An interventional study of EHR + (Text or Portal) in Adherence, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-02-01.
Sponsored by Northwestern University · Not applicable, Interventional, and Health services research
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.
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:
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.
Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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Exclusion Criteria:
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).
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)
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
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
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
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
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
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
| Milestone | Enhanced Usual Care | Text or Portal |
|---|---|---|
| Started | 256 | 421 |
| Completed | 256 | 421 |
| Not completed | 0 | 0 |
| Milestone | Enhanced Usual Care | Text or Portal |
|---|---|---|
| Started | 256 | 421 |
| Completed | 178 | 379 |
| Not completed | 78 | 42 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Lost to follow-up | 24 | 26 |
| Withdrew: Stopped per nih hold | 51 | 13 |
| Milestone | Enhanced Usual Care | Text or Portal |
|---|---|---|
| Started | 253 | 418 |
| Completed | 150 | 307 |
| Not completed | 103 | 111 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Lost to follow-up | 20 | 27 |
| Withdrew: Stopped per nih hold | 81 | 81 |
| Withdrew: Death | 0 | 1 |
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.
| Probability of adherence (PT/PP => 0.8) | Enhanced Usual Care | Text or Portal |
|---|---|---|
| Medication Adherence - Pill Count | 0.46 (0.41 to 0.52) | 0.53 (0.48 to 0.57) |
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.
| Probability of Proper Use (Yes) | Enhanced Usual Care | Text or Portal |
|---|---|---|
| Medication Adherence - Proper Use | 0.71 (0.68 to 0.73) | 0.71 (0.69 to 0.73) |
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.
| score on a scale | Enhanced Usual Care | Text or Portal |
|---|---|---|
| Medication Adherence - ASK12 | 22.40 (21.75 to 23.05) | 22.06 (21.48 to 22.65) |
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.
| mmHg | Enhanced Usual Care | Text or Portal |
|---|---|---|
| Systolic Blood Pressure | -0.04 (-3.73 to 3.64) | 1.79 (-1.60 to 5.18) |
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.
| percentage of glycated hemoglobin | Enhanced Usual Care | Text or Portal |
|---|---|---|
| Hemoglobin A1c | 0.23 (-0.18 to 0.64) | 0.003 (-0.28 to 0.29) |
Collected over 6 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enhanced Usual Care | 0/256 (0%) | 0/256 (0%) | 0/256 (0%) |
| Text or Portal | 1/421 (0.2%) | 0/421 (0%) | 0/421 (0%) |
| Age, Continuous(years) | Enhanced Usual Care | Text or Portal | Total |
|---|---|---|---|
| Mean | 60.8 ± 6.4 | 61.0 ± 7.0 | 60.9 ± 6.8 |
| Sex: Female, Male(Participants) | Enhanced Usual Care | Text or Portal | Total |
|---|---|---|---|
| Female | 168 | 257 | 425 |
| Male | 88 | 164 | 252 |
| Race (NIH/OMB)(Participants) | Enhanced Usual Care | Text or Portal | Total |
|---|---|---|---|
| American Indian or Alaska Native | 6 | 5 | 11 |
| Asian | 6 | 8 | 14 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 60 | 96 | 156 |
| White | 174 | 294 | 468 |
| More than one race | 10 | 16 | 26 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Recruitment Site(Participants) | Enhanced Usual Care | Text or Portal | Total |
|---|---|---|---|
| Northwestern | 27 | 55 | 82 |
| Erie | 229 | 366 | 595 |
| Health Literacy, Newest Vital Sign (NVS)(Participants) | Enhanced Usual Care | Text or Portal | Total |
|---|---|---|---|
| Limited | 109 | 151 | 260 |
| Marginal | 78 | 110 | 188 |
| Adequate | 68 | 160 | 228 |
| Missing | 1 | 0 | 1 |
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