Trial Outcomes & Findings for A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens (NCT NCT02820753)
NCT ID: NCT02820753
Last Updated: 2022-02-01
Results Overview
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.
COMPLETED
NA
677 participants
6 months after Baseline
2022-02-01
Participant Flow
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Baseline
STARTED
|
256
|
421
|
|
Baseline
COMPLETED
|
256
|
421
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
2 Month
STARTED
|
256
|
421
|
|
2 Month
COMPLETED
|
178
|
379
|
|
2 Month
NOT COMPLETED
|
78
|
42
|
|
6 Month
STARTED
|
253
|
418
|
|
6 Month
COMPLETED
|
150
|
307
|
|
6 Month
NOT COMPLETED
|
103
|
111
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
2 Month
Withdrawal by Subject
|
3
|
3
|
|
2 Month
Lost to Follow-up
|
24
|
26
|
|
2 Month
Stopped per NIH Hold
|
51
|
13
|
|
6 Month
Withdrawal by Subject
|
2
|
2
|
|
6 Month
Lost to Follow-up
|
20
|
27
|
|
6 Month
Stopped per NIH Hold
|
81
|
81
|
|
6 Month
Death
|
0
|
1
|
Baseline Characteristics
A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens
Baseline characteristics by cohort
| Measure |
Enhanced Usual Care
n=256 Participants
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
n=421 Participants
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.
|
Total
n=677 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
425 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
60 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
174 Participants
n=5 Participants
|
294 Participants
n=7 Participants
|
468 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Recruitment Site
Northwestern
|
27 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Recruitment Site
Erie
|
229 Participants
n=5 Participants
|
366 Participants
n=7 Participants
|
595 Participants
n=5 Participants
|
|
Health Literacy, Newest Vital Sign (NVS)
Limited
|
109 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
Health Literacy, Newest Vital Sign (NVS)
Marginal
|
78 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Health Literacy, Newest Vital Sign (NVS)
Adequate
|
68 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Health Literacy, Newest Vital Sign (NVS)
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after BaselinePopulation: 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
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.
Outcome measures
| Measure |
Enhanced Usual Care
n=559 Medications
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
n=1189 Medications
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.
|
|---|---|---|
|
Medication Adherence - Pill Count
|
0.46 Probability of adherence (PT/PP => 0.8)
Interval 0.41 to 0.52
|
0.53 Probability of adherence (PT/PP => 0.8)
Interval 0.48 to 0.57
|
PRIMARY outcome
Timeframe: 6 Months after BaselinePopulation: 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
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.
Outcome measures
| Measure |
Enhanced Usual Care
n=5854 Medications
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
n=11208 Medications
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.
|
|---|---|---|
|
Medication Adherence - Proper Use
|
0.71 Probability of Proper Use (Yes)
Interval 0.68 to 0.73
|
0.71 Probability of Proper Use (Yes)
Interval 0.69 to 0.73
|
PRIMARY outcome
Timeframe: 6 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.
Outcome measures
| Measure |
Enhanced Usual Care
n=255 Participants
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
n=421 Participants
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.
|
|---|---|---|
|
Medication Adherence - ASK12
|
22.40 score on a scale
Interval 21.75 to 23.05
|
22.06 score on a scale
Interval 21.48 to 22.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after BaselinePopulation: This measure was only used for participants who are diagnosed with hypertension, those who are not were not included.
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.
Outcome measures
| Measure |
Enhanced Usual Care
n=147 Participants
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
n=260 Participants
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.
|
|---|---|---|
|
Systolic Blood Pressure
|
-0.04 mmHg
Interval -3.73 to 3.64
|
1.79 mmHg
Interval -1.6 to 5.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 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.
Outcome measures
| Measure |
Enhanced Usual Care
n=56 Participants
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
n=115 Participants
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.
|
|---|---|---|
|
Hemoglobin A1c
|
0.23 percentage of glycated hemoglobin
Interval -0.18 to 0.64
|
0.003 percentage of glycated hemoglobin
Interval -0.28 to 0.29
|
Adverse Events
Enhanced Usual Care
Text or Portal
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place