N/A
Completed N=767
Regimen Education and Messaging in Diabetes (REMinD)
Type 2 Diabetes Mellitus · Medication Adherence
Source: ClinicalTrials.gov NCT03185741 ↗
Enrolled (actual)
767
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Medication Adherence: Pill Count — 0.28; 0.29; 0.30 Probability of adherence (PT/PP =>0.80)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication Adherence: Pill Count |
0.28; 0.29; 0.30 | — |
| SECONDARY Medication Adherence: 24-hour Recall |
0.72; 0.67; 0.69 | — |
| SECONDARY Medication Adherence: ASK-12 |
23.0; 23.89; 23.22 | — |
| SECONDARY Treatment Knowledge |
0.73; 0.73; 0.75 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus diagnosis
- Most recent hba1c value ≥7.5%.
- Seek care at participating general internal medicine practices in Chicago or New York City.
- English or Spanish speaking
- Take 5 or more prescription drugs for chronic conditions (including 1 study medication)
Exclusion Criteria
- Severe uncorrectable vision or hearing impairment
- Cognitive impairment (≥2 errors on a 6-item dementia screening tool or a chart-documented diagnosis of dementia)
- Not primarily responsible for administering his/her medications
- Does not own a cell phone that can receive text messages
- Not comfortable receiving text messages
Data sourced from ClinicalTrials.gov (NCT03185741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.