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A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens

A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02820753
Enrollment
677
Registered
2016-07-01
Start date
2017-04-03
Completion date
2020-09-21
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence

Keywords

Universal Medication Schedule, Health Literacy, Medication adherence

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.

Interventions

BEHAVIORALEHR + (Text or Portal)

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.

Sponsors

University of North Carolina
CollaboratorOTHER
Emory University
CollaboratorOTHER
Vanderbilt University
CollaboratorOTHER
Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Medication Adherence - Pill Count6 months after BaselinePill 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.
Medication Adherence - Proper Use6 Months after BaselineParticipants 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.
Medication Adherence - ASK126 Months after BaselineParticipants 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.

Other

MeasureTime frameDescription
Systolic Blood Pressure6 months after BaselineSystolic blood pressure will be collected on all participants at baseline and 6 months. Change of Systolic blood pressure from baseline will be measured, only in those who are diagnosed with hypertension. Negative Least Square Means indicate a decrease of systolic blood pressure, whereas a positive Least Square Means indicate an increase of systolic blood pressure by 6 Months. Analyses were performed using Generalized linear models (PROC GENMOD), with an identity link. Confounding variables, such as mean systolic blood pressure at baseline, gender, age, race, and number of prescribed medications were included as fixed effects in the models. Results are presented as adjusted least square means with 95% Confidence Intervals.
Hemoglobin A1c6 months after BaselineHemoglobin A1c (hbA1c) will be collected on diabetic patients only, at baseline and 6 months. Change of hbA1c from baseline is modelled. A positive Least Square Mean indicates an increase of hbA1c at 6 months, whereas a negative Least Square Mean indicates a decrease of hbA1c. Analyses were performed using Generalized linear models (PROC GENMOD), with an identity link. Confounding variables, such as hbA1c at baseline, gender, age, health status, language, medication regimen complexity index (MRCI), and health literacy (Newest Vital Sign) were included as fixed effects in the models. Results are presented as adjusted least square means with 95% Confidence Intervals.

Countries

United States

Participant flow

Participants by arm

ArmCount
Enhanced Usual Care
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).
256
Text or Portal
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. EHR + (Text or Portal): 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.
421
Total677

Withdrawals & dropouts

PeriodReasonFG000FG001
2 MonthLost to Follow-up2426
2 MonthStopped per NIH Hold5113
2 MonthWithdrawal by Subject33
6 MonthDeath01
6 MonthLost to Follow-up2027
6 MonthStopped per NIH Hold8181
6 MonthWithdrawal by Subject22

Baseline characteristics

CharacteristicEnhanced Usual CareTotalText or Portal
Age, Continuous60.8 years
STANDARD_DEVIATION 6.4
60.9 years
STANDARD_DEVIATION 6.8
61.0 years
STANDARD_DEVIATION 7
Health Literacy, Newest Vital Sign (NVS)
Adequate
68 Participants228 Participants160 Participants
Health Literacy, Newest Vital Sign (NVS)
Limited
109 Participants260 Participants151 Participants
Health Literacy, Newest Vital Sign (NVS)
Marginal
78 Participants188 Participants110 Participants
Health Literacy, Newest Vital Sign (NVS)
Missing
1 Participants1 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
6 Participants11 Participants5 Participants
Race (NIH/OMB)
Asian
6 Participants14 Participants8 Participants
Race (NIH/OMB)
Black or African American
60 Participants156 Participants96 Participants
Race (NIH/OMB)
More than one race
10 Participants26 Participants16 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants2 Participants
Race (NIH/OMB)
White
174 Participants468 Participants294 Participants
Recruitment Site
Erie
229 Participants595 Participants366 Participants
Recruitment Site
Northwestern
27 Participants82 Participants55 Participants
Sex: Female, Male
Female
168 Participants425 Participants257 Participants
Sex: Female, Male
Male
88 Participants252 Participants164 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2561 / 421
other
Total, other adverse events
0 / 2560 / 421
serious
Total, serious adverse events
0 / 2560 / 421

Outcome results

Primary

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.

Time frame: 6 Months after Baseline

ArmMeasureValue (LEAST_SQUARES_MEAN)
Enhanced Usual CareMedication Adherence - ASK1222.40 score on a scale
Text or PortalMedication Adherence - ASK1222.06 score on a scale
p-value: 0.4195% CI: [-1.16, 0.48]Mixed Models Analysis
Primary

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.

Time frame: 6 months after Baseline

Population: Observations were excluded if: 1.Medications were not in pill form; 2.Participants couldn't provide quantities on their bottles; 3.Missing Fill or Start Dates, 4.Participants started their medications on the same date as their pill count date; 5. Missing medications labels; 6. Participants combined medication bottles and discarded their old bottles; 7. Pills taken \> Quantity on bottle; 8. PRN Medications

ArmMeasureValue (LEAST_SQUARES_MEAN)
Enhanced Usual CareMedication Adherence - Pill Count0.46 Probability of adherence (PT/PP => 0.8)
Text or PortalMedication Adherence - Pill Count0.53 Probability of adherence (PT/PP => 0.8)
p-value: 0.0495% CI: [0.01, 0.51]Mixed Models Analysis
Primary

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.

Time frame: 6 Months after Baseline

Population: Observations were excluded if 1. the medication bottle had a missing label, or 2. participants did not complete the 24 hour med recall use questions

ArmMeasureValue (LEAST_SQUARES_MEAN)
Enhanced Usual CareMedication Adherence - Proper Use0.71 Probability of Proper Use (Yes)
Text or PortalMedication Adherence - Proper Use0.71 Probability of Proper Use (Yes)
p-value: 0.5395% CI: [-0.08, 0.15]Mixed Models Analysis
Other Pre-specified

Hemoglobin A1c

Hemoglobin A1c (hbA1c) will be collected on diabetic patients only, at baseline and 6 months. Change of hbA1c from baseline is modelled. A positive Least Square Mean indicates an increase of hbA1c at 6 months, whereas a negative Least Square Mean indicates a decrease of hbA1c. Analyses were performed using Generalized linear models (PROC GENMOD), with an identity link. Confounding variables, such as hbA1c at baseline, gender, age, health status, language, medication regimen complexity index (MRCI), and health literacy (Newest Vital Sign) were included as fixed effects in the models. Results are presented as adjusted least square means with 95% Confidence Intervals.

Time frame: 6 months after Baseline

ArmMeasureValue (LEAST_SQUARES_MEAN)
Enhanced Usual CareHemoglobin A1c0.23 percentage of glycated hemoglobin
Text or PortalHemoglobin A1c0.003 percentage of glycated hemoglobin
p-value: 0.3395% CI: [-0.68, 0.23]Mixed Models Analysis
Other Pre-specified

Systolic Blood Pressure

Systolic blood pressure will be collected on all participants at baseline and 6 months. Change of Systolic blood pressure from baseline will be measured, only in those who are diagnosed with hypertension. Negative Least Square Means indicate a decrease of systolic blood pressure, whereas a positive Least Square Means indicate an increase of systolic blood pressure by 6 Months. Analyses were performed using Generalized linear models (PROC GENMOD), with an identity link. Confounding variables, such as mean systolic blood pressure at baseline, gender, age, race, and number of prescribed medications were included as fixed effects in the models. Results are presented as adjusted least square means with 95% Confidence Intervals.

Time frame: 6 months after Baseline

Population: This measure was only used for participants who are diagnosed with hypertension, those who are not were not included.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Enhanced Usual CareSystolic Blood Pressure-0.04 mmHg
Text or PortalSystolic Blood Pressure1.79 mmHg
p-value: 0.2795% CI: [-1.39, 5.06]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026