Regimen Education and Messaging in Diabetes (REMinD)



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - Any
Updated:12/23/2018
Start Date:January 5, 2018
End Date:July 31, 2021
Contact:Michael Wolf, PhD MPH
Email:mswolf@northwestern.edu
Phone:312.503.5592

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
2
sites
303 East Superior Street
Chicago, Illinois 60611
Phone: 312-503-3272
?
mi
from
Chicago, IL
Click here to add this to my saved trials
New York, New York 10029
Phone: 212-824-7727
?
mi
from
New York, NY
Click here to add this to my saved trials