Promoting the Universal Medication Schedule Via Mobile and EHR Technologies

NCT ID: NCT02248857

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-12-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care

Employ the current standard of care. No intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

UMS strategy

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.

Group Type: EXPERIMENTAL

UMS Strategy

Intervention Type: 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 + SMS texting reminders

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.

Group Type: EXPERIMENTAL

UMS Strategy

Intervention Type: 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.

SMS Texting Reminders

Intervention Type: 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.

Interventions

UMS Strategy

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.

Intervention Type: OTHER

SMS Texting Reminders

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Michael S. Wolf

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Wolf, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00097744

Identifier Type: -

Identifier Source: org_study_id