Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
1200

Summary

Conditions
  • Diabetes Mellitus - Type 2
  • Medication Adherence
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

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 li...

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: Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care. Determine if the effects of these UMS strategies vary by patients' literacy skills and language. Using mixed methods, evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the interventions. Assess the costs required to deliver either intervention from a health system perspective.

Tracking Information

NCT #
NCT03185741
Collaborators
  • Icahn School of Medicine at Mount Sinai
  • Emory University
  • Northwestern Memorial Hospital
Investigators
Principal Investigator: Michael Wolf, PhD MPH Northwestern University