Clinical trial NCT02820753: A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens
Official title: A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence
Keywords: Universal Medication Schedule
Health Literacy
Medication adherence
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: Emory University
name: Vanderbilt University
First posted: 2016-07-01
Enrollment: 677
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Medication Adherence - Pill Count
timeFrame: 6 months after Baseline
measure: Medication Adherence - Proper Use
timeFrame: 6 Months after Baseline
measure: Medication Adherence - ASK12
timeFrame: 6 Months after Baseline
Secondary outcomes:
Other outcomes:
measure: Systolic Blood Pressure
timeFrame: 6 months after Baseline
measure: Hemoglobin A1c
timeFrame: 6 months after Baseline
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Michael S Wolf, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Stacy C Bailey, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bailey SC, Wismer GA, Parker RM, Walton SM, Wood AJJ, Wallia A, Brokenshire SA, Infanzon AC, Curtis LM, Kwasny MJ, Wolf MS. Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults. Contemp Clin Trials. 2017 Nov;62:21-26. doi: 10.1016/j.cct.2017.08.013. Epub 2017 Aug 18.