Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-27 @ 8:52 AM
Study NCT ID:
NCT02785458
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2016-04-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Testing a Medication Risk Communication and Surveillance Strategy: The EMC2 Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mswolf@northwestern.edu', 'phone': '312-503-5592', 'title': 'Dr. Michael S. Wolf, PhD MPH', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Subjects will receive the current standard of care.', 'otherNumAtRisk': 526, 'deathsNumAtRisk': 526, 'otherNumAffected': 0, 'seriousNumAtRisk': 526, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EMC2 Strategy', 'description': 'Subjects will receive the EMC2 Strategy. See description of strategy below.\n\nEMC2 Strategy: 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.', 'otherNumAtRisk': 479, 'deathsNumAtRisk': 479, 'otherNumAffected': 0, 'seriousNumAtRisk': 479, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Medication Knowledge (0-100)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Subjects will receive the current standard of care.'}, {'id': 'OG001', 'title': 'EMC2 Strategy', 'description': 'Subjects will receive the EMC2 Strategy. See description of strategy below.\n\nEMC2 Strategy: 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000', 'lowerLimit': '68.5', 'upperLimit': '73.9'}, {'value': '71.9', 'groupId': 'OG001', 'lowerLimit': '68.9', 'upperLimit': '74.8'}]}]}, {'title': '1 Month', 'categories': [{'measurements': [{'value': '73.2', 'groupId': 'OG000', 'lowerLimit': '70.5', 'upperLimit': '75.9'}, {'value': '74.9', 'groupId': 'OG001', 'lowerLimit': '72.0', 'upperLimit': '77.8'}]}]}, {'title': '3 Months', 'categories': [{'measurements': [{'value': '73.2', 'groupId': 'OG000', 'lowerLimit': '70.4', 'upperLimit': '75.9'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '72.0', 'upperLimit': '78.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 3 Months post baseline', 'description': "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", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '127 individuals were excluded from analysis, because their study med was either a short term medication or an antibiotics'}, {'type': 'SECONDARY', 'title': 'Probability of Prescription Medication Proper Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Subjects will receive the current standard of care.'}, {'id': 'OG001', 'title': 'EMC2 Strategy', 'description': 'Subjects will receive the EMC2 Strategy. See description of strategy below.\n\nEMC2 Strategy: 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.'}], 'classes': [{'title': '1 Month', 'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '0.90'}, {'value': '0.81', 'groupId': 'OG001', 'lowerLimit': '0.71', 'upperLimit': '0.88'}]}]}, {'title': '3 Month', 'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '0.90'}, {'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '0.68', 'upperLimit': '0.88'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 Month post baseline to 3 Months post baseline', 'description': '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', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '248 participants were excluded, due to either completing their evaluation early, or not filling their medication'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Subjects will receive the current standard of care.'}, {'id': 'FG001', 'title': 'EMC2 Strategy', 'description': 'Subjects will receive the EMC2 Strategy. See description of strategy below.\n\nEMC2 Strategy: 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.'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '526'}, {'groupId': 'FG001', 'numSubjects': '479'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '526'}, {'groupId': 'FG001', 'numSubjects': '479'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '1 Month', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '526'}, {'groupId': 'FG001', 'numSubjects': '479'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '443'}, {'groupId': 'FG001', 'numSubjects': '404'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '75'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Deemed Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Completed Evaluation by Baseline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Partial Interview', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': '3 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '443'}, {'groupId': 'FG001', 'numSubjects': '404'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '315'}, {'groupId': 'FG001', 'numSubjects': '293'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '111'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Completed Evaluation at 1 Month', 'reasons': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '89'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '1005', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Subjects will receive the current standard of care.'}, {'id': 'BG001', 'title': 'EMC2 Strategy', 'description': 'Subjects will receive the EMC2 Strategy. See description of strategy below.