Regimen Education and Messaging in Diabetes (REMinD)
Study Details
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.
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Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care.
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Determine if the effects of these UMS strategies vary by patients' literacy skills and language.
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Using mixed methods, evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the interventions.
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Assess the costs required to deliver either intervention from a health system perspective.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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:
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Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care.
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Determine if the effects of these UMS strategies vary by patients' literacy skills and language.
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Using mixed methods, evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the interventions.
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Assess the costs required to deliver either intervention from a health system perspective.
Study Design
Arms and Interventions
| 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.
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| 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.
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| No Intervention: Usual Care Patients of providers randomized to the usual care arm will receive their standard care |
Outcome Measures
Primary Outcome Measures
- Medication adherence: Pill Count [6 months after baseline]
Adherence will be measured for each prescription medication using an objective pill count of the number of pills within each prescription bottle.
Secondary Outcome Measures
- Medication adherence: 24-hour recall [6 months after baseline]
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
- Medication adherence: ASK-12 [6 months after baseline]
Adherence will be measured by the ASK-12 Adherence Barrier Survey, a subjective assessment of general adherence behaviors and barriers to treatment adherence.
- Treatment knowledge [6 months after baseline]
Identification of drug purpose
Eligibility Criteria
Criteria
Inclusion Criteria:
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Type 2 diabetes mellitus diagnosis
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Most recent hba1c value ≥7.5%.
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Seek care at participating general internal medicine practices in Chicago or New York City.
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English or Spanish speaking
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Take 5 or more prescription drugs for chronic conditions (including 1 study medication)
Exclusion Criteria:
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Severe uncorrectable vision or hearing impairment
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Cognitive impairment (≥2 errors on a 6-item dementia screening tool or a chart-documented diagnosis of dementia)
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Not primarily responsible for administering his/her medications
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Does not own a cell phone that can receive text messages
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Not comfortable receiving text messages
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 2 | Mount Sinai School of Medicine | New York | New York | United States | 10029 |
Sponsors and Collaborators
- Northwestern University
- Icahn School of Medicine at Mount Sinai
- Emory University
- Northwestern Memorial Hospital
Investigators
- Principal Investigator: Michael Wolf, PhD MPH, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01NR015444