Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-28 @ 12:02 AM
Study NCT ID:
NCT02431793
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2015-04-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'd-mccarthy2@northwestern.edu', 'phone': '312-926-7532', 'title': 'Dr. Danielle McCarthy', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 day', 'description': 'revisit resulting in admission or ICU care related to their prescribed opioid/acetaminophen (acetaminophen overdose, opioid overdose)', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Employ the standard of care, no intervention', 'otherNumAtRisk': 202, 'deathsNumAtRisk': 202, 'otherNumAffected': 0, 'seriousNumAtRisk': 202, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EMC2 Strategy', 'description': 'Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.\n\n1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices.\n2. 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.\n3. 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 on the prescription.', 'otherNumAtRisk': 243, 'deathsNumAtRisk': 243, 'otherNumAffected': 0, 'seriousNumAtRisk': 243, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'EMC2 Strategy + SMS Text Reminders', 'description': 'In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.\n\nEMC2 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.\n\nShort 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.', 'otherNumAtRisk': 207, 'deathsNumAtRisk': 207, 'otherNumAffected': 0, 'seriousNumAtRisk': 207, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safe Medication Dosing (Prescription Understanding)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Employ the standard of care, no intervention'}, {'id': 'OG001', 'title': 'EMC2 Strategy', 'description': 'Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.\n\n1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices.\n2. 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.\n3. 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 on the prescription.'}, {'id': 'OG002', 'title': 'EMC2 Strategy + SMS Text Reminders', 'description': 'In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.\n\nEMC2 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.\n\nShort 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'groupId': 'OG000', 'lowerLimit': '0.55', 'upperLimit': '0.77'}, {'value': '0.83', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '0.89'}, {'value': '0.79', 'groupId': 'OG002', 'lowerLimit': '0.69', 'upperLimit': '0.87'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '7-14 days after enrollment', 'description': "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).", 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Medication Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Employ the standard of care, no intervention'}, {'id': 'OG001', 'title': 'EMC2 Strategy', 'description': 'Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.\n\n1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices.\n2. 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.\n3. 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 on the prescription.'}, {'id': 'OG002', 'title': 'EMC2 Strategy + SMS Text Reminders', 'description': 'In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.\n\nEMC2 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.\n\nShort 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.48', 'groupId': 'OG000', 'lowerLimit': '5.13', 'upperLimit': '5.84'}, {'value': '5.46', 'groupId': 'OG001', 'lowerLimit': '5.16', 'upperLimit': '5.75'}, {'value': '6.06', 'groupId': 'OG002', 'lowerLimit': '5.71', 'upperLimit': '6.41'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '7-14 days after enrollment', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Proper Medication Use (Medication Diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Employ the standard of care, no intervention'}, {'id': 'OG001', 'title': 'EMC2 Strategy', 'description': 'Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.\n\n1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices.\n2. 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.\n3. 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 on the prescription.'}, {'id': 'OG002', 'title': 'EMC2 Strategy + SMS Text Reminders', 'description': 'In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.\n\nEMC2 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.\n\nShort 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.40', 'upperLimit': '0.63'}, {'value': '0.66', 'groupId': 'OG001', 'lowerLimit': '0.56', 'upperLimit': '0.75'}, {'value': '0.65', 'groupId': 'OG002', 'lowerLimit': '0.54', 'upperLimit': '0.75'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '10 day medication diary', 'description': '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.', 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Current Opioid Misuse Measure (COMM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Employ the standard of care, no intervention'}, {'id': 'OG001', 'title': 'EMC2 Strategy', 'description': 'Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.\n\n1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices.\n2. 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.\n3. 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 on the prescription.'}, {'id': 'OG002', 'title': 'EMC2 Strategy + SMS Text Reminders', 'description': 'In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.\n\nEMC2 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.\n\nShort 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000', 'lowerLimit': '0.58', 'upperLimit': '0.79'}, {'value': '0.78', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '0.85'}, {'value': '0.71', 'groupId': 'OG002', 'lowerLimit': '0.60', 'upperLimit': '0.81'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '7-14 days after enrollment', 'description': 'Select questions from the Current Opioid Misuse Measure (COMM) will be used to assess if patients are safely taking their prescription opioids.', 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Employ the standard of care, no intervention'}, {'id': 'OG001', 'title': 'EMC2 Strategy', 'description': 'Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.\n\n1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices.\n2. 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.\n3. 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 on the prescription.'}, {'id': 'OG002', 'title': 'EMC2 Strategy + SMS Text Reminders', 'description': 'In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.\n\nEMC2 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.\n\nShort 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.76', 'groupId': 'OG000', 'lowerLimit': '2.21', 'upperLimit': '3.31'}, {'value': '2.47', 'groupId': 'OG001', 'lowerLimit': '2.01', 'upperLimit': '2.94'}, {'value': '2.60', 'groupId': 'OG002', 'lowerLimit': '2.03', 'upperLimit': '3.17'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '7-14 days after enrollment', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Employ the standard of care, no intervention'}, {'id': 'FG001', 'title': 'EMC2 Strategy', 'description': '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.\n\n1. A single-page medication information sheet with content from a patients perspective, following health literacy best practices.\n2. Prescribing instructions will be adapted to the Universal Medication Scheduled Take-Wait-Stop regimen for both prescribing and dispensing of the medicine. This format uses simplified text and numeric characters to detail dose.\n3. 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 in-system PCP) notifying them of ED visit, new prescription, and counseling request; and 3) a request for the pharmacist to counsel patient printed automatically on the prescription.'}, {'id': 'FG002', 'title': 'EMC2 Strategy + SMS Text Reminders', 'description': 'In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.