High-risk MedicationsNCT02785458
Testing a Medication Risk Communication and Surveillance Strategy: The EMC2 Trial
A study testing EMC2 Strategy in people with High-risk Medications, run by Northwestern University at 1 site in United States.
Trial summary
This study evaluates the effectiveness of an electronic health record based educational intervention (the EMC2 strategy) to improve patient understanding and use of higher-risk medications. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- High-risk Medications
- What is being tested?
- EMC2 Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,005 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2017to 20 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 and older
- English or spanish speaking
- Primarily responsible for administering own medications
- New prescription of one of 66 study medications on day of recruitment
- Has a personal mobile or land line phone
Who cannot join
- Severe, uncorrectable vision
- Hearing or cognitive impairments
Trial locations and contacts
1 site in 1 country.
United States1 site
Near North Health Services Corporation
Chicago, Illinois, 60610
About this study
This study evaluates the effectiveness of an electronic health record based educational intervention (the EMC2 strategy) to improve patient understanding and use of higher-risk medications. Half of the participants will receive the intervention, while the other half will receive the usual amount of information (usual care).
Read the detailed description
Research has repeatedly demonstrated that individuals lack essential information on how to safely take prescribed (Rx) medications. A risk communication and surveillance strategy is needed in primary care to ensure that patients are adequately informed about medication risks and are taking prescribed regimens safely.
The investigators devised an Electronic health record-based Medication Complete Communication (EMC2) Strategy that leverages electronic health record (EHR) and interactive voice response (IVR) technologies to:
- prompt and guide provider counseling,
- automate the delivery of Medication Guides at prescribing,
- follow patients post-visit to confirm prescription understanding and use, and
- deliver a care alert back to providers to inform them of any potential harms.
- Conditions
- High-risk Medications
- Being tested
- EMC2 Strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMC2 StrategyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Subjects will receive the current standard of care. |
| EMC2 Strategy | Experimental | Subjects will receive the EMC2 Strategy. See description of strategy below. Receives: Behavioral: EMC2 Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Knowledge (0-100)
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
Measured: Baseline to 3 Months post baseline
Secondary outcomes (1)
Probability of Prescription Medication Proper Use
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
Measured: 1 Month post baseline to 3 Months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study start8 Jun 2017
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for High-risk MedicationsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Boston Medical Center, University of North Carolina, Chapel Hill, University of Illinois at Chicago
- Responsible party
- Principal investigator, Michael S. Wolf, Northwestern University
- Investigators
- Michael S Wolf, PhD, Principal investigator, Northwestern UniversityStacy C Bailey, PhD, Principal investigator, Northwestern UniversityMichael K Paasche-Orlow, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785458
- Sponsor's protocol ID
- STU00201638
- Other IDs
- 1R01DK103684
- Status last verified
- Jan 2021
- First submitted
- 12 Apr 2016
- Last updated
- 27 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Medication Risk Communication and Surveillance Strategy: The EMC2 Trial
- ClinicalTrials.gov ID
- NCT02785458
- Acronym / sponsor ID
- STU00201638
- Conditions
- High-risk Medications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Boston Medical Center, University of North Carolina, Chapel Hill, University of Illinois at Chicago
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Posted 23 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness of an electronic health record based educational intervention (the EMC2 strategy) to improve patient understanding and use of higher-risk medications. Half of the participants will receive the intervention, while the other half will receive the usual amount of information (usual care).
Detailed description
Research has repeatedly demonstrated that individuals lack essential information on how to safely take prescribed (Rx) medications. A risk communication and surveillance strategy is needed in primary care to ensure that patients are adequately informed about medication risks and are taking prescribed regimens safely.
The investigators devised an Electronic health record-based Medication Complete Communication (EMC2) Strategy that leverages electronic health record (EHR) and interactive voice response (IVR) technologies to:
- prompt and guide provider counseling,
- automate the delivery of Medication Guides at prescribing,
- follow patients post-visit to confirm prescription understanding and use, and
- deliver a care alert back to providers to inform them of any potential harms.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Subjects will receive the current standard of care. |
| EMC2 Strategy | Experimental | Behavioral: EMC2 StrategySubjects will receive the EMC2 Strategy. See description of strategy below. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21 and older
- English or spanish speaking
- Primarily responsible for administering own medications
- New prescription of one of 66 study medications on day of recruitment
- Has a personal mobile or land line phone
Key exclusion criteria (2 listed)
- Severe, uncorrectable vision
- Hearing or cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMC2 StrategyThe 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. | Behavioural | EMC2 Strategy |
Primary outcome
Medication Knowledge (0-100)
Time frame: Baseline to 3 Months post baseline
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
1 secondary outcome
Probability of Prescription Medication Proper Use
Time frame: 1 Month post baseline to 3 Months post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for High-risk Medications
Not yet recruitingObservational study
Optimization and Validation of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy
Acute Coronary Syndrome (ACS), High Bleeding Risk (HBR)
Recruiting
Evaluation of Medication Management Service
Medication Adherence, Medication Safety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Wolf, PhD principal investigator
Northwestern University
Stacy C Bailey, PhD principal investigator
Northwestern University
Michael K Paasche-Orlow, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMC2 Strategy in people with High-risk Medications, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Knowledge (0-100) (time frame: Baseline to 3 Months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021; AzTrials last refreshed its copy on 1 Nov 2026.