Promoting the Universal Medication Schedule Via Mobile and EHR Technologies

NCT02248857 | Completed Results

• 1 other identifier: STU00097744
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study test the effectiveness of the Universal Medication Schedule (UMS), which was designed as a strategy to standardize and simplify medication instructions to support safe and effective prescription drug use among diabetic.

Conditions

Type 2 Diabetes

Keywords

UMS; medication schedule; diabetes; drug labeling

Outcome Measures

Primary Outcomes (1)

• Prescription Understanding

  Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals.

  6 months after baseline

Secondary Outcomes (4)

• Medication Knowledge

  6 months after baseline

• Medication Adherence: Pill Count

  6 months after baseline

• Medication Adherence: PMAQ

  6 months after baseline

• Medication Adherence: Pharmacy Records

  6 months after baseline

Other Outcomes (3)

• Changes in Blood Pressure

  6 months before baseline to 1 year after baseline

• Changes in Hemoglobin A1c (hbA1c)

  6 months before baseline to 1 year after baseline

• Changes in Low-density Lipoprotein Cholesterol (LDL)

  6 months before baseline to 1 year after baseline

Study Arms (3)

Usual Care

NO INTERVENTION

Employ the current standard of care. No intervention.

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. 1. Prescription instructions will be adapted to UMS to establish four standard time intervals 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 content from a patient's perspective and following health literacy best practices. 3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.

Other: UMS Strategy

UMS strategy + SMS texting reminders

EXPERIMENTAL

In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.

Other: UMS Strategy; Other: SMS Texting Reminders

Interventions

UMS Strategy OTHER

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 texting reminders

SMS Texting Reminders OTHER

In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.

UMS strategy + SMS texting reminders

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of type II diabetes
• age 30 or older
• taking 3 or more prescription medications for chronic conditions
• English or Spanish speaking

You may not qualify if:

• self-reported severe, uncorrectable vision
• hearing impairment
• cognitive impairment
• not responsible for administering his/her own medications
• not able to receive text messages on their cell phone

Sponsors & Collaborators

• Northwestern University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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: September 22, 2014
• First Posted: September 25, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 25, 2019
• Results First Posted: March 25, 2019

Record last verified: 2018-12

Locations

US (1)