Study Results
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View full resultsBasic Information
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COMPLETED
NA
767 participants
INTERVENTIONAL
2018-01-05
2022-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
1. 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.
2. Single-page, plain language medication information sheets with important medication-related information following health literacy best practices.
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.
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.
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.
Usual Care
Patients of providers randomized to the usual care arm will receive their standard care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Emory University
OTHER
Northwestern Memorial Hospital
OTHER
Northwestern University
OTHER
Responsible Party
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Michael S. Wolf
Professor
Principal Investigators
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Michael Wolf, PhD MPH
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Mount Sinai School of Medicine
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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