Trial Outcomes & Findings for Development and Evaluation of an Electronic Health Record-based Medication Complete Communication (EMC2) Strategy (NCT NCT03652272)
NCT ID: NCT03652272
Last Updated: 2025-03-07
Results Overview
Patients are asked about their medication's 1) indication, 2) risks or warnings (knowledge of risk/warnings, correct or incorrect per item) and 3) side effects (knowledge of at least two side effects, correct or incorrect per item). Correct answers were graded blindly by 2 reviewers and any discordance was resolved by a third pharmacist. Total scores ranged from 0-100, with a higher value associated with a better outcome, that reflects the percent correct of possible points.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
301 participants
Primary outcome timeframe
Baseline
Results posted on
2025-03-07
Participant Flow
Participant milestones
| Measure |
EMC2
Following patient movement through a provider visit, the following activities will occur for a select list of pre-specified medications:
1. Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks
2. Patients will receive a Medication Guide + Summary with their After Visit Summary
3. Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study)
4. Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
EMC2: 1) Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks 2) Patients will receive a Medication Guide + Summary with their After Visit Summary 3) Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study) 4) Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
|
Usual Care
Usual care includes 1) variable provider counseling with limited or variable EHR notifications or counseling support; 2) no distribution of print medication information materials, including FDA Medication Guides in clinics and variable distribution in pharmacies; and 3) limited or no active surveillance of medication use post-visits.
|
|---|---|---|
|
Baseline
STARTED
|
143
|
158
|
|
Baseline
COMPLETED
|
143
|
158
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
3 Month
STARTED
|
143
|
158
|
|
3 Month
COMPLETED
|
126
|
143
|
|
3 Month
NOT COMPLETED
|
17
|
15
|
Reasons for withdrawal
| Measure |
EMC2
Following patient movement through a provider visit, the following activities will occur for a select list of pre-specified medications:
1. Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks
2. Patients will receive a Medication Guide + Summary with their After Visit Summary
3. Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study)
4. Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
EMC2: 1) Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks 2) Patients will receive a Medication Guide + Summary with their After Visit Summary 3) Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study) 4) Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
|
Usual Care
Usual care includes 1) variable provider counseling with limited or variable EHR notifications or counseling support; 2) no distribution of print medication information materials, including FDA Medication Guides in clinics and variable distribution in pharmacies; and 3) limited or no active surveillance of medication use post-visits.
|
|---|---|---|
|
3 Month
Withdrawal by Subject
|
1
|
1
|
|
3 Month
Lost to Follow-up
|
16
|
14
|
Baseline Characteristics
1 particiant with missing sex data
Baseline characteristics by cohort
| Measure |
EMC2
n=143 Participants
Following patient movement through a provider visit, the following activities will occur for a select list of pre-specified medications:
1. Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks
2. Patients will receive a Medication Guide + Summary with their After Visit Summary
3. Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study)
4. Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
EMC2: 1) Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks 2) Patients will receive a Medication Guide + Summary with their After Visit Summary 3) Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study) 4) Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
|
Usual Care
n=158 Participants
Usual care includes 1) variable provider counseling with limited or variable EHR notifications or counseling support; 2) no distribution of print medication information materials, including FDA Medication Guides in clinics and variable distribution in pharmacies; and 3) limited or no active surveillance of medication use post-visits.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.58 years
STANDARD_DEVIATION 13.99 • n=143 Participants
|
53.61 years
STANDARD_DEVIATION 14.88 • n=158 Participants
|
53.12 years
STANDARD_DEVIATION 14.44 • n=301 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=143 Participants • 1 particiant with missing sex data
|
95 Participants
n=157 Participants • 1 particiant with missing sex data
|
177 Participants
n=300 Participants • 1 particiant with missing sex data
|
|
Sex: Female, Male
Male
|
61 Participants
