Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT03050918
Status:
COMPLETED
Last Update Posted:
2019-07-29
First Post:
2017-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Discharge Follow-up Phone Call Program
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maya.yiadom@vumc.org', 'phone': '615-936-0087', 'title': 'Maame Yaa Yiadom', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'A data lag due to limited national electronic health record informatics connectivity prevents us from tracking adverse events documented outside of our facility. Unmeasured outcomes should be equally distributed between the randomized groups.'}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': "Adverse Events were evaluated in 3 ways: 1) all-cause mortality, 2) reviewing a 10% sample of the Phone Call Nurse's daily reports, and 3) reviewing the Phone Call Program office's internal quality assessment for evidence the intervention may introduce harm.", 'eventGroups': [{'id': 'EG000', 'title': 'Phone Call Group (Intervention Arm)', 'description': "Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care.", 'otherNumAtRisk': 1534, 'deathsNumAtRisk': 1534, 'otherNumAffected': 0, 'seriousNumAtRisk': 1534, 'deathsNumAffected': 68, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care Group (Control Arm)', 'description': 'Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.', 'otherNumAtRisk': 1520, 'deathsNumAtRisk': 1520, 'otherNumAffected': 0, 'seriousNumAtRisk': 1520, 'deathsNumAffected': 75, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With In-patient Re-admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1534', 'groupId': 'OG000'}, {'value': '1520', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phone Call Group (Intervention Arm)', 'description': "Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care."}, {'id': 'OG001', 'title': 'Usual Care Group (Control Arm)', 'description': 'Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.'}], 'classes': [{'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "we used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with in-patient re-admissions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction: Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phone Call Group (Intervention Arm)', 'description': "Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care."}, {'id': 'OG001', 'title': 'Usual Care Group (Control Arm)', 'description': 'Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Within 60 days of Discharge', 'description': 'Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Higher scores indicate more patient satisfaction. Range is 0-9 with 9 being the most satisfied.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient experience data were retrieved from the hospital quality and patient safety office at 60 days, but assessment was administered via a survey sent to patients at their home after hospital discharge. Scores are based on the number of surveys returned'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction: Likelihood to Recommend the Facility (Top Box Rating)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phone Call Group (Intervention Arm)', 'description': "Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care."}, {'id': 'OG001', 'title': 'Usual Care Group (Control Arm)', 'description': 'Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.'}], 'classes': [{'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 60 days of Discharge', 'description': 'Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Number of patients that reported a score of 3. Range is 0-3 with 3 being highest satisfaction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient experience data were retrieved from the hospital quality and patient safety office at 60 days, but assessment was administered via a survey sent to patients at their home after hospital discharge. Scores are based on the number of surveys returned.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction: Hospital Experience (Top Box Rating)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phone Call Group (Intervention Arm)', 'description': "Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care."}, {'id': 'OG001', 'title': 'Usual Care Group (Control Arm)', 'description': 'Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.'}], 'classes': [{'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 60 days of Discharge', 'description': 'Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Number of patients that rated the Hospital Experience as 9. Scale range is 0-9. Higher scores indicate more patient satisfaction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient experience data were retrieved from the hospital quality and patient safety office at 60 days, but assessment was administered via a survey sent to patients at their home after hospital discharge. Scores are based on the number of surveys returned'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction: Likelihood to Recommend the Facility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phone Call Group (Intervention Arm)', 'description': "Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care."