A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens

Northwestern University

Status: Completed

Conditions: Adherence

Treatments: Behavioral: EHR + (Text or Portal)

Study type: Interventional

Funder types: Other

Identifiers

NCT02820753

1R01AG046352-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 677 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 50+
• English or Spanish speaking
• Prescribed 3+ medications
• Primarily responsible for administering own medication
• Owns a cell phone and feels comfortable receiving texts
• Access and proficient in using internet at home and has a personal email address

Exclusion criteria

• Major cognitive, visual, or hearing impairment
• Doesn't meet inclusion criteria.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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677 participants in 2 patient groups

Enhanced Usual Care

No Intervention group

Description:

Patients who have not received the initial 6 weeks of text message reminders telling them to take their medicines; or did not complete at least 1 portal survey that asks them if they filled their medications, if they had any side effects or concerns; or did not receive either intervention will be considered as enhanced usual care. Patients will only receive EHR tools (patient-friendly med-sheets about their medicines, MedList putting their medicines into the Universal Medication Schedule, and UMS sigs on their Rx bottles).

Text or Portal

Active Comparator group

Description:

Participants who received EHR strategies as well as, the initial 6 weeks of SMS messaging continuously that remind them to take their medicines; or logged on to the patient portal and completed at least one survey will be considered as receiving the intervention.

Treatment:

Behavioral: EHR + (Text or Portal)