Regimen Education and Messaging in Diabetes (REMinD)

NCT03185741 | Completed Results DMC

• 1 other identifier: R01NR015444
• Study Type: interventional
• Target: 767
• Locations: 1 country
• Sites: 2

Brief 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. 1.Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care.
2. 2.Determine if the effects of these UMS strategies vary by patients' literacy skills and language.
3. 3.Using mixed methods, evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the interventions.
4. 4.Assess the costs required to deliver either intervention from a health system perspective.

Conditions

Diabetes Mellitus, Type 2; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Medication Adherence: Pill Count

  Adherence will be measured for each prescription medication using an objective pill count of the number of pills within each prescription bottle. The proportion of pills taken over pills prescribed (PT/PP) will be calculated for each medication at baseline and 6Month. Pills taken will be calculated by subtracting the number of pills from the total quantity prescribed. Pills prescribed will be calculated by multiplying the number of pills prescribed each day by the number of days since the medication was filled. A proportion of pills taken over pills prescribed (PT/PP) of 80% or more is considered adherent.

  6 months after baseline

Secondary Outcomes (3)

• Medication Adherence: 24-hour Recall

  6 months after baseline

• Medication Adherence: ASK-12

  6 months after baseline

• Treatment Knowledge

  6 months after baseline

Study Arms (3)

UMS Strategy

EXPERIMENTAL

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.

Behavioral: UMS Strategy

UMS Strategy + SMS Text Messaging

EXPERIMENTAL

In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.

Behavioral: UMS Strategy; Behavioral: SMS Text Messaging

Usual Care

NO INTERVENTION

Patients of providers randomized to the usual care arm will receive their standard care

Interventions

UMS Strategy BEHAVIORAL

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; UMS Strategy + SMS Text Messaging

SMS Text Messaging BEHAVIORAL

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

UMS Strategy + SMS Text Messaging

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• Emory University: collaborator
• Northwestern Memorial Hospital: collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Due to COVID-19, our recruitment was reduced, approved by the sponsor, from a total sample size of 750 vs. 900 to address new hardships in accessing patients and changes to healthcare delivery. In addition, all interviews were switched to remote vs. in-person data collection. This translated to a remote video interview (Zoom) to capture pill count vs. use of an automated pill counter, and blood pressure could not be collected following the revised protocol.

Results Point of Contact

• Title: Dr. Michael Wolf
• Organization: Northwestern University

mswolf@northwestern.edu

(312) 503-5592

Study Officials

• Michael Wolf, PhD MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 14, 2017
• Study Start: January 5, 2018
• Primary Completion: February 2, 2022
• Study Completion: November 30, 2022
• Last Updated: March 10, 2023
• Results First Posted: March 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)