Trial Outcomes & Findings for Testing a Medication Risk Communication and Surveillance Strategy: The EMC2 Trial (NCT NCT02785458)
NCT ID: NCT02785458
Last Updated: 2021-01-27
Results Overview
Adjusted Least-square means of Medication Knowledge are calculated based on patient's ability to identify each medication's purpose and side effects, risks, warnings and benefits using general linear mixed models, specifying the identity link (PROC GLIMMIX). Treatment assignment by time is the independent variable of interest and modeled as a fixed effect, and clinic as a random effect, with additional subject statement to model correlations with patient. Confounding variables, such as age, preferred language, race, education, health status, number of chronic diseases, drug class, and health literacy (Newest Vital Sign) are included as fixed effects in the model. Patients are asked 10 questions (a scale developed by our team), and each questions is scored as correct/incorrect, and percentage of correctly answered questions is calculated (0-100 with 100 as best). Results are presented as adjusted least square means with 95% Confidence Intervals
COMPLETED
NA
1005 participants
Baseline to 3 Months post baseline
2021-01-27
Participant Flow
Participant milestones
| Measure |
Usual Care
Subjects will receive the current standard of care.
|
EMC2 Strategy
Subjects will receive the EMC2 Strategy. See description of strategy below.
EMC2 Strategy: The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up.
|
|---|---|---|
|
Baseline
STARTED
|
526
|
479
|
|
Baseline
COMPLETED
|
526
|
479
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
1 Month
STARTED
|
526
|
479
|
|
1 Month
COMPLETED
|
443
|
404
|
|
1 Month
NOT COMPLETED
|
83
|
75
|
|
3 Months
STARTED
|
443
|
404
|
|
3 Months
COMPLETED
|
315
|
293
|
|
3 Months
NOT COMPLETED
|
128
|
111
|
Reasons for withdrawal
| Measure |
Usual Care
Subjects will receive the current standard of care.
|
EMC2 Strategy
Subjects will receive the EMC2 Strategy. See description of strategy below.
EMC2 Strategy: The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up.
|
|---|---|---|
|
1 Month
Withdrawal by Subject
|
2
|
1
|
|
1 Month
Lost to Follow-up
|
38
|
31
|
|
1 Month
Deemed Ineligible
|
1
|
0
|
|
1 Month
Completed Evaluation by Baseline
|
42
|
39
|
|
1 Month
Partial Interview
|
0
|
4
|
|
3 Months
Withdrawal by Subject
|
3
|
1
|
|
3 Months
Lost to Follow-up
|
25
|
21
|
|
3 Months
Completed Evaluation at 1 Month
|
100
|
89
|
Baseline Characteristics
23 Individuals refused to identify their race, 4 individuals did not know how to identify their race
Baseline characteristics by cohort
| Measure |
Usual Care
n=526 Participants
Subjects will receive the current standard of care.
|
EMC2 Strategy
n=479 Participants
Subjects will receive the EMC2 Strategy. See description of strategy below.
EMC2 Strategy: The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up.
|
Total
n=1005 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.34 years
STANDARD_DEVIATION 12.2 • n=526 Participants
|
49.5 years
STANDARD_DEVIATION 12.6 • n=479 Participants
|
50.0 years
STANDARD_DEVIATION 12.4 • n=1005 Participants
|
|
Sex: Female, Male
Female
|
319 Participants
n=526 Participants
|
299 Participants
n=479 Participants
|
618 Participants
n=1005 Participants
|
|
Sex: Female, Male
Male
|
207 Participants
n=526 Participants
|
180 Participants
n=479 Participants
|
387 Participants
n=1005 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
304 Participants
n=515 Participants • 23 Individuals refused to identify their race, 4 individuals did not know how to identify their race
|
372 Participants
n=463 Participants • 23 Individuals refused to identify their race, 4 individuals did not know how to identify their race
|
676 Participants
n=978 Participants • 23 Individuals refused to identify their race, 4 individuals did not know how to identify their race
|
|
Race/Ethnicity, Customized
Race · White
|
78 Participants
n=515 Participants • 23 Individuals refused to identify their race, 4 individuals did not know how to identify their race
|
35 Participants
n=463 Participants • 23 Individuals refused to identify their race, 4 individuals did not know how to identify their race
|
113 Participants
n=978 Participants • 23 Individuals refused to identify their race, 4 individuals did not know how to identify their race
|
|
Race/Ethnicity, Customized
Race · Hispanic or Latino
|
96 Participants
n=515 Participants • 23 Individuals refused to identify their race, 4 individuals did not know how to identify their race
