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A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02820753
Recruitment Status : Recruiting
First Posted : July 1, 2016
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
University of North Carolina
Emory University
Vanderbilt University
Information provided by (Responsible Party):
Michael S. Wolf, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Adherence Behavioral: EHR + Text Behavioral: EHR + Portal Behavioral: EHR + Text + Portal Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1505 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
No Intervention: Enhanced Usual Care
Patients will receive EHR tools (patient-friendly MedSheets about their medicines, MedList putting their medicines into the Universal Medication Schedule, and UMS sigs on their Rx bottles).
Active Comparator: EHR + Text
Patients receive EHR tools, as well as text reminders telling them to take their medicine. Texts will be set to patients' personal schedules and will have a standard length of time before patients then can opt back in to continue.
Behavioral: EHR + Text
Text reminders to promote adherence

Active Comparator: EHR + Portal
Patients receive EHR tools, as well as enrollment into their clinic's portal. Patients will be prompted every other week to fill out an online survey, asking if they filled their medication, about any side effects, or concerns. Any concerns or questions will be followed up by a nurse, providing a feedback loop for patients.
Behavioral: EHR + Portal
Engage portal to promote adherence and medication knowledge.

Active Comparator: EHR + Text + Portal
Patients in this arm will receive all interventions - EHR tools, text reminders, and portal communication.
Behavioral: EHR + Text + Portal
See if texting and portal use promote adherence more than each element alone.




Primary Outcome Measures :
  1. Medication adherence [ Time Frame: 6 months ]
    Adherence will be measured for each Rx medication using: 1) Self-report of how many pills and how often each medicine was taken over the last 24 hours, 2) objective pill count at baseline and 6 month interviews, 3) the proportion of days covered (PDC), a measurement of days covered with medication, based on pharmacy claims General adherence behaviors and barriers to treatment adherence will be assessed by the ASK-12 Adherence Barrier Survey.


Other Outcome Measures:
  1. Systolic/diastolic blood pressure [ Time Frame: 6 months ]
    Systolic/diastolic blood pressure will be collected on all patients at baseline and 6 months.

  2. Hemoglobin A1c [ Time Frame: 6 months ]
    Hemoglobin A1c (hbA1c) will be collected on diabetic patients only, at baseline and 6 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820753


Contacts
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Contact: Guisselle A Wismer, MPH 3125033272 delsalto@northwestern.edu
Contact: Laura Curtis, MS 3125035538 l-curtis@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Guisselle Wismer, MPH    312-503-3272    delsalto@northwestern.edu   
Sponsors and Collaborators
Northwestern University
University of North Carolina
Emory University
Vanderbilt University
Investigators
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Principal Investigator: Michael S Wolf, PHD Northwestern University
Principal Investigator: Stacy C Bailey, PHD Northwestern University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael S. Wolf, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02820753    
Other Study ID Numbers: 1R01AG046352-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael S. Wolf, Northwestern University:
Universal Medication Schedule
Health Literacy
Medication adherence