Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-02-27 @ 7:20 PM
Study NCT ID:
NCT02959866
Status:
COMPLETED
Last Update Posted:
2019-09-27
First Post:
2016-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Implementation and Impact of an Online Tool Used in Primary Care to Improve Income Security
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012934', 'term': 'Social Isolation'}, {'id': 'D062487', 'term': 'Social Marginalization'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rucchettoa@smh.ca', 'phone': '416-864-6060', 'title': 'Anne Rucchetto, Research Coordinator', 'phoneExt': '76155', 'organization': "St. Michael's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Online Income Tool', 'description': 'Patients who complete the online income tool with their health provider during the study period.\n\nonline income tool: An online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Awareness of Financial Benefits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Income Tool', 'description': 'Patients who finished using the tool with their healthcare providers and produced a PDF of recommended benefits that they may have been eligible to apply for.\n\nonline income tool: An online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'Self-reported awareness of at least one financial benefit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This the the number of people who used the tool to completion with their healthcare provider'}, {'type': 'SECONDARY', 'title': 'Increase in Income', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Income Tool', 'description': 'Patients who complete the online income tool with their health provider during the study period and were reached for an interview at 1 month follow-up.\n\nOnline income tool: An online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'Self-reported increase in income through accessing a financial benefit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Online Income Tool', 'description': 'Patients who complete the online income tool with their health provider during the study period and were enrolled in the study through participation in the evaluation.\n\nOnline income tool: An online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'Telephone Interview at 1 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Clinicians will be encouraged to screen patients for poverty and use the online tool with every eligible patient during 3-months. It is difficult to estimate how many patients will be seen during the 3-month time period, the number who will be living in poverty, the number who agree to the intervention and be consented to the study for follow-up.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Online Income Tool', 'description': 'Patients who were reached for follow-up at one month, after using the Online income tool with their healthcare provider: 59\n\nonline income tool: An online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'We did not collect information about age during our follow-up interviews with participants.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'We did not collect data on sex.', 'unitOfMeasure': 'Participants', 'populationDescription': 'We did not collect information on gender from those reached for follow-up interviews.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Whether participants have trouble making ends meet at the end of the month', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This is the sample of people who were enrolled in this research by participating in one-month follow-up interviews after using the tool with their healthcare provider.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-14', 'size': 552320, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-19T14:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-26', 'studyFirstSubmitDate': '2016-11-07', 'resultsFirstSubmitDate': '2018-08-13', 'studyFirstSubmitQcDate': '2016-11-07', 'lastUpdatePostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-26', 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Awareness of Financial Benefits', 'timeFrame': '4 weeks', 'description': 'Self-reported awareness of at least one financial benefit'}], 'secondaryOutcomes': [{'measure': 'Increase in Income', 'timeFrame': '4 weeks', 'description': 'Self-reported increase in income through accessing a financial benefit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Social Determinants of Health', 'Poverty', 'Social Isolation', 'Social Marginalization']}, 'referencesModule': {'references': [{'pmid': '29061603', 'type': 'BACKGROUND', 'citation': 'Aery A, Rucchetto A, Singer A, Halas G, Bloch G, Goel R, Raza D, Upshur REG, Bellaire J, Katz A, Pinto AD. Implementation and impact of an online tool used in primary care to improve access to financial benefits for patients: a study protocol. BMJ Open. 2017 Oct 22;7(10):e015947. doi: 10.1136/bmjopen-2017-015947.'}]}, 'descriptionModule': {'briefSummary': 'We will evaluate the acceptability, feasibility and impact of an online tool that helps patients identify financial benefits that they are entitled to at six clinic sites over a three month period. We will answer the following questions: Is an online tool that addresses income security feasible and acceptable to clinicians? Can such a tool be integrated into regular clinic workflow? What is the patient perspective on the tool and what is the short-term impact?', 'detailedDescription': 'Addressing the social determinants of health of patients has been identified as a key way to achieve health system goals. However, few evidence-based interventions exist. This study emerges from an ongoing collaboration between family physicians, researchers and a charitable financial literacy organization. This study aims to answer the following questions: Is an online tool that addresses income security feasible and acceptable to clinicians? Can such a tool be integrated into regular clinic workflow? What is the patient perspective on the tool and what is the short-term impact? We will recruit six primary care sites in Toronto and Winnipeg that serve low-income communities. We will introduce clinicians to screening for poverty and increasing access to additional income sources via government benefits. Following an initial orientation session, health providers will be encouraged to use the tool with any patient seen. The health provider and patient will complete the online tool together, generating a tailored list of financial benefits, along with local community resources to assist with obtaining these benefits. A brief survey on this experience will be administered to patients after they complete the tool, as well as a request to contact them in one month. Those who agree to be contacted will be interviewed on whether the intervention impacted their knowledge and ability to access benefits. We will administer an online survey to providers and conduct provider focus groups at each site at the end of study. An advisory group made up of patients living on low incomes and representatives from community agencies will support this study. An online tool could help health providers in improving the income security of their patients. Strengths of this study include that it involves a diverse set of clinics and that the tool has been implemented pragmatically, in the real world of busy primary care clinics. Limitations include the convenience sampling method, that the selected clinics may not be representative of all primary care providers and the relatively short follow-up period. Our findings will provide insight into the potential of electronic tools that assist providers address the social determinants of health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Used the online income tool with their health provider\n* Able to provide consent\n* Able to converse in English\n* Able to be reached by telephone or email\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT02959866', 'briefTitle': 'Implementation and Impact of an Online Tool Used in Primary Care to Improve Income Security', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Evaluating the Implementation and Impact of an Online Tool Used Within Primary Care to Improve the Income Security of Patients With Complex Health and Social Needs in Ontario and Manitoba', 'orgStudyIdInfo': {'id': 'SMH2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online income tool', 'description': 'Patients who complete the online income tool with their health provider during the study period.', 'interventionNames': ['Other: online income tool']}], 'interventions': [{'name': 'online income tool', 'type': 'OTHER', 'otherNames': ['benefits screening tool'], 'description': 'An online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for.', 'armGroupLabels': ['Online income tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3E 3P5', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Department of Family Medicine, Faculty of Medicine, University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'M5B1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Andrew D Pinto, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}