}, {'id': 'OG001', 'title': 'Usual Care Group (Control Arm)', 'description': 'Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '.7', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Within 60 days of Discharge', 'description': 'Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Scale range is 0-3. Higher scores indicate more patient satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient experience data were retrieved from the hospital quality and patient safety office at 60 days, but assessment was administered via a survey sent to patients at their home after hospital discharge. Scores are based on the number of surveys returned'}, {'type': 'SECONDARY', 'title': 'VUMC Emergency Department (ED) Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1534', 'groupId': 'OG000'}, {'value': '1520', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phone Call Group (Intervention Arm)', 'description': "Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care."}, {'id': 'OG001', 'title': 'Usual Care Group (Control Arm)', 'description': 'Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'All cause ED visits following discharge', 'unitOfMeasure': 'ED visits', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patient Received Discharge Plan Implementation Assistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1534', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phone Call Group (Intervention Arm)', 'description': "Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care."}, {'id': 'OG001', 'title': 'Usual Care Group (Control Arm)', 'description': 'Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.'}], 'classes': [{'categories': [{'measurements': [{'value': '463', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Need for assistance in implementing discharge plan', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Discharge plan implementation assistance was offered as part of the intervention and not to the control group.'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1534', 'groupId': 'OG000'}, {'value': '1520', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phone Call Group (Intervention Arm)', 'description': "Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care."}, {'id': 'OG001', 'title': 'Usual Care Group (Control Arm)', 'description': 'Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'All cause mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Thirty-day mortality data was retrieved from the EHR data repository after a 120-day lag to capture delayed reporting.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phone Call Group (Intervention Arm)', 'description': "Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care."}, {'id': 'FG001', 'title': 'Usual Care Group (Control Arm)', 'description': 'Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1534'}, {'groupId': 'FG001', 'numSubjects': '1520'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1534'}, {'groupId': 'FG001', 'numSubjects': '1520'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1534', 'groupId': 'BG000'}, {'value': '1520', 'groupId': 'BG001'}, {'value': '3054', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Phone Call Group (Intervention Arm)', 'description': "Follow-up Phone Call Program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care."}, {'id': 'BG001', 'title': 'Usual Care Group (Control Arm)', 'description': 'Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '17.7', 'groupId': 'BG000'}, {'value': '53.4', 'spread': '18.1', 'groupId': 'BG001'}, {'value': '52.9', 'spread': '17.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '761', 'groupId': 'BG000'}, {'value': '749', 'groupId': 'BG001'}, {'value': '1510', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '773', 'groupId': 'BG000'}, {'value': '771', 'groupId': 'BG001'}, {'value': '1544', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '323', 'groupId': 'BG000'}, {'value': '314', 'groupId': 'BG001'}, {'value': '637', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1164', 'groupId': 'BG000'}, {'value': '1158', 'groupId': 'BG001'}, {'value': '2322', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1534', 'groupId': 'BG000'}, {'value': '1520', 'groupId': 'BG001'}, {'value': '3054', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Highest Education/grade completed', 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '12.9', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '13.07', 'spread': '3.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grade level in years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Brief Health Literacy Score', 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '12.0', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '11.91', 'spread': '3.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measures health literacy and patients ability to act as an independent agent for their own medical care. A score of \\<10 is considered to be inadequate to act alone as an independent agent for their own medical care and can identify patients that need assistance. Total score can range from 3 (low health literacy) to 15 (high health literacy).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Established Primary Care Provider', 'classes': [{'categories': [{'measurements': [{'value': '982', 'groupId': 'BG000'}, {'value': '1018', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hospital Length of Stay', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '4.6', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '4.54', 'spread': '4.