Clinical trial NCT03185741: Regimen Education and Messaging in Diabetes (REMinD)
Official title: EHR-based Universal Medication Schedule to Improve Adherence to Complex Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Medication Adherence
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: Emory University
name: Northwestern Memorial Hospital
First posted: 2017-06-14
Enrollment: 767
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication Adherence: Pill Count
timeFrame: 6 months after baseline
Secondary outcomes:
measure: Medication Adherence: 24-hour Recall
timeFrame: 6 months after baseline
measure: Medication Adherence: ASK-12
timeFrame: 6 months after baseline
measure: Treatment Knowledge
timeFrame: 6 months after baseline
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Northwestern University
name: Michael Wolf, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: