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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMC2 Strategy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 7-14 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
To be eligible to enroll and remain in the study, patient subjects must meet all of the following criteria:
Exclusion Criteria:
Subjects will be excluded from the study if any of the following conditions are met:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle McCarthy, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32219431 | Derived | 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. | |
| 31742823 | Derived | McCarthy 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Employ the standard of care, no intervention |
| FG001 | EMC2 Strategy | Patients of providers randomized to EMC2 arm will receive educational tool from the Emergency Department (ED) to support the understanding and safe use of opioids.
|
| FG002 | EMC2 Strategy + SMS Text Reminders | In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days. EMC2 Strategy: Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) a single-page medication information sheet 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 electronic health record (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 Reminders: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Employ the standard of care, no intervention |
| BG001 | EMC2 Strategy | Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The population for this analysis includes anyone who completed the demonstrated dosing task at T2 (7-14 days post enrollment). The reported results represent the predicted probability of correctly demonstrating dosing, adjusting for health literacy and physician inter-correlation. | Posted | Least Squares Mean | 95% Confidence Interval | probability | 7-14 days after enrollment |
|
30 day
revisit resulting in admission or ICU care related to their prescribed opioid/acetaminophen (acetaminophen overdose, opioid overdose)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Employ the standard of care, no intervention | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Danielle McCarthy | Northwestern University | 312-926-7532 | d-mccarthy2@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2016 | Aug 12, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2019 | Sep 23, 2019 | SAP_001.pdf |
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|
| SMS Text Reminders | Behavioral | 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. |
|
| 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. | 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. | 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. | 7-14 days after enrollment |
| 30903661 | Derived | Neill 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. |
| 28479220 | Derived | McCarthy 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. |
| Lost to Follow-up |
|
| BG002 | EMC2 Strategy + SMS Text Reminders | In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days. EMC2 Strategy: 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. Short Message Service (SMS) Text Reminders: 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652. | Count of Participants | Participants |
|
| Health Literacy (NVS) | Count of Participants | Participants |
|
| Income | 70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652. | Count of Participants | Participants |
|
| OG001 | EMC2 Strategy | Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.
|
| OG002 | EMC2 Strategy + SMS Text Reminders | In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days. EMC2 Strategy: 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. Short Message Service (SMS) Text Reminders: 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. |
|
|
| Secondary | 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. | The population for this analysis includes anyone who answered the knowledge questions at T2 (7-14 days post enrollment). The reported results represent the mean knowledge score (0-10), adjusting for health literacy, income, race and physician inter-correlation. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 7-14 days after enrollment |
|
|
|
| Secondary | 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. | The population for this analysis includes anyone who returned their medication diary with medication information filled out. The reported results represent the predicted probability of correctly using medication (without errors), adjusting for physician inter-correlation. | Posted | Least Squares Mean | 95% Confidence Interval | probability | 10 day medication diary |
|
|
|
| Secondary | 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. | The population for this analysis includes anyone who answered select COMM questions at T2 (7-14 days post enrollment). The reported results represent those who safely took their opioid medications, adjusting for health literacy, income, race and physician inter-correlation. | Posted | Least Squares Mean | 95% Confidence Interval | probability | 7-14 days after enrollment |
|
|
|
| Secondary | 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. | The population for this analysis includes anyone who answered the pain score questions at T2 (7-14 days post enrollment). The reported results represent the mean pain score (0-10), adjusting for health literacy, income, race and physician inter-correlation. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 7-14 days after enrollment |
|
|
|
| 202 |
| 0 |
| 202 |
| 0 |
| 202 |
| EG001 | EMC2 Strategy | Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.
| 0 | 243 | 0 | 243 | 0 | 243 |
| EG002 | EMC2 Strategy + SMS Text Reminders | In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days. EMC2 Strategy: 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. Short Message Service (SMS) Text Reminders: 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. | 0 | 207 | 0 | 207 | 0 | 207 |
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| Male |
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| African American |
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| Other |
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| Adequate Literacy |
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| $40,000-$100,000 |
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| >$100,000 |
|