Opioid Use, UnspecifiedEMC2NCT02431793
EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use
A study testing EMC2 Strategy and SMS Text Reminders in people with Opioid Use, Unspecified, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of an electronic health record based strategy in promoting safe use of opioid medications after an Emergency Department (ED) visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Unspecified
- What is being tested?
- EMC2 Strategy and SMS Text Reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 652 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to enroll and remain in the study, patient subjects must meet all of the following criteria:
- Patient age 18 years and older
- English language speaking
- prescribed pill form of hydrocodone-acetaminophen opioid pain reliever
- own a cell phone with text messaging capabilities
- the patient is the person primarily responsible for administering medication
Who cannot join
- Subjects will be excluded from the study if any of the following conditions are met:
- Aged <18
- non-English speaking
- clinically unstable, psychologically impaired or intoxicated as judged by research staff member or emergency physician
- chronic opioid use, defined as daily or near daily use of opioid pain relievers for the past 90 days
- admitted to hospital
- unable to complete follow up phone interviews
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test the effectiveness of an electronic health record based strategy in promoting safe use of opioid medications after an Emergency Department (ED) visit. The electronic health record (EHR)-based strategy was designed to enhance provider counseling about opioids and to standardize and simplify the information that patients receive.
Read the detailed description
Research has shown that patients frequently leave the emergency department without sufficient knowledge about how to safely use their newly prescribed opioid pain relievers. Additionally, educational interventions have the ability to increase patient knowledge about medications. In this study, education interventions will be implemented at the level of the EHR and prompt increased provider counseling with a goal of improving patient knowledge and safe use of opioids after ED discharge.
The investigators will conduct a three-arm provider randomized controlled trial among English-speaking adults prescribed hydrocodone-acetaminophen to evaluate the effectiveness of the EMC2 strategy, with and without Short Message Service (SMS) text reminders, to improve patient understanding and safe use of their medication compared to usual care. This study will be conducted at an urban, academic emergency department (annual volume >85,000 patient visits) in Chicago, Illinois. English speaking patients will be recruited and assessed in person at baseline, and by phone at 2-4 days, 7-14 days, and 1 month after recruitment.
- Conditions
- Opioid Use, Unspecified
- Being tested
- EMC2 Strategy, SMS Text Reminders
- Keywords
- Opioids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMC2 StrategyBehavioural
Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language. Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.
SMS Text RemindersBehavioural
In addition to the components of the EMC2 strategy arm, patients will received daily text message reminders about the safe use of opioids for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Employ the standard of care, no intervention |
| EMC2 strategy | Experimental | Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.
1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices.
2. Prescribing instructions will be adapted to the Universal Medication Scheduled Take-Wait-Stop regimen for both the prescribing and dispensing of the medicine. This format uses simplified text and numeric characters to detail dose.
3. Provider counseling prompts: The providers for patients in this arm will be prompted to encourage counseling both in the ED and at follow-up time points. These prompts include: 1) An automated prompt to the ED physician upon signing the order; 2) an automated message to the PCP (if an in-system PCP) notifying them of the ED visit, new prescription, and counseling request; and 3) a request for the pharmacist to counsel patient printed automatically on the prescription. Receives: Behavioral: EMC2 Strategy |
| EMC2 strategy + SMS Text Reminders | Experimental | In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days. Receives: Behavioral: EMC2 Strategy; Behavioral: SMS Text Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe Medication Dosing (Prescription Understanding)
Patient's ability to demonstrate correctly dosing their prescription opioid-acetaminophen pain reliever will be assessed through a series of questions. Correct dosing will be scored for each medication as yes/no reflecting having demonstrated all of the following: proper dose (# of pills), appropriate spacing (hours between doses), and total daily dose (not exceeding recommended daily dose).
Measured: 7-14 days after enrollment
Secondary outcomes (4)
Medication Knowledge
The identification of the medications purpose, side effects, risks, warnings and benefits will be assessed through a structured questionnaire. Patients will be asked about each of the above via structured, open-ended items. Additionally, select questions from the validated Patient Opioid Education Measure and patient satisfaction questions will be included. The Patient Knowledge Score was developed from these questions, with a score range of 0 to 10. A higher score on the scale represents better patient knowledge.
Measured: 7-14 days after enrollment
Proper Medication Use (Medication Diary)
Patients medication use will be assessed through a combination of a home medication diary (collected at 7-14 days post enrollment), pill count, and patient report of medication use.
