Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-02 @ 12:46 PM
Study NCT ID:
NCT03661359
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2018-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Social Determinants of Health Screening and Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'heather.klepacz@utoledo.edu', 'phone': '419-383-6754', 'title': 'Heather Klepacz, M.D, Principle Investigator', 'organization': 'University of Toledo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '37days', 'eventGroups': [{'id': 'EG000', 'title': 'Social Determinants of Health', 'description': 'Intervention will be the Social Determinants of Health Referrals.\n\nSocial Determinants of Health Referrals: Patients who screen positive for any of the Social Determinants of Health will be given information for referral to any of the community resources that apply to their situation.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 2, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'death', 'notes': 'patient was a victim of a violent crime', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'death', 'notes': 'patient died at home', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correlation Co-efficient Between Patient Satisfaction Assessed Using HCAHPS and the Domains at Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Social Determinants of Health', 'description': 'Intervention will be the Social Determinants of Health Referrals.\n\nSocial Determinants of Health Referrals: Patients who screen positive for any of the Social Determinants of Health will be given information for referral to any of the community resources that apply to their situation.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.061', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.727', 'groupIds': ['OG000'], 'pValueComment': 'correlation is significant at the 0.05 level (2 tailed)', 'groupDescription': 'Correlation between patient satisfaction and domains at risk.', 'statisticalMethod': 'pearson correlation', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 15 days of discharge', 'description': 'evaluation of patient satisfaction of hospital and staff by patient questionnaire, abbreviated hospital consumer assessment of healthcare providers and system HCAHPS, 9 questions based on positive or negative patient response to hospital care. positive (yes) responses correlate to a 1, negative (no ) responses correlate to a 2. the lower the number correlates to higher hospital satisfaction score. also included a hospital rating of 1-10 with 1 being lowest score and 10 being the highest rating. A higher score correlates to a higher patient satisfaction level. Domains at risk related to social determinants of health', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patients Who Filled Out Community Service Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Social Determinants of Health', 'description': 'Intervention will be the Social Determinants of Health Referrals.\n\nSocial Determinants of Health Referrals: Patients who screen positive for any of the Social Determinants of Health will be given information for referral to any of the community resources that apply to their situation.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days of discharge', 'description': 'During hospital admission each consented patient was assessed for the 5 domains of social determinants of health. Domains are education, economic stability, environment, health/healthcare, and social/community with 11 questions including financial strain, food insecurity, training/employment, housing instability education, utility needs, transportation, childcare, exposure to violence, social connection, behavioral health/substance abuse. A positive (yes) response flagged the patient for a referral to a community service including community financial resources, food banks and kitchens, community employment and training programs, local shelters. adult education programs, utility assistance programs, community transportation programs, community day resources, domestic violence programs, community centers including senior and religious, mental health and substance abuse resources.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'only 1 patient utilized the community resources available after discharge'}, {'type': 'PRIMARY', 'title': 'Correlation Co-efficient Between Physical Quality of Life and Mental Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Social Determinants of Health', 'description': 'Intervention will be the Social Determinants of Health Referrals.\n\nSocial Determinants of Health Referrals: Patients who screen positive for any of the Social Determinants of Health will be given information for referral to any of the community resources that apply to their situation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'pValueComment': 'correlation is significant at the 0.01 level 2 tailed', 'groupDescription': 'correlation between physical quality of life and mental of life', 'statisticalMethod': 'pearson correlation', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'within 30 days of discharge', 'description': 'evaluate the patients perception of their own health with a short form health questionnaire (SF-12).\n\nPhysical component score (PCS-12): A score of 50 or less may indicate a physical condition.\n\nMental component score (MCS-12): A score of 42 or less may indicate clinical depression.\n\nGeneral health: Scores above 50 indicate better-than-average health, while scores below 50 indicate below-average health.\n\nThis compares the physical and mental scores. A correlation coefficient is a statistical measure that indicates the strength and direction of a linear relationship between two variables, expressed as a number between -1 and 1, where -1 signifies a perfect negative correlation, 0 indicates no correlation, and +1 represents a perfect positive correlation; essentially, it tells you how closely two variables are related to each other in a linear fashion.', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Communication Between Patient and Health Care Givers Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Social Determinants of Health', 'description': 'Intervention will be the Social Determinants of Health Referrals.\n\nSocial Determinants of Health Referrals: Patients who screen positive for any of the Social Determinants of Health will be given information for referral to any of the community resources that apply to their situation.