|
32 Participants
n=463 Participants • 23 Individuals refused to identify their race, 4 individuals did not know how to identify their race
|
128 Participants
n=978 Participants • 23 Individuals refused to identify their race, 4 individuals did not know how to identify their race
|
|
Race/Ethnicity, Customized
Race · Others
|
37 Participants
n=515 Participants • 23 Individuals refused to identify their race, 4 individuals did not know how to identify their race
|
24 Participants
n=463 Participants • 23 Individuals refused to identify their race, 4 individuals did not know how to identify their race
|
61 Participants
n=978 Participants • 23 Individuals refused to identify their race, 4 individuals did not know how to identify their race
|
|
Education
Less than High School
|
116 Participants
n=523 Participants • 5 participants refused to answer the question, 1 did not know their highest education level
|
75 Participants
n=476 Participants • 5 participants refused to answer the question, 1 did not know their highest education level
|
191 Participants
n=999 Participants • 5 participants refused to answer the question, 1 did not know their highest education level
|
|
Education
High School Graduate
|
292 Participants
n=523 Participants • 5 participants refused to answer the question, 1 did not know their highest education level
|
318 Participants
n=476 Participants • 5 participants refused to answer the question, 1 did not know their highest education level
|
610 Participants
n=999 Participants • 5 participants refused to answer the question, 1 did not know their highest education level
|
|
Education
College Graduate
|
115 Participants
n=523 Participants • 5 participants refused to answer the question, 1 did not know their highest education level
|
83 Participants
n=476 Participants • 5 participants refused to answer the question, 1 did not know their highest education level
|
198 Participants
n=999 Participants • 5 participants refused to answer the question, 1 did not know their highest education level
|
|
Self-reported Health Status
Excellent/Very Good
|
128 Participants
n=524 Participants • 4 individuals refused to answer the question
|
113 Participants
n=477 Participants • 4 individuals refused to answer the question
|
241 Participants
n=1001 Participants • 4 individuals refused to answer the question
|
|
Self-reported Health Status
Good
|
179 Participants
n=524 Participants • 4 individuals refused to answer the question
|
177 Participants
n=477 Participants • 4 individuals refused to answer the question
|
356 Participants
n=1001 Participants • 4 individuals refused to answer the question
|
|
Self-reported Health Status
Fair/Poor
|
217 Participants
n=524 Participants • 4 individuals refused to answer the question
|
187 Participants
n=477 Participants • 4 individuals refused to answer the question
|
404 Participants
n=1001 Participants • 4 individuals refused to answer the question
|
|
Drug Class
Anticonvulsants
|
123 Participants
n=526 Participants
|
95 Participants
n=479 Participants
|
218 Participants
n=1005 Participants
|
|
Drug Class
Antidepressants
|
145 Participants
n=526 Participants
|
116 Participants
n=479 Participants
|
261 Participants
n=1005 Participants
|
|
Drug Class
Diabetes
|
24 Participants
n=526 Participants
|
32 Participants
n=479 Participants
|
56 Participants
n=1005 Participants
|
|
Drug Class
LABA
|
38 Participants
n=526 Participants
|
44 Participants
n=479 Participants
|
82 Participants
n=1005 Participants
|
|
Drug Class
NSAID
|
59 Participants
n=526 Participants
|
61 Participants
n=479 Participants
|
120 Participants
n=1005 Participants
|
|
Drug Class
PPI
|
25 Participants
n=526 Participants
|
27 Participants
n=479 Participants
|
52 Participants
n=1005 Participants
|
|
Drug Class
Others
|
112 Participants
n=526 Participants
|
104 Participants
n=479 Participants
|
216 Participants
n=1005 Participants
|
|
Preferred Language
English
|
479 Participants
n=526 Participants
|
457 Participants
n=479 Participants
|
936 Participants
n=1005 Participants
|
|
Preferred Language
Spanish
|
47 Participants
n=526 Participants
|
22 Participants
n=479 Participants
|
69 Participants
n=1005 Participants
|
|
Health Literacy (NVS)
Low
|
172 Participants
n=418 Participants • 174 individuals did not complete the health literacy assessment
|
177 Participants
n=388 Participants • 174 individuals did not complete the health literacy assessment
|
349 Participants