Measured: 10 day medication diary
Current Opioid Misuse Measure (COMM)
Select questions from the Current Opioid Misuse Measure (COMM) will be used to assess if patients are safely taking their prescription opioids.
Measured: 7-14 days after enrollment
Pain Score
Pain scores through structured questions about use in the past 24 hours were collected from participants. Pain Score was assessed on a scale from 0 to 10, where higher numbers represent higher pain scores.
Measured: 7-14 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2017
- Study completionSep 2018
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Opioid Use, UnspecifiedStudies 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
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Danielle McCarthy, Northwestern University
- Investigators
- Danielle McCarthy, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431793
- Sponsor's protocol ID
- 1R18HS023459-01
- Acronym
- EMC2
- Status last verified
- Sep 2019
- First submitted
- 28 Apr 2015
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McCarthy DM, Kim HS, Hur SI, Lank PM, Arroyo C, Opsasnick LA, Piserchia K, Curtis LM, Wolf MS, Courtney DM. Patient-Reported Opioid Pill Consumption After an ED Visit: How Many Pills Are People Using? Pain Med. 2021 Feb 23;22(2):292-302. doi: 10.1093/pm/pnaa048.
PubMed 32219431McCarthy DM, Curtis LM, Courtney DM, Cameron KA, Lank PM, Kim HS, Opsasnick LA, Lyden AE, Gravenor SJ, Russell AM, Eifler MR, Hur SI, Rowland ME, Walton SM, Montague E, Kim KA, Wolf MS. A Multifaceted Intervention to Improve Patient Knowledge and Safe Use of Opioids: Results of the ED EMC2 Randomized Controlled Trial. Acad Emerg Med. 2019 Dec;26(12):1311-1325. doi: 10.1111/acem.13860. Epub 2019 Nov 19.
PubMed 31742823Neill LA, Kim HS, Cameron KA, Lank PM, Patel DA, Hur SI, Opsasnick LA, Curtis LM, Eifler MR, Courtney DM, Wolf MS, McCarthy DM. Who Is Keeping Their Unused Opioids and Why? Pain Med. 2020 Jan 1;21(1):84-91. doi: 10.1093/pm/pnz025.
PubMed 30903661McCarthy DM, Courtney DM, Lank PM, Cameron KA, Russell AM, Curtis LM, Kim KA, Walton SM, Montague E, Lyden AL, Gravenor SJ, Wolf MS. Electronic medication complete communication strategy for opioid prescriptions in the emergency department: Rationale and design for a three-arm provider randomized trial. Contemp Clin Trials. 2017 Aug;59:22-29. doi: 10.1016/j.cct.2017.05.003. Epub 2017 May 4.
PubMed 28479220
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use
- ClinicalTrials.gov ID
- NCT02431793
- Acronym / sponsor ID
- EMC2 / 1R18HS023459-01
- Conditions
- Opioid Use, Unspecified
- Keywords
- Opioids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jul 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Posted 25 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effectiveness of an electronic health record based strategy in promoting safe use of opioid medications after an Emergency Department (ED) visit. The electronic health record (EHR)-based strategy was designed to enhance provider counseling about opioids and to standardize and simplify the information that patients receive.
Detailed description
Research has shown that patients frequently leave the emergency department without sufficient knowledge about how to safely use their newly prescribed opioid pain relievers. Additionally, educational interventions have the ability to increase patient knowledge about medications. In this study, education interventions will be implemented at the level of the EHR and prompt increased provider counseling with a goal of improving patient knowledge and safe use of opioids after ED discharge.
The investigators will conduct a three-arm provider randomized controlled trial among English-speaking adults prescribed hydrocodone-acetaminophen to evaluate the effectiveness of the EMC2 strategy, with and without Short Message Service (SMS) text reminders, to improve patient understanding and safe use of their medication compared to usual care. This study will be conducted at an urban, academic emergency department (annual volume >85,000 patient visits) in Chicago, Illinois. English speaking patients will be recruited and assessed in person at baseline, and by phone at 2-4 days, 7-14 days, and 1 month after recruitment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Employ the standard of care, no intervention |
| EMC2 strategy | Experimental | Behavioral: EMC2 StrategyPatients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids. 1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices. 2. Prescribing instructions will be adapted to the Universal Medication Scheduled Take-Wait-Stop regimen for both the prescribing and dispensing of the medicine. This format uses simplified text and numeric characters to detail dose. 3. Provider counseling prompts: The providers for patients in this arm will be prompted to encourage counseling both in the ED and at follow-up time points. These prompts include: 1) An automated prompt to the ED physician upon signing the order; 2) an automated message to the PCP (if an in-system PCP) notifying them of the ED visit, new prescription, and counseling request; and 3) a request for the pharmacist to counsel patient printed automatically on the prescription. |
| EMC2 strategy + SMS Text Reminders | Experimental | Behavioral: EMC2 Strategy, Behavioral: SMS Text RemindersIn addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To be eligible to enroll and remain in the study, patient subjects must meet all of the following criteria:
Key exclusion criteria (8 listed)
- Subjects will be excluded from the study if any of the following conditions are met:
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 StrategyPatients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language. Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription. | Behavioural | EMC2 strategy, EMC2 strategy + SMS Text Reminders |
| SMS Text RemindersIn addition to the components of the EMC2 strategy arm, patients will received daily text message reminders about the safe use of opioids for 7 days. | Behavioural | EMC2 strategy + SMS Text Reminders |
Primary outcome
Safe Medication Dosing (Prescription Understanding)
Time frame: 7-14 days after enrollment
Patient's ability to demonstrate correctly dosing their prescription opioid-acetaminophen pain reliever will be assessed through a series of questions. Correct dosing will be scored for each medication as yes/no reflecting having demonstrated all of the following: proper dose (# of pills), appropriate spacing (hours between doses), and total daily dose (not exceeding recommended daily dose).
4 secondary outcomes
Medication Knowledge
Time frame: 7-14 days after enrollment
Proper Medication Use (Medication Diary)
Time frame: 10 day medication diary
Current Opioid Misuse Measure (COMM)
Time frame: 7-14 days after enrollment
Pain Score
Time frame: 7-14 days after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32219431McCarthy DM, Kim HS, Hur SI, Lank PM, Arroyo C, Opsasnick LA, Piserchia K, Curtis LM, Wolf MS, Courtney DM. Patient-Reported Opioid Pill Consumption After an ED Visit: How Many Pills Are People Using? Pain Med. 2021 Feb 23;22(2):292-302. doi: 10.1093/pm/pnaa048.
- Derived from this study: PubMed 31742823McCarthy DM, Curtis LM, Courtney DM, Cameron KA, Lank PM, Kim HS, Opsasnick LA, Lyden AE, Gravenor SJ, Russell AM, Eifler MR, Hur SI, Rowland ME, Walton SM, Montague E, Kim KA, Wolf MS. A Multifaceted Intervention to Improve Patient Knowledge and Safe Use of Opioids: Results of the ED EMC2 Randomized Controlled Trial. Acad Emerg Med. 2019 Dec;26(12):1311-1325. doi: 10.1111/acem.13860. Epub 2019 Nov 19.
- Derived from this study: PubMed 30903661Neill LA, Kim HS, Cameron KA, Lank PM, Patel DA, Hur SI, Opsasnick LA, Curtis LM, Eifler MR, Courtney DM, Wolf MS, McCarthy DM. Who Is Keeping Their Unused Opioids and Why? Pain Med. 2020 Jan 1;21(1):84-91. doi: 10.1093/pm/pnz025.
- Derived from this study: PubMed 28479220McCarthy DM, Courtney DM, Lank PM, Cameron KA, Russell AM, Curtis LM, Kim KA, Walton SM, Montague E, Lyden AL, Gravenor SJ, Wolf MS. Electronic medication complete communication strategy for opioid prescriptions in the emergency department: Rationale and design for a three-arm provider randomized trial. Contemp Clin Trials. 2017 Aug;59:22-29. doi: 10.1016/j.cct.2017.05.003. Epub 2017 May 4.
Related trials for Opioid Use, Unspecified
Active, not recruiting
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
Opioid Use, Unspecified, Bariatric Surgery Candidate
RecruitingObservational study
Sensory Outcomes in Active Substance Users
Post Operative Pain, Opioid Use, Unspecified
Active, not recruiting
Patient Utilization of Opioid Destruction Bags in the Post-op Period
Opioid Use, Opioid Use, Unspecified
RecruitingObservational study
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Opioid-use Disorder, Opioid Use, Unspecified
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.
Danielle McCarthy, MD principal investigator
Northwestern University
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 and SMS Text Reminders in people with Opioid Use, Unspecified, 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 6 inclusion and 8 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 25 Sep 2019. 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 25 Sep 2019). 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?
Safe Medication Dosing (Prescription Understanding) (time frame: 7-14 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02431793, which also lists 4 linked publications.
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 25 Sep 2019; AzTrials last refreshed its copy on 30 Oct 2026.