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Any time on Intensive Care Unit during stay', 'classes': [{'categories': [{'measurements': [{'value': '281', 'groupId': 'BG000'}, {'value': '308', 'groupId': 'BG001'}, {'value': '589', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Predicted Re-admission risk before discharge', 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '15.9', 'groupId': 'BG000'}, {'value': '23.4', 'spread': '14.2', 'groupId': 'BG001'}, {'value': '23.9', 'spread': '15.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Predicted Readmission Risk Before Discharge is the result of a real-time predictive model embedded and displayed in the Vanderbilt Adult Hospital's electronic health record (EHR). It was developed through a collaboration between the Medical Center's Office of Quality Safety and Risk Prevention and the Vanderbilt Institute for Clinical and Translational Research and embedded into the EHR. The range for the predicted readmission risk is 0-100 (percent). Higher numbers indicate higher risk of re-admission.", 'unitOfMeasure': 'percent risk', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'In-patient Admission in prior 6 months', 'classes': [{'categories': [{'measurements': [{'value': '483', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '944', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mean number of In-Patient admissions in the prior 6 months', 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '0.6', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '0.6', 'spread': '1.184', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'in-patient admissions', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CMS Re-admission Penalty Group: COPD Exacerbation', 'classes': [{'categories': [{'measurements': [{'value': '320', 'groupId': 'BG000'}, {'value': '327', 'groupId': 'BG001'}, {'value': '647', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CMS Re-admission Penalty Group: Pneumonia', 'classes': [{'categories': [{'measurements': [{'value': '384', 'groupId': 'BG000'}, {'value': '371', 'groupId': 'BG001'}, {'value': '755', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CMS Re-admission Penalty Group: Heart Failure', 'classes': [{'categories': [{'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '468', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CMS Re-admission Penalty Group: Acute Myocardial Infarction', 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CMS Re-admission Penalty Group: Stroke', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CMS Re-admission Penalty Group: Total hip/knee', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Re-admission for Elective Primary Total Hip Arthroplasty and/or Total Knee Arthroplasty (THA/TKA)', 'unitOfMeasure': 'Participants'}, {'title': 'CMS Re-admission Penalty Group: Coronary Artery Bypass Graph', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CMS Re-admission Penalty Group: None', 'classes': [{'categories': [{'measurements': [{'value': '836', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1661', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-05', 'size': 788436, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-23T08:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a single center, pragmatic, randomized, controlled clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3054}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-26', 'studyFirstSubmitDate': '2017-02-09', 'resultsFirstSubmitDate': '2019-03-07', 'studyFirstSubmitQcDate': '2017-02-09', 'lastUpdatePostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-26', 'studyFirstPostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With In-patient Re-admissions', 'timeFrame': '30 days', 'description': 'Number of participants with in-patient re-admissions'}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction: Experience', 'timeFrame': 'Within 60 days of Discharge', 'description': 'Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Higher scores indicate more patient satisfaction. Range is 0-9 with 9 being the most satisfied.'}, {'measure': 'Patient Satisfaction: Likelihood to Recommend the Facility (Top Box Rating)', 'timeFrame': 'Within 60 days of Discharge', 'description': 'Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Number of patients that reported a score of 3. Range is 0-3 with 3 being highest satisfaction.'}, {'measure': 'Patient Satisfaction: Hospital Experience (Top Box Rating)', 'timeFrame': 'Within 60 days of Discharge', 'description': 'Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Number of patients that rated the Hospital Experience as 9. Scale range is 0-9. Higher scores indicate more patient satisfaction.'}, {'measure': 'Patient Satisfaction: Likelihood to Recommend the Facility', 'timeFrame': 'Within 60 days of Discharge', 'description': 'Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Scale range is 0-3. Higher scores indicate more patient satisfaction.'}, {'measure': 'VUMC Emergency Department (ED) Visits', 'timeFrame': '30 days', 'description': 'All cause ED visits following discharge'}, {'measure': 'Number of Patient Received Discharge Plan Implementation Assistance', 'timeFrame': '30 days', 'description': 'Need for assistance in implementing discharge plan'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'All cause mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Discharge Follow-up Phone Calls']}, 'referencesModule': {'references': [{'pmid': '32732787', 'type': 'DERIVED', 'citation': 'Yiadom MYAB, Domenico HJ, Byrne DW, Hasselblad M, Kripalani S, Choma N, Tucker-Marlow S, Gatto CL, Wang L, Bhatia MC, Morrison J, Harrell FE, Hartert TV, Lindsell CJ, Bernard GR. Impact of a Follow-up Telephone Call Program on 30-Day Readmissions (FUTR-30): A Pragmatic Randomized Controlled Real-world Effectiveness Trial. Med Care. 2020 Sep;58(9):785-792. doi: 10.1097/MLR.0000000000001353.'