Clinical trial NCT02248857: Promoting the Universal Medication Schedule Via Mobile and EHR Technologies
Official title: Promoting the Universal Medication Schedule Via Mobile and EHR Technologies: A Physician-randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: UMS
medication schedule
diabetes
drug labeling
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-09-25
Enrollment: 452
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Research has shown the UMS (1) improves patients' understanding of how much to take of a medicine and when, and (2) reduces the number of times per day patients would take a multi-drug regimen. In this study, UMS tools will be exported into a second electronic health record platform to demonstrate ease of dissemination. Also, as patients may require assistance outside of clinic visits to adapt their prescription regimen to the UMS, this study will test the potential benefit of daily short message service (SMS) text reminders via cell phone.

We will conduct a three-arm, provider-randomized controlled trial among English and Spanish-speaking adults taking three or more prescription drugs to evaluate the effectiveness of the UMS strategy, with and without SMS text reminders, to improve patient understanding, consolidation, and adherence compared to usual care.We will conduct a three-arm, provider-randomized trial at two community health centers in Chicago, IL to evaluate the UMS and UMS+SMS text reminder strategies compared to usual care. English and Spanish-speaking patients who are prescribed three or more medications will be recruited and assessed by phone at baseline, three months, and six months.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prescription Understanding
timeFrame: 6 months after baseline
Secondary outcomes:
measure: Medication Knowledge
timeFrame: 6 months after baseline
measure: Medication Adherence: Pill Count
timeFrame: 6 months after baseline
measure: Medication Adherence: PMAQ
timeFrame: 6 months after baseline
measure: Medication Adherence: Pharmacy Records
timeFrame: 6 months after baseline
Other outcomes:
measure: Changes in Blood Pressure
timeFrame: 6 months before baseline to 1 year after baseline
measure: Changes in Hemoglobin A1c (hbA1c)
timeFrame: 6 months before baseline to 1 year after baseline
measure: Changes in Low-density Lipoprotein Cholesterol (LDL)
timeFrame: 6 months before baseline to 1 year after baseline
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Michael Wolf, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: