Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-04-26 @ 2:43 AM
Study NCT ID:
NCT02289469
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2014-11-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PictureRx: Improving Medication Safety in Health Disparity Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dane@thinkingmedia.com', 'phone': '(423) 521-2309', 'title': 'Dr. Dane Boyington', 'organization': 'SAI Interactive'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PictureRx', 'description': 'Participants in the intervention group interacted with the PictureRx medication history platform on a tablet computer to provide information about their medications and verify their list of prescribed medications', 'otherNumAtRisk': 244, 'otherNumAffected': 0, 'seriousNumAtRisk': 244, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Patients in the usual care group were matched on a 1:1 basis with intervention patients, on the basis of having received care in the same area of the Emergency Department by the same nurse. Their medication information was collected in the usual fashion by interview.', 'otherNumAtRisk': 244, 'otherNumAffected': 0, 'seriousNumAtRisk': 244, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Changes/Updates in Medication List', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PictureRx', 'description': 'PictureRx medication history platform\n\nPictureRx medication history platform: Tablet PC-based tool to take more complete and accurate medication history'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual medication history process'}], 'classes': [{'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.8', 'ciLowerLimit': '16.0', 'ciUpperLimit': '31.6', 'groupDescription': 'A chi-square test was used to test for differences in proportions between intervention and control groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'Participants for whom nurses made updates or corrections to the medication history in electronic health record', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Understanding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PictureRx', 'description': 'PictureRx medication history platform\n\nPictureRx medication history platform: Tablet PC-based tool to take more complete and accurate medication history'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual medication history process'}], 'classes': [{'categories': [{'title': 'Strongly Disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Neutral', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Agree', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Strongly Agree', 'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'groupDescription': 'Descriptive statistics (counts, frequencies) were used to summarize responses.', 'statisticalMethod': 'Other', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 week', 'description': 'Assessment of patient understanding of their medication regimen using 4 questions:\n\n1. I understand what medicines I am supposed to take.\n2. I understand how much medicine I am supposed to take at a time.\n3. I understand what time of day to take each of my medicines.\n4. I understand what each of my medicines is for. Participants had the following response options: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree Due to formatting restrictions on this site and the results being nearly identical for each question, only answers to question 1 are reported below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A convenience sample of 50 intervention patients was contacted by phone approximately 1 week after Emergency Department discharge to rate their understanding of their medication regimen.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PictureRx', 'description': 'Participants in the intervention group interacted with the PictureRx medication history platform on a tablet computer to provide information about their medications and verify their list of prescribed medications'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Patients in the usual care group were matched on a 1:1 basis with intervention patients, on the basis of having received care in the same area of the Emergency Department by the same nurse. Their medication information was collected in the usual fashion by interview.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '244'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244'}, {'groupId': 'FG001', 'numSubjects': '244'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Unable to match a control', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 250 patients were enrolled into the intervention group. However, only 244 patients could be matched to suitable controls, and 6 were therefore excluded from the analysis of results. Thus the number of patients recruited was 494 (250 intervention + 244 control), but results are presented for 488 (244 intervention + 244 control).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '488', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PictureRx', 'description': 'Participants in the intervention group interacted with the PictureRx medication history platform on a tablet computer to provide information about their medications and verify their list of prescribed medications'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Patients in the usual care group were matched on a 1:1 basis with intervention patients, on the basis of having received care in the same area of the Emergency Department by the same nurse. Their medication information was collected in the usual fashion by interview.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '13', 'groupId': 'BG000'}, {'value': '41', 'spread': '16', 'groupId': 'BG001'}, {'value': '41', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}]}, {'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '488', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ESI acuity level', 'classes': [{'title': '2', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Emergency Severity Index (ESI) is a widely-used triage tool, which Emergency Department nurses use to rate patient acuity and resource needs (range 1-5). Briefly, level 1 patients require immediate life-saving intervention. Level 2 are high-risk, have altered mental status, are in severe pain/distress, or may have certain vital sign abnormalities. Level 3 require many resources. Level 4 require one resource. Level 5 require no additional resources. (See www.esitriage.org for more information.)', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 488}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2014-11-09', 'resultsFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2014-11-12', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-05', 'studyFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Changes/Updates in Medication List', 'timeFrame': '1 day', 'description': 'Participants for whom nurses made updates or corrections to the medication history in electronic health record'}], 'secondaryOutcomes': [{'measure': 'Patient Understanding', 'timeFrame': '1 week', 'description': 'Assessment of patient understanding of their medication regimen using 4 questions:\n\n1. I understand what medicines I am supposed to take.\n2. I understand how much medicine I am supposed to take at a time.\n3. I understand what time of day to take each of my medicines.\n4. I understand what each of my medicines is for. Participants had the following response options: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree Due to formatting restrictions on this site and the results being nearly identical for each question, only answers to question 1 are reported below.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Medication Reconciliation']}, 'descriptionModule': {'briefSummary': "Medication safety is an important concern in hospital Emergency Departments (EDs), which provide approximately 136 million patient visits annually in the US. An accurate list of the patient's medications is often needed to inform medical decision-making. Moreover, health care facilities are required to provide patients with an accurate, reconciled list of their medications upon completion of the visit. However, for 37-87% of patients in the ED, errors are present in the documented medication list, and patients often leave without an updated list of their medications or a good understanding of their self-care instructions. This increases the risk of harmful adverse drug events. Health disparity populations, who are more likely to seek care in EDs and who more often have difficulty providing a complete medication history, are disproportionately affected.\n\nHealth information technology has the potential to improve medication safety in this setting. PictureRx is an internet-based platform designed to improve medication management in vulnerable populations. It allows users to generate illustrated medication lists in an easily-understood, patient-centered format, in either English or Spanish. The investigators have developed a process for importing prescription fill data from the Surescripts Medication History service, which covers 96% of US pharmacies, into the PictureRx platform. The investigators are developing a mobile tablet PC-based medication history platform that receives and processes the Surescripts data, as well as prompts verification and additional information about the medication regimen.\n\nThis trial will assess the effect of the PictureRx medication history platform on the accuracy and efficiency of the medication reconciliation process, as well as patient understanding and satisfaction, in hospital Emergency Departments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prescribed one or more prescription medications\n\nExclusion Criteria:\n\n* Too ill to complete informed consent process'}, 'identificationModule': {'nctId': 'NCT02289469', 'briefTitle': 'PictureRx: Improving Medication Safety in Health Disparity Populations', 'organization': {'class': 'OTHER', 'fullName': 'PictureRx, LLC'}, 'officialTitle': 'PictureRx: Improving Medication Safety in Health Disparity Populations', 'orgStudyIdInfo': {'id': '5R44MD004048-04', 'link': 'https://reporter.nih.gov/quickSearch/5R44MD004048-04', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PictureRx', 'description': 'PictureRx medication history platform', 'interventionNames': ['Other: PictureRx medication history platform']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual medication history process'}], 'interventions': [{'name': 'PictureRx medication history platform', 'type': 'OTHER', 'description': 'Tablet PC-based tool to take more complete and accurate medication history', 'armGroupLabels': ['PictureRx']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnatti', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Dane Boyington, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PictureRx, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PictureRx, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cincinnati', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}