\n\nEMC2 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.\n\nSMS 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '243'}, {'groupId': 'FG002', 'numSubjects': '207'}]}, {'type': 'Completed T1 (3-5 Days Post Enrollment)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '180'}, {'groupId': 'FG002', 'numSubjects': '143'}]}, {'type': 'Completed T2 (7-14 Days Post Enrollment)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '141'}, {'groupId': 'FG002', 'numSubjects': '107'}]}, {'type': 'Completed T3 (30 Days Post Enrollment)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '117'}]}], 'dropWithdraws': [{'type': 'Ineligible doe to not filling Rx', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '122'}, {'groupId': 'FG002', 'numSubjects': '104'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}, {'value': '652', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Employ the standard of care, no intervention'}, {'id': 'BG001', 'title': 'EMC2 Strategy', 'description': 'Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.\n\n1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices.\n2. 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.\n3. 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 on the prescription.'}, {'id': 'BG002', 'title': 'EMC2 Strategy + SMS Text Reminders', 'description': 'In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.\n\nEMC2 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.\n\nShort 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.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}, {'value': '652', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '43.3', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '42.3', 'spread': '14.4', 'groupId': 'BG001'}, {'value': '41.3', 'spread': '13.3', 'groupId': 'BG002'}, {'value': '42.2', 'spread': '14.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}, {'value': '652', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '372', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '280', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}, {'value': '650', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '305', 'groupId': 'BG003'}]}, {'title': 'African American', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two individuals refused to identify their race, so the total population analyzed for race was 650 as opposed to 652.'}, {'title': 'Health Literacy (NVS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}, {'value': '652', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Limited/Marginal Literacy', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}]}, {'title': 'Adequate Literacy', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '433', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Income', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}, {'value': '582', 'groupId': 'BG003'}]}], 'categories': [{'title': '< $40,000', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}]}, {'title': '$40,000-$100,000', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '202', 'groupId': 'BG003'}]}, {'title': '>$100,000', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '202', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '70 individuals refused to/felt uncomfortable identifying their income, so the total population analyzed for income was 582 as opposed to 652.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-11', 'size': 496271, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-12T12:39', 'hasProtocol': True}, {'date': '2019-06-07', 'size': 65727, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-09-23T15:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 652}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-23', 'studyFirstSubmitDate': '2015-04-28', 'resultsFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2015-04-30', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-23', 'studyFirstPostDateStruct': {'date': '2015-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safe Medication Dosing (Prescription Understanding)', 'timeFrame': '7-14 days after enrollment', 'description': "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)."}], 'secondaryOutcomes': [{'measure': 'Medication Knowledge', 'timeFrame': '7-14 days after enrollment', 'description': '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.'}, {'measure': 'Proper Medication Use (Medication Diary)', 'timeFrame': '10 day medication diary', 'description': '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.'}, {'measure': 'Current Opioid Misuse Measure (COMM)', 'timeFrame': '7-14 days after enrollment', 'description': 'Select questions from the Current Opioid Misuse Measure (COMM) will be used to assess if patients are safely taking their prescription opioids.'}, {'measure': 'Pain Score', 'timeFrame': '7-14 days after enrollment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Opioids'], 'conditions': ['Opioid Use, Unspecified']}, 'referencesModule': {'references': [{'pmid': '32219431', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '31742823', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30903661', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '28479220', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be eligible to enroll and remain in the study, patient subjects must meet all of the following criteria:\n\n 1. Patient age 18 years and older\n 2. English language speaking\n 3. prescribed pill form of hydrocodone-acetaminophen opioid pain reliever\n 4. own a cell phone with text messaging capabilities\n 5. the patient is the person primarily responsible for administering medication\n\nExclusion Criteria:\n\n* Subjects will be excluded from the study if any of the following conditions are met:\n\n 1. Aged \\<18\n 2. non-English speaking\n 3. clinically unstable, psychologically impaired or intoxicated as judged by research staff member or emergency physician\n 4. chronic opioid use, defined as daily or near daily use of opioid pain relievers for the past 90 days\n 5. admitted to hospital\n 6. unable to complete follow up phone interviews\n 7. pregnant'}, 'identificationModule': {'nctId': 'NCT02431793', 'acronym': 'EMC2', 'briefTitle': 'EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use', 'orgStudyIdInfo': {'id': '1R18HS023459-01', 'link': 'https://reporter.nih.gov/quickSearch/1R18HS023459-01', 'type': 'AHRQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Employ the standard of care, no intervention'}, {'type': 'EXPERIMENTAL', 'label': 'EMC2 strategy', 'description': 'Patients of providers randomized to EMC2 arm will received educational tool from the ED to support the understanding and safe use of opioids.\n\n1. A single-page medication information sheet with content from a patients perspective and following health literacy best practices.\n2. 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.\n3. 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.', 'interventionNames': ['Behavioral: EMC2 Strategy']}, {'type': 'EXPERIMENTAL', 'label': 'EMC2 strategy + SMS Text Reminders', 'description': 'In addition to the EMC2 Strategy Arm, patients will received daily text message reminders about the safe use of opioids for 7 days.', 'interventionNames': ['Behavioral: EMC2 Strategy', 'Behavioral: SMS Text Reminders']}], 'interventions': [{'name': 'EMC2 Strategy', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['EMC2 strategy', 'EMC2 strategy + SMS Text Reminders']}, {'name': 'SMS Text Reminders', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['EMC2 strategy + SMS Text Reminders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Danielle McCarthy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University Feinberg School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Emergency Medicine', 'investigatorFullName': 'Danielle McCarthy', 'investigatorAffiliation': 'Northwestern University'}}}}