n=143 Participants • 1 particiant with missing sex data
|
62 Participants
n=157 Participants • 1 particiant with missing sex data
|
123 Participants
n=300 Participants • 1 particiant with missing sex data
|
|
Race/Ethnicity, Customized
Hispanic
|
20 Participants
n=141 Participants • 3 participants (2 EMC2 and 1 Usual Care) with missing race data
|
21 Participants
n=157 Participants • 3 participants (2 EMC2 and 1 Usual Care) with missing race data
|
41 Participants
n=298 Participants • 3 participants (2 EMC2 and 1 Usual Care) with missing race data
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
50 Participants
n=141 Participants • 3 participants (2 EMC2 and 1 Usual Care) with missing race data
|
82 Participants
n=157 Participants • 3 participants (2 EMC2 and 1 Usual Care) with missing race data
|
132 Participants
n=298 Participants • 3 participants (2 EMC2 and 1 Usual Care) with missing race data
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
60 Participants
n=141 Participants • 3 participants (2 EMC2 and 1 Usual Care) with missing race data
|
41 Participants
n=157 Participants • 3 participants (2 EMC2 and 1 Usual Care) with missing race data
|
101 Participants
n=298 Participants • 3 participants (2 EMC2 and 1 Usual Care) with missing race data
|
|
Race/Ethnicity, Customized
Non-Hispanic Others/Multiracial
|
11 Participants
n=141 Participants • 3 participants (2 EMC2 and 1 Usual Care) with missing race data
|
13 Participants
n=157 Participants • 3 participants (2 EMC2 and 1 Usual Care) with missing race data
|
24 Participants
n=298 Participants • 3 participants (2 EMC2 and 1 Usual Care) with missing race data
|
|
Education
Less than High School
|
10 Participants
n=142 Participants • 2 participants with missing education data
|
4 Participants
n=157 Participants • 2 participants with missing education data
|
14 Participants
n=299 Participants • 2 participants with missing education data
|
|
Education
High School Graduate
|
59 Participants
n=142 Participants • 2 participants with missing education data
|
59 Participants
n=157 Participants • 2 participants with missing education data
|
118 Participants
n=299 Participants • 2 participants with missing education data
|
|
Education
College Graduate
|
73 Participants
n=142 Participants • 2 participants with missing education data
|
94 Participants
n=157 Participants • 2 participants with missing education data
|
167 Participants
n=299 Participants • 2 participants with missing education data
|
PRIMARY outcome
Timeframe: BaselinePopulation: This trial was conducted at Northwestern Endocrinology and ACCESS Community Health Network. Due to the Covid-19 pandemic and its impact on recruitment (loss of providers, low patient volume, low prescription volume) at ACCESS performance sites, recruitment was halted in March 2021. The effectiveness of the intervention will be only tested on the Northwestern participants due to statistical power. 2 patients from the intervention group were excluded due to missing outcomes data at follow-up.
Patients are asked about their medication's 1) indication, 2) risks or warnings (knowledge of risk/warnings, correct or incorrect per item) and 3) side effects (knowledge of at least two side effects, correct or incorrect per item). Correct answers were graded blindly by 2 reviewers and any discordance was resolved by a third pharmacist. Total scores ranged from 0-100, with a higher value associated with a better outcome, that reflects the percent correct of possible points.
Outcome measures
| Measure |
EMC2
n=117 Participants
Following patient movement through a provider visit, the following activities will occur for a select list of pre-specified medications:
1. Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks
2. Patients will receive a Medication Guide + Summary with their After Visit Summary
3. Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study)
4. Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
EMC2: 1) Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks 2) Patients will receive a Medication Guide + Summary with their After Visit Summary 3) Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study) 4) Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
|
Usual Care
n=147 Participants
Usual care includes 1) variable provider counseling with limited or variable EHR notifications or counseling support; 2) no distribution of print medication information materials, including FDA Medication Guides in clinics and variable distribution in pharmacies; and 3) limited or no active surveillance of medication use post-visits.
|
|---|---|---|
|
Medication Specific Knowledge
|
63.82 score (0-100)
Interval 59.53 to 68.11
|
62.80 score (0-100)
Interval 58.8 to 66.8
|
SECONDARY outcome
Timeframe: Baseline-3 MonthsThe ASK-12 survey covers three adherence domains: inconvenience/forgetfulness, treatment beliefs and behavior. Scores range from 12-60, with higher scores translating to greater barriers to adherence.