}, {'pmid': '29444787', 'type': 'DERIVED', 'citation': 'Yiadom MYAB, Domenico H, Byrne D, Hasselblad MM, Gatto CL, Kripalani S, Choma N, Tucker S, Wang L, Bhatia MC, Morrison J, Harrell FE, Hartert T, Bernard G. Randomised controlled pragmatic clinical trial evaluating the effectiveness of a discharge follow-up phone call on 30-day hospital readmissions: balancing pragmatic and explanatory design considerations. BMJ Open. 2018 Feb 14;8(2):e019600. doi: 10.1136/bmjopen-2017-019600.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this project is to quantify the impact of post-hospital discharge follow-up phone calls on hospital readmission, ED visits, patient satisfaction, and mortality in a general medicine inpatient population. We will obtain exploratory information on patient sub-groups at high risk for hospital readmission and on those experiencing high benefit from the follow-up phone call intervention. In addition, we will obtain data on discharge plan implementation assistance needed to support a successful transition from inpatient to outpatient care among those reached by the intervention phone call.', 'detailedDescription': "RATIONALE\n\nIn the current medical literature, it is unclear how follow-up calls influence these outcomes in a general medical population. Some studies have attempted to address this question, but are limited in that they target very specific patient populations, are of insufficient quality, or evaluated follow-up calls as part of a larger care bundle. We will conduct a high quality, real-time clinical care study to determine the efficacy of a follow-up phone call program.\n\nSTUDY DESIGN\n\nThis is a single center, pragmatic, randomized, controlled clinical trial to investigate whether a structured post-hospital discharge follow-up phone call can improve patients' transition from in-hospital to outpatient care and improve satisfaction with their care. We will also identify the discharge implementation assistance given to those in the intervention (Phone Call) group.\n\nOutcome Measures Primary outcome for this study is readmission event rate within 30 days. Secondary outcomes include patient satisfaction which will be measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores, all cause VUMC emergency department (ED) visits, the need for assistance with discharge plan implementation, and 30 day mortality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* VUMC patients discharged after an inpatient status hospital stay on a general medicine service.\n\nExclusion Criteria:\n\n* patients who experience in-hospital death\n* patient discharged to any post-acute care facility or inpatient hospice\n* left the hospital against medical advice'}, 'identificationModule': {'nctId': 'NCT03050918', 'acronym': 'FUTR-30', 'briefTitle': 'Discharge Follow-up Phone Call Program', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'A Pragmatic, Randomized, Controlled Trial Examining the Effectiveness of a Hospital Discharge Follow-up Phone Call Program', 'orgStudyIdInfo': {'id': '170019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Phone Call Group (Intervention Arm)', 'description': "Follow-up phone call intervention: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care.", 'interventionNames': ['Behavioral: Follow-up Phone Call']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care Group (Control Arm)', 'description': 'Patients assigned to the control group receive standard discharge planning and follow-up per the usual care of their medical providers.'}], 'interventions': [{'name': 'Follow-up Phone Call', 'type': 'BEHAVIORAL', 'description': 'Patients will receive a first call attempt within 72 hours discharge.', 'armGroupLabels': ['Phone Call Group (Intervention Arm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Maame Yaa Yiadom, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The study protocol was published in BMJ Open in 2017 (Yiadom MYAB, Domenico H, Byrne D, et al Randomised controlled pragmatic clinical trial evaluating the effectiveness of a discharge follow-up phone call on 30-day hospital readmissions: balancing pragmatic and explanatory design considerations BMJ Open 2018;8:e019600. doi: 10.1136/bmjopen-2017-019600)\n\nA full de-identified version of the database including participate data for this study will be available to other investigators upon request after consideration of their proposed use for the data. We are happy to begin accepting requests starting 12 months following the publication of the manuscript including study results.', 'ipdSharing': 'YES', 'description': 'The study protocol, semi-structured intervention script, randomization code, data flow design have been published to share with other investigators.\n\nIndividual study data will be available to other investigators upon request per details below.', 'accessCriteria': 'All requests should be directed to the corresponding author (maya.yiadom@vumc.org).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MPH, MSCI, Assistant Professor', 'investigatorFullName': 'Maame Yaa A. B. Yiadom', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}