A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens

NCT02820753 | Completed Results DMC

• 1 other identifier: 1R01AG046352-01A1
• Study Type: interventional
• Target: 677
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence

Keywords

Universal Medication Schedule; Health Literacy; Medication adherence

Outcome Measures

Primary Outcomes (3)

• Medication Adherence - Pill Count

  Pill Count is conducted for all pill form medications using an electronic pill counter at baseline and 6 months. The proportion of pills taken over pills prescribed (PT/PP) will be calculated for each medication at each time point. Pills taken will be calculated by subtracting the number of pills from the total quantity prescribed. Pills prescribed will be calculated by multiplying the number of pills prescribed each day by the number of days since the medication was filled. A proportion of pills taken over pills prescribed (PT/PP) of 80% or more is considered adherent. Analyses were performed using 2-level Generalized linear models (PROC GENMOD), with medications nested in participants and with a logit link. Confounding variables, such as adherence at baseline, gender, age, language, health status and medication regimen complexity index (MRCI) were included as fixed effects in the models. Results are presented as predicted probabilities with 95% Confidence Intervals.

  6 months after Baseline

• Medication Adherence - Proper Use

  Participants are asked questions about their 24 hour recall of medication use for each of their medications; they are asked to specify the amount taken (dose), the number of times the med was taken (frequency), the total number of pills taken, and when the doses were taken (to calculate spacing: hours between doses). Proper Use will be scored as yes or no, reflecting having demonstrated all of the following: correct dose, frequency, total and spacing based on the medication bottle instructions. Results are presented as predicted probabilities with 95% Confidence Intervals. Analyses were performed using 2-level Generalized linear models (PROC GENMOD), with medications nested in participants and with a logit link. Confounding variables, such as recruitment time, clinic, health status, gender, age, time effect, and medication regimen complexity index (MRCI) were included as fixed effects in the models.

  6 Months after Baseline

• Medication Adherence - ASK12

  Participants completed the ASK-12 questionnaire, a brief measure of adherence that cover three key domains: inconvenience/forgetfulness, treatment beliefs and behavior. The ASK-12 is scored by summing the selected responses (with scores ranging from 12 to 60) with higher scores indicating greater barriers to adherence. Analyses were performed using Generalized linear models (PROC GENMOD), with a repeated subject effect, and an identity link. Confounding variables such as health status, gender, age, health activation (CHAI), language, time effect and number of chronic conditions were included as fixed effects in the models. Results are presented as predicted probabilities with 95% Confidence Intervals.

  6 Months after Baseline

Other Outcomes (2)

• Systolic Blood Pressure

  6 months after Baseline

• Hemoglobin A1c

  6 months after Baseline

Study Arms (2)

Enhanced Usual Care

NO INTERVENTION

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

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.

Behavioral: EHR + (Text or Portal)

Interventions

EHR + (Text or Portal) BEHAVIORAL

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.

Text or Portal

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major cognitive, visual, or hearing impairment

Sponsors & Collaborators

• Northwestern University: lead
• University of North Carolina: collaborator
• Emory University: collaborator
• Vanderbilt University: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 28823927 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Due to an NIA administrative hold from July 2018-April 2019, recruitment has halted for that time period and 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. Additionally, due to restrictions to in-person interviews due to COVID-19, we were unable to recruit new patients starting March 12, 2020

Results Point of Contact

• Title: Stephanie Batio
• Organization: Northwestern University

stephanie.batio@northwestern.edu

312-503-4684

Study Officials

• Michael S Wolf, PHD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Stacy C Bailey, PHD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: July 1, 2016
• Study Start: April 3, 2017
• Primary Completion: September 21, 2020
• Study Completion: September 21, 2020
• Last Updated: February 1, 2022
• Results First Posted: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)