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 15 days of discharge', 'description': 'patients will evaluate the communication of the hospital staff with an abbreviated hospital consumer assessment of healthcare providers and system (HCAHPS) and rate the communication. the scale is based on positive (yes) or negative (no) responses. positive (yes) correlates to 1, negative (no) correlates to a 2. This scale of total answers can range from 1 to 10. One being the worst score and 10 being the best score. Once the questionnaire was completed. The negative (no) responses are shared with hospital leadership and unit directors to improve patient/staff communication.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline HCAHPS Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Social Determinants of Health', 'description': 'Intervention will be the Social Determinants of Health Referrals.\n\nSocial Determinants of Health Referrals: Patients who screen positive for any of the Social Determinants of Health will be given information for referral to any of the community resources that apply to their situation.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.061', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.727', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '0.05', 'statisticalMethod': 'pearson correlation', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 15 days of discharge', 'description': 'Baseline data obtained for evaluation of patient satisfaction of hospital and staff by patient questionnaire, abbreviated hospital consumer assessment of healthcare providers and systems, HCAHPS. 10 questions total. 9 based on positive (yes) and negative (no) answers. Positive response (yes) correlates to number 1. negative response (no) correlates to a number 2. The lower the score the greater the patient satisfaction with the hospital. 1 question was a hospital rating scale of 1-10 with 1 being the lowest score and 10 being the highest score. A higher score correlates to a higher patient satisfaction level. A correlation coefficient is a statistical measure that indicates the strength and direction of a linear relationship between two variables, expressed as a number between -1 and 1, where -1 signifies a perfect negative correlation, 0 indicates no correlation, and +1 represents a perfect positive correlation; essentially, it tells you how closely two variables are related to ea', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Social Determinants of Health', 'description': 'Intervention will be the Social Determinants of Health Referrals.\n\nSocial Determinants of Health Referrals: Patients who screen positive for any of the Social Determinants of Health will be given information for referral to any of the community resources that apply to their situation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Social Determinants of Health', 'description': 'Intervention will be the Social Determinants of Health Referrals.\n\nSocial Determinants of Health Referrals: Patients who screen positive for any of the Social Determinants of Health will be given information for referral to any of the community resources that apply to their situation.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '44.97', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '82'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-18', 'size': 195082, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-15T10:25', 'hasProtocol': True}, {'date': '2019-04-08', 'size': 260636, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-11-04T14:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each patient who consents will be given the community resource interventions which apply to them based on the results of the Social Determinants of Health Screening Tool.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2018-06-20', 'resultsFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2018-09-04', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-23', 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Co-efficient Between Patient Satisfaction Assessed Using HCAHPS and the Domains at Risk', 'timeFrame': 'Within 15 days of discharge', 'description': 'evaluation of patient satisfaction of hospital and staff by patient questionnaire, abbreviated hospital consumer assessment of healthcare providers and system HCAHPS, 9 questions based on positive or negative patient response to hospital care. positive (yes) responses correlate to a 1, negative (no ) responses correlate to a 2. the lower the number correlates to higher hospital satisfaction score. also included a hospital rating of 1-10 with 1 being lowest score and 10 being the highest rating. A higher score correlates to a higher patient satisfaction level. Domains at risk related to social determinants of health'}, {'measure': 'Patients Who Filled Out Community Service Questionnaires', 'timeFrame': 'Within 30 days of discharge', 'description': 'During hospital admission each consented patient was assessed for the 5 domains of social determinants of health. Domains are education, economic stability, environment, health/healthcare, and social/community with 11 questions including financial strain, food insecurity, training/employment, housing instability education, utility needs, transportation, childcare, exposure to violence, social connection, behavioral health/substance abuse. A positive (yes) response flagged the patient for a referral to a community service including community financial resources, food banks and kitchens, community employment and training programs, local shelters. adult education programs, utility assistance programs, community transportation programs, community day resources, domestic violence programs, community centers including senior and religious, mental health and substance abuse resources.'}, {'measure': 'Correlation Co-efficient Between Physical Quality of Life and Mental Quality of Life', 'timeFrame': 'within 30 days of discharge', 'description': 'evaluate the patients perception of their own health with a short form health questionnaire (SF-12).\n\nPhysical component score (PCS-12): A score of 50 or less may indicate a physical condition.\n\nMental component score (MCS-12): A score of 42 or less may indicate clinical depression.\n\nGeneral health: Scores above 50 indicate better-than-average health, while scores below 50 indicate below-average health.\n\nThis compares the physical and mental scores. A correlation coefficient is a statistical measure that indicates the strength and direction of a linear relationship between two variables, expressed as a number between -1 and 1, where -1 signifies a perfect negative correlation, 0 indicates no correlation, and +1 represents a perfect positive correlation; essentially, it tells you how closely two variables are related to each other in a linear fashion.'