NCT03185741

Regimen Education and Messaging in Diabetes (REMinD)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 767 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2
• Medication Adherence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-05
• Primary completion: 2022-02-02
• Completion: 2022-11-30
• First posted: 2017-06-14
• Last updated: 2023-03-10
• Results posted: 2023-03-10

Locations

2 sites across 1 country: United States