prescription medication using self-report of how many pills and how often each medicine was taken over the last 24 hours. Patients are asked to specify the amount taken (i.e. dose) and when taken (to determine frequency and interval between doses). A patient is considered adherent on a specific medication if they answered all correctly: 1.dose, 2.frequency, 3.interval between doses

  2. Medication Adherence: ASK-12

    Time frame: 6 months after baseline

    Adherence will be measured by the ASK-12 Adherence Barrier Survey, a subjective assessment of general adherence behaviors and barriers to treatment adherence.

    The ASK-12 is scored by summing the selected responses (with scores ranging from 12 to 60) with higher scores indicating greater barriers to adherence.

  3. Treatment Knowledge

    Time frame: 6 months after baseline

    Identification of drug purpose

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Emory University
  • Icahn School of Medicine at Mount Sinai
  • Northwestern Memorial Hospital

Registry information

Official study title

EHR-based Universal Medication Schedule to Improve Adherence to Complex Regimens

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2017
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.