search
Back to results

Regimen Education and Messaging in Diabetes (REMinD)

Primary Purpose

Diabetes Mellitus, Type 2, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UMS Strategy
SMS Text Messaging
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University
  • Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

UMS Strategy

UMS Strategy + SMS Text Messaging

Usual Care

Arm Description

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.

In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.

Patients of providers randomized to the usual care arm will receive their standard care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
Treatment Knowledge
Identification of drug purpose

Full Information

First Posted
June 8, 2017
Last Updated
February 9, 2023
Sponsor
Northwestern University
Collaborators
Icahn School of Medicine at Mount Sinai, Emory University, Northwestern Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03185741
Brief Title
Regimen Education and Messaging in Diabetes (REMinD)
Official Title
EHR-based Universal Medication Schedule to Improve Adherence to Complex Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
February 2, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Icahn School of Medicine at Mount Sinai, Emory University, Northwestern Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Medication Adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
767 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UMS Strategy
Arm Type
Experimental
Arm Description
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.
Arm Title
UMS Strategy + SMS Text Messaging
Arm Type
Experimental
Arm Description
In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients of providers randomized to the usual care arm will receive their standard care
Intervention Type
Behavioral
Intervention Name(s)
UMS Strategy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SMS Text Messaging
Intervention Description
Patients will receive daily text message reminders about when to take medicines based on UMS intervals.
Primary Outcome Measure Information:
Title
Medication Adherence: Pill Count
Description
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.
Time Frame
6 months after baseline
Secondary Outcome Measure Information:
Title
Medication Adherence: 24-hour Recall
Description
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
Time Frame
6 months after baseline
Title
Medication Adherence: ASK-12
Description
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.
Time Frame
6 months after baseline
Title
Treatment Knowledge
Description
Identification of drug purpose
Time Frame
6 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wolf, PhD MPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Regimen Education and Messaging in Diabetes (REMinD)

We'll reach out to this number within 24 hrs