n=806 Participants • 174 individuals did not complete the health literacy assessment
|
|
Health Literacy (NVS)
Marginal
|
108 Participants
n=418 Participants • 174 individuals did not complete the health literacy assessment
|
111 Participants
n=388 Participants • 174 individuals did not complete the health literacy assessment
|
219 Participants
n=806 Participants • 174 individuals did not complete the health literacy assessment
|
|
Health Literacy (NVS)
Adequate
|
138 Participants
n=418 Participants • 174 individuals did not complete the health literacy assessment
|
100 Participants
n=388 Participants • 174 individuals did not complete the health literacy assessment
|
238 Participants
n=806 Participants • 174 individuals did not complete the health literacy assessment
|
PRIMARY outcome
Timeframe: Baseline to 3 Months post baselinePopulation: 127 individuals were excluded from analysis, because their study med was either a short term medication or an antibiotics
Adjusted Least-square means of Medication Knowledge are calculated based on patient's ability to identify each medication's purpose and side effects, risks, warnings and benefits using general linear mixed models, specifying the identity link (PROC GLIMMIX). Treatment assignment by time is the independent variable of interest and modeled as a fixed effect, and clinic as a random effect, with additional subject statement to model correlations with patient. Confounding variables, such as age, preferred language, race, education, health status, number of chronic diseases, drug class, and health literacy (Newest Vital Sign) are included as fixed effects in the model. Patients are asked 10 questions (a scale developed by our team), and each questions is scored as correct/incorrect, and percentage of correctly answered questions is calculated (0-100 with 100 as best). Results are presented as adjusted least square means with 95% Confidence Intervals
Outcome measures
| Measure |
Usual Care
n=459 Participants
Subjects will receive the current standard of care.
|
EMC2 Strategy
n=419 Participants
Subjects will receive the EMC2 Strategy. See description of strategy below.
EMC2 Strategy: The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up.
|
|---|---|---|
|
Medication Knowledge (0-100)
Baseline
|
71.2 score on a scale
Interval 68.5 to 73.9
|
71.9 score on a scale
Interval 68.9 to 74.8
|
|
Medication Knowledge (0-100)
1 Month
|
73.2 score on a scale
Interval 70.5 to 75.9
|
74.9 score on a scale
Interval 72.0 to 77.8
|
|
Medication Knowledge (0-100)
3 Months
|
73.2 score on a scale
Interval 70.4 to 75.9
|
75.0 score on a scale
Interval 72.0 to 78.0
|
SECONDARY outcome
Timeframe: 1 Month post baseline to 3 Months post baselinePopulation: 248 participants were excluded, due to either completing their evaluation early, or not filling their medication
Subjects will be asked to demonstrate proper use of the medication by indicating the correct dose (amount of medication taken each time), frequency (times per day), and total pills/units per day. For non-PRN medications, all must be answered correctly to be considered proper use (yes/no) , whereas for PRN medications, proper use is determined if the patient indicated the correct dose or less, the correct frequency or less, and the correct total pills/units or less. Proper use is modelled as a binary outcome, and General linear mixed models are used, specifying the logit link (PROC GLIMMIX). Treatment assignment by time is the independent variable of interest and modeled as a fixed effect, and clinic as a random effect, with additional subject statement to model correlations with patient. Confounding factors, such as drug class and health literacy (Newest Vital Sign) are also included in the model as fixed effects. Results are presented as adjusted least square means with 95% CI
Outcome measures
| Measure |
Usual Care
n=391 Participants
Subjects will receive the current standard of care.
|
EMC2 Strategy
n=366 Participants
Subjects will receive the EMC2 Strategy. See description of strategy below.
EMC2 Strategy: The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up.
|
|---|---|---|
|
Probability of Prescription Medication Proper Use
1 Month
|
0.84 Probability
Interval 0.75 to 0.9
|
0.81 Probability
Interval 0.71 to 0.88
|
|
Probability of Prescription Medication Proper Use
3 Month
|
0.83 Probability
Interval 0.73 to 0.9
|
0.80 Probability
Interval 0.68 to 0.88
|
Adverse Events
Usual Care
EMC2 Strategy
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