\n\nEMC2 Strategy: 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '1005', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50.34', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '49.5', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '50.0', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '1005', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '319', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '618', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '515', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '978', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Black or African American', 'measurements': [{'value': '304', 'groupId': 'BG000'}, {'value': '372', 'groupId': 'BG001'}, {'value': '676', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Others', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '23 Individuals refused to identify their race, 4 individuals did not know how to identify their race'}, {'title': 'Education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '523', 'groupId': 'BG000'}, {'value': '476', 'groupId': 'BG001'}, {'value': '999', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Less than High School', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}, {'title': 'High School Graduate', 'measurements': [{'value': '292', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '610', 'groupId': 'BG002'}]}, {'title': 'College Graduate', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '5 participants refused to answer the question, 1 did not know their highest education level'}, {'title': 'Self-reported Health Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'BG000'}, {'value': '477', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Excellent/Very Good', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}, {'title': 'Good', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '356', 'groupId': 'BG002'}]}, {'title': 'Fair/Poor', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '4 individuals refused to answer the question'}, {'title': 'Drug Class', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '1005', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Anticonvulsants', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}, {'title': 'Antidepressants', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}, {'title': 'Diabetes', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'LABA', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'NSAID', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'PPI', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Others', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Preferred Language', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '1005', 'groupId': 'BG002'}]}], 'categories': [{'title': 'English', 'measurements': [{'value': '479', 'groupId': 'BG000'}, {'value': '457', 'groupId': 'BG001'}, {'value': '936', 'groupId': 'BG002'}]}, {'title': 'Spanish', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Health Literacy (NVS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'BG000'}, {'value': '388', 'groupId': 'BG001'}, {'value': '806', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Low', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}]}, {'title': 'Marginal', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}, {'title': 'Adequate', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Health Literacy (NVS):Newest Vital Sign', 'unitOfMeasure': 'Participants', 'populationDescription': '174 individuals did not complete the health literacy assessment'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-14', 'size': 174531, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-07-10T13:06', 'hasProtocol': False}, {'date': '2019-10-03', 'size': 972002, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-30T10:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1005}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-06', 'studyFirstSubmitDate': '2016-04-12', 'resultsFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2016-05-26', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-30', 'studyFirstPostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication Knowledge (0-100)', 'timeFrame': 'Baseline to 3 Months post baseline', 'description': "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"}], 'secondaryOutcomes': [{'measure': 'Probability of Prescription Medication Proper Use', 'timeFrame': '1 Month post baseline to 3 Months post baseline', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High-risk Medications']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nThe 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:\n\n1. prompt and guide provider counseling,\n2. automate the delivery of Medication Guides at prescribing,\n3. follow patients post-visit to confirm prescription understanding and use, and\n4. deliver a care alert back to providers to inform them of any potential harms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 21 and older\n* English or spanish speaking\n* Primarily responsible for administering own medications\n* New prescription of one of 66 study medications on day of recruitment\n* Has a personal mobile or land line phone\n\nExclusion Criteria:\n\n* Severe, uncorrectable vision\n* Hearing or cognitive impairments'}, 'identificationModule': {'nctId': 'NCT02785458', 'briefTitle': 'Testing a Medication Risk Communication and Surveillance Strategy: The EMC2 Trial', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Testing a Medication Risk Communication and Surveillance Strategy: The EMC2 Trial', 'orgStudyIdInfo': {'id': 'STU00201638'}, 'secondaryIdInfos': [{'id': '1R01DK103684', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK103684', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Subjects will receive the current standard of care.'}, {'type': 'EXPERIMENTAL', 'label': 'EMC2 Strategy', 'description': 'Subjects will receive the EMC2 Strategy. See description of strategy below.', 'interventionNames': ['Behavioral: EMC2 Strategy']}], 'interventions': [{'name': 'EMC2 Strategy', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['EMC2 Strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Near North Health Services Corporation', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Michael S Wolf, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}, {'name': 'Stacy C Bailey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}, {'name': 'Michael K Paasche-Orlow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Boston Medical Center', 'class': 'OTHER'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Division Chief - Research Division of General Internal Medicine', 'investigatorFullName': 'Michael S. Wolf', 'investigatorAffiliation': 'Northwestern University'}}}}