}], 'secondaryOutcomes': [{'measure': 'Communication Between Patient and Health Care Givers Questionnaire', 'timeFrame': 'Within 15 days of discharge', 'description': 'patients will evaluate the communication of the hospital staff with an abbreviated hospital consumer assessment of healthcare providers and system (HCAHPS) and rate the communication. the scale is based on positive (yes) or negative (no) responses. positive (yes) correlates to 1, negative (no) correlates to a 2. This scale of total answers can range from 1 to 10. One being the worst score and 10 being the best score. Once the questionnaire was completed. The negative (no) responses are shared with hospital leadership and unit directors to improve patient/staff communication.'}, {'measure': 'Baseline HCAHPS Data', 'timeFrame': 'Within 15 days of discharge', 'description': 'Baseline data obtained for evaluation of patient satisfaction of hospital and staff by patient questionnaire, abbreviated hospital consumer assessment of healthcare providers and systems, HCAHPS. 10 questions total. 9 based on positive (yes) and negative (no) answers. Positive response (yes) correlates to number 1. negative response (no) correlates to a number 2. The lower the score the greater the patient satisfaction with the hospital. 1 question was a hospital rating scale of 1-10 with 1 being the lowest score and 10 being the highest score. A higher score correlates to a higher patient satisfaction level. A correlation coefficient is a statistical measure that indicates the strength and direction of a linear relationship between two variables, expressed as a number between -1 and 1, where -1 signifies a perfect negative correlation, 0 indicates no correlation, and +1 represents a perfect positive correlation; essentially, it tells you how closely two variables are related to ea'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Social Determinants of Health', 'Patient Satisfaction', 'Quality of Life']}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to connect patients with community resources to improve social determinants of health. Secondary objectives are improving patient satisfaction within the trauma and general surgery service, enhancement of physician-patient communication, betterment of surgery department Hospital Consumer Assessment of Healthcare Providers and Systems scores, and increased understanding of correlations between patient satisfaction and social determinants of health.\n\nThe investigators hypothesize that (1) directed screening and intervention can have a positive effect for patients and hospitals, (2) directed patient advocacy will have an effect on patients' perception of care, (2) social determinants of health will have an effect on patients' perception of care, and (4) traumatic injury and acute surgery will have an effect on patients' perception of care.", 'detailedDescription': "The investigators will be conducting this study as a prospective, non-randomized quality improvement study that will look at patients 18 years of age and older who are admitted under the trauma and general surgery specialties. Patients will be identified through admission to the trauma or general surgery service or referred to surgery services.\n\nEligible patients will be identified and approached by the study team. Once the informed consent is completed, patients will be given a Social Determinants of Health Screening Tool, an Hospital Consumer Assessment of Healthcare Providers and Systems Feedback Tool, and an short form health survey (SF-12) Quality of Life Questionnaire. Feedback from the Hospital Consumer Assessment of Healthcare Providers and Systems results will be given immediately to the relevant teams (nurses, doctors, etc.) to address the patient's concerns. Prior to discharge, the patients will also be given referrals to designated community resources. On day 15 (+/- 7 days) after discharge, the patients will receive a follow up phone call where they will be asked if they have utilized the Social Determinants of Health Referrals. Participants will also be given a second Hospital Consumer Assessment of Healthcare Providers and Systems Feedback Survey at this time. On day 30 (+/- 7 days) after discharge, the patients will receive a follow up phone call where the participants will be asked if they utilized the Social Determinants of Health Referrals. Participants will also be given a second short form health survey (SF-12) Quality of Life Survey at this time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Admitted to the trauma or general surgery services\n* Live within Lucas County (for county referrals)\n* Patient or legally authorized representative agrees to participate and is willing to sign informed consent\n\nExclusion Criteria:\n\n* Anyone less than 18 years old\n* Any patient or legally authorized representative unwilling to sign informed consent\n* Anyone who lives outside of Lucas County or expresses unwillingness to use referral services'}, 'identificationModule': {'nctId': 'NCT03661359', 'acronym': 'SDOH', 'briefTitle': 'Social Determinants of Health Screening and Interventions', 'organization': {'class': 'OTHER', 'fullName': 'University of Toledo'}, 'officialTitle': 'Patient Perceptions of Care: The Effects of Social Determinants of Health', 'orgStudyIdInfo': {'id': 'SDOH Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Social Determinants of Health', 'description': 'Intervention will be the Social Determinants of Health Referrals.', 'interventionNames': ['Other: Social Determinants of Health Referrals']}], 'interventions': [{'name': 'Social Determinants of Health Referrals', 'type': 'OTHER', 'description': 'Patients who screen positive for any of the Social Determinants of Health will be given information for referral to any of the community resources that apply to their situation.', 'armGroupLabels': ['Social Determinants of Health']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Toledo Medical Center', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}], 'overallOfficials': [{'name': 'Heather Klepacz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toledo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data collection is still in early stages. Further discussion will be needed before a decision is finalized.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toledo Health Science Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}