Adherence
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence - Pill Count | 6 months after Baseline | 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. |
| Medication Adherence - Proper Use | 6 Months after Baseline | 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. |
| Medication Adherence - ASK12 | 6 Months after Baseline | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 6 months after Baseline | 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. |
| Hemoglobin A1c | 6 months after Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 677 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 2 Month | Lost to Follow-up | 24 | 26 |
| 2 Month | Stopped per NIH Hold | 51 | 13 |
| 2 Month | Withdrawal by Subject | 3 | 3 |
| 6 Month | Death | 0 | 1 |
| 6 Month | Lost to Follow-up | 20 | 27 |
| 6 Month | Stopped per NIH Hold | 81 | 81 |
| 6 Month | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Enhanced Usual Care | Total | Text or Portal |
|---|---|---|---|
| Age, Continuous | 60.8 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 Participants | 228 Participants | 160 Participants |
| Health Literacy, Newest Vital Sign (NVS) Limited | 109 Participants | 260 Participants | 151 Participants |
| Health Literacy, Newest Vital Sign (NVS) Marginal | 78 Participants | 188 Participants | 110 Participants |
| Health Literacy, Newest Vital Sign (NVS) Missing | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 14 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 60 Participants | 156 Participants | 96 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 26 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 174 Participants | 468 Participants | 294 Participants |
| Recruitment Site Erie | 229 Participants | 595 Participants | 366 Participants |
| Recruitment Site Northwestern | 27 Participants | 82 Participants | 55 Participants |
| Sex: Female, Male Female | 168 Participants | 425 Participants | 257 Participants |
| Sex: Female, Male Male | 88 Participants | 252 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 256 | 1 / 421 |
| other Total, other adverse events | 0 / 256 | 0 / 421 |
| serious Total, serious adverse events | 0 / 256 | 0 / 421 |
Outcome results
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Enhanced Usual Care | Medication Adherence - ASK12 | 22.40 score on a scale |
| Text or Portal | Medication Adherence - ASK12 | 22.06 score on a scale |
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Enhanced Usual Care | Medication Adherence - Pill Count | 0.46 Probability of adherence (PT/PP => 0.8) |
| Text or Portal | Medication Adherence - Pill Count | 0.53 Probability of adherence (PT/PP => 0.8) |
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Enhanced Usual Care | Medication Adherence - Proper Use | 0.71 Probability of Proper Use (Yes) |
| Text or Portal | Medication Adherence - Proper Use | 0.71 Probability of Proper Use (Yes) |
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Enhanced Usual Care | Hemoglobin A1c | 0.23 percentage of glycated hemoglobin |
| Text or Portal | Hemoglobin A1c | 0.003 percentage of glycated hemoglobin |
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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Enhanced Usual Care | Systolic Blood Pressure | -0.04 mmHg |
| Text or Portal | Systolic Blood Pressure | 1.79 mmHg |