Regimen Education and Messaging in Diabetes (REMinD)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185741
• Other study ID #: R01NR015444
• Status: Completed
• Phase: N/A
• Start date: January 5, 2018
• Est. completion date: November 30, 2022

Study information

• Verified date: February 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 767
• Est. completion date: November 30, 2022
• Est. primary completion date: February 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Medication Adherence

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	Emory University, Icahn School of Medicine at Mount Sinai, Northwestern Memorial Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Treatment Knowledge	Identification of drug purpose	6 months after baseline