Regimen Education and Messaging in Diabetes (REMinD)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Medication Adherence
• Intervention / Treatment: Behavioral: UMS Strategy; Behavioral: SMS Text Messaging

Detailed Description

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:

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.

• Study Type: Interventional
• Enrollment (Actual): 767
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. These materials will be generated within the electronic health record.; Prescription instructions will be adapted to the UMS format to establish four standard time intervals (morning, noon, evening, bedtime) for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.; Single-page, plain language medication information sheets with important medication-related information following health literacy best practices.	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.
Experimental: UMS Strategy + SMS Text Messaging; In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.	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.
No Intervention: Usual Care; Patients of providers randomized to the usual care arm will receive their standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence: Pill Count	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.	6 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence: 24-hour Recall	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	6 months after baseline
Medication Adherence: ASK-12	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.	6 months after baseline
Treatment Knowledge	Identification of drug purpose	6 months after baseline

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Icahn School of Medicine at Mount Sinai; Emory University; Northwestern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Actual): February 2, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: R01NR015444 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No