Outcome measures
| Measure |
EMC2
n=117 Participants
Following patient movement through a provider visit, the following activities will occur for a select list of pre-specified medications:
1. Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks
2. Patients will receive a Medication Guide + Summary with their After Visit Summary
3. Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study)
4. Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
EMC2: 1) Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks 2) Patients will receive a Medication Guide + Summary with their After Visit Summary 3) Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study) 4) Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
|
Usual Care
n=147 Participants
Usual care includes 1) variable provider counseling with limited or variable EHR notifications or counseling support; 2) no distribution of print medication information materials, including FDA Medication Guides in clinics and variable distribution in pharmacies; and 3) limited or no active surveillance of medication use post-visits.
|
|---|---|---|
|
Medication Adherence- Ask 12
|
22.33 units on a scale
Interval 21.33 to 23.32
|
21.56 units on a scale
Interval 20.64 to 22.48
|
SECONDARY outcome
Timeframe: Baseline- 3 MonthsPopulation: The EMC2 Phase 2 Trial is conducted at Northwestern Endocrinology and ACCESS Community Health Network. Due to the Ccovid-19 pandemic and its impact on recruitment (loss of providers, low patient volume, low prescription volume) at ACCESS performance sites, recruitment was halted in March 2021. The Effectiveness of the intervention will be only tested on the Northwestern participants due to statistical power.
Patients will be asked the last day they took their medication and how. A patient's proper timing (last day and # of times per day), dosing (number of pills per dose), and spacing between doses (for BID, TID medications only) will be coded as correct or incorrect. Patients will be classified as having properly used their medication if they correctly reported all components.
Outcome measures
| Measure |
EMC2
n=111 Participants
Following patient movement through a provider visit, the following activities will occur for a select list of pre-specified medications:
1. Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks
2. Patients will receive a Medication Guide + Summary with their After Visit Summary
3. Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study)
4. Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
EMC2: 1) Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks 2) Patients will receive a Medication Guide + Summary with their After Visit Summary 3) Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study) 4) Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
|
Usual Care
n=146 Participants
Usual care includes 1) variable provider counseling with limited or variable EHR notifications or counseling support; 2) no distribution of print medication information materials, including FDA Medication Guides in clinics and variable distribution in pharmacies; and 3) limited or no active surveillance of medication use post-visits.
|
|---|---|---|
|
Medication Adherence - Proper Use
|
0.78 Probability of Proper Use (Yes)
Interval 0.62 to 0.88
|
0.62 Probability of Proper Use (Yes)
Interval 0.45 to 0.76
|
Adverse Events
EMC2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EMC2
n=143 participants at risk
Following patient movement through a provider visit, the following activities will occur for a select list of pre-specified medications:
1. Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks
2. Patients will receive a Medication Guide + Summary with their After Visit Summary
3. Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study)
4. Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
EMC2: 1) Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks 2) Patients will receive a Medication Guide + Summary with their After Visit Summary 3) Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study) 4) Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
|
Usual Care
n=158 participants at risk
Usual care includes 1) variable provider counseling with limited or variable EHR notifications or counseling support; 2) no distribution of print medication information materials, including FDA Medication Guides in clinics and variable distribution in pharmacies; and 3) limited or no active surveillance of medication use post-visits.
|
|---|---|---|
|
General disorders
Medication Side Effects
|
2.8%
4/143 • Adverse Event data was collected post 3.5 months from EMC2 intervention.
All participants were asked if they had experienced an adverse event to their prescribed medicine at the 3 month phone interview. If participants endorsed yes and provided details, an AE report was generated.
|
3.8%
6/158 • Adverse Event data was collected post 3.5 months from EMC2 intervention.
All participants were asked if they had experienced an adverse event to their prescribed medicine at the 3 month phone interview. If participants endorsed yes and provided details, an AE report was generated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place