CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 767 enrolled
Drug / intervention
UMS Strategy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03185741
NCT03185741N/ACompleted

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

Northwestern University·interventional·Posted Jun 14, 2017·Updated Mar 10, 2023

In Brief

A clinical study evaluating UMS Strategy and SMS Text Messaging for Diabetes Mellitus, Type 2 and Medication Adherence. Completed, enrolled 767 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 14, 2017
Enrollment StartJan 5, 2018
Primary CompletionFeb 2, 2022
Study CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 9.0 years ago

Interventions

UMS Strategybehavioral

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 Messagingbehavioral

Patients will receive daily text message reminders about when to take medicines based on UMS intervals.