NCT02820753

A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 677 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will leverage available technologies and test strategies to impart the Universal Medication Schedule (UMS) in primary care to help patients understand, consolidate, safely use, and adhere to their complex medication regimens.

Detailed description

The study investigators will conduct a patient-randomized controlled trial using a 2x2 factorial design to compare the effectiveness of interventions, alone or in combination, to one another. 1505 English and Spanish-speaking patients who are ≥ 50 years old, from a federally qualified health center (FQHC) in Chicago, and prescribed ≥ 3 Rx medications will be randomized to receive: 1) Enhanced Usual Care (EHR tools), 2) EHR tools + SMS, 3) EHR + Portal, or 4) EHR + SMS + Portal. The study aims to: 1. Compare the effectiveness of the UMS EHR tools, with or without SMS and/or Portal interventions. 2. Evaluate the 'fidelity' (reliability) of each strategy and explore patient, staff, physician, and health system factors influencing the delivery of the interventions, alone and in combination 3. Assess the costs required to deliver each of the interventions from a health system perspective Due to an NIA administrative hold, the interventions were not implemented as planned. Hence it was determined that the primary analysis would be "per-protocol" rather than intent-to-treat to assess the effect of the interventions under optimal conditions. Participants who either received the initial 6 weeks of SMS messaging continuously, or logged on to the patient portal and completed at least one survey will be considered as receiving the intervention. Those who have not received the initial 6 weeks of texting or completed at least 1 portal survey will be considered as enhanced usual care.

Conditions

• Adherence

Interventions

Type	Name	Description
BEHAVIORAL	EHR + (Text or Portal)	Per protocol analysis: Patients who received the initial 6 weeks of SMS messaging continuously, or logged on to the patient portal and completed at least one survey.

Timeline

• Start date: 2017-04-03
• Primary completion: 2020-09-21
• Completion: 2020-09-21
• First posted: 2016-07-01
• Last updated: 2022-02-01
• Results posted: 2022-02-01

Locations

1 site across 1 country: United States