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
|Condition or disease||Intervention/treatment||Phase|
|Adherence||Behavioral: EHR + Text Behavioral: EHR + Portal Behavioral: EHR + Text + Portal||Not Applicable|
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:
- Compare the effectiveness of the UMS EHR tools, with or without SMS and/or Portal interventions.
- 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
- Assess the costs required to deliver each of the interventions from a health system perspective
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1505 participants|
|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|
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.
- 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.
- Systolic/diastolic blood pressure [ Time Frame: 6 months ]Systolic/diastolic blood pressure will be collected on all patients at baseline and 6 months.
- Hemoglobin A1c [ Time Frame: 6 months ]Hemoglobin A1c (hbA1c) will be collected on diabetic patients only, at baseline and 6 months.
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
|Contact: Guisselle A Wismer, MPHemail@example.com|
|Contact: Laura Curtis, MSfirstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Guisselle Wismer, MPH 312-503-3272 email@example.com|
|Principal Investigator:||Michael S Wolf, PHD||Northwestern University|
|Principal Investigator:||Stacy C Bailey, PHD||Northwestern University|