Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-31 @ 5:14 PM
Study NCT ID:
NCT03810534
Status:
COMPLETED
Last Update Posted:
2022-08-23
First Post:
2019-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Connect-Home Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mtoles@email.unc.edu', 'phone': '919-966-5684', 'title': 'Mark Toles, MPH', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.', 'description': 'Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Connect-Home Patients', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.", 'otherNumAtRisk': 165, 'deathsNumAtRisk': 165, 'otherNumAffected': 0, 'seriousNumAtRisk': 165, 'deathsNumAffected': 6, 'seriousNumAffected': 38}, {'id': 'EG001', 'title': 'Connect-Home Caregivers', 'description': 'Caregivers of Connect-Home study patients.', 'otherNumAtRisk': 165, 'deathsNumAtRisk': 165, 'otherNumAffected': 0, 'seriousNumAtRisk': 165, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Patients', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'deathsNumAffected': 8, 'seriousNumAffected': 34}, {'id': 'EG003', 'title': 'Control Caregivers', 'description': 'Caregivers of Control study patients.', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Hospitalization for generalized weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Reason Undisclosed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for Racing Heart Issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for Neck Laceration Caused by Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to Mini Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to Kidney Issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Acute Metabolic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Low Blood Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Fluid Build-Up', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Left Thoracentesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Fracture Subsequent to Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Gall Bladder Issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Cardiac Stent Placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Colon Tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Lower Extremity Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Tremors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Toe Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Leg Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Due to Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Connect-Home', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge."}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge'}], 'classes': [{'categories': [{'measurements': [{'value': '75.80', 'spread': '16.08', 'groupId': 'OG000'}, {'value': '68.33', 'spread': '17.69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.62', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.24', 'estimateComment': 'The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '7 Days After SNF Discharge', 'description': "The patient's preparedness for discharge will be measured by the Care Transitions Measure-15 (CTM-15), which includes 5 items on a 4-point scale. The CTM-15 measures self-reported knowledge and skills for continuing care at home. Summary score range 0-100, with higher scores associated with less acute care use after discharge.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data reported for participants who answered the 7-day data collection phone call.'}, {'type': 'PRIMARY', 'title': "Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge", 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Connect-Home', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge."}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge'}], 'classes': [{'categories': [{'measurements': [{'value': '23.14', 'spread': '6.74', 'groupId': 'OG000'}, {'value': '19.26', 'spread': '6.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.31', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.44', 'estimateComment': 'The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '7 Days After Patient SNF Discharge', 'description': "The caregiver's preparedness for caregiving will be measured by the Preparedness for Caregiving Scale (PCS), which includes 8 items on a five-point Likert scale (0-4). The PCS measures self-reported readiness for caregiving. Range = 0-32, with higher scores associated with less anxiety.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Connect-Home', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge."}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge'}], 'classes': [{'categories': [{'measurements': [{'value': '7.69', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '7.69', 'spread': '1.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.93', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.33', 'estimateComment': 'The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 Days After SNF Discharge', 'description': "The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Connect-Home', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge."}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge'}], 'classes': [{'categories': [{'measurements': [{'value': '7.81', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '7.71', 'spread': '1.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.60', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.34', 'estimateComment': 'The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '60 Days After SNF Discharge', 'description': "The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Life Space Assessment 30 Days After Skilled Nursing Facility Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Connect-Home', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge."}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge'}], 'classes': [{'categories': [{'measurements': [{'value': '22.18', 'spread': '16.67', 'groupId': 'OG000'}, {'value': '22.97', 'spread': '15.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.53', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.49', 'estimateComment': 'The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 Days After SNF Discharge', 'description': 'Patient\'s function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the "Life-space level" (range 1-5) and the "independence" score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Life Space Assessment 60 Days After Skilled Nursing Facility Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Connect-Home', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge."}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge'}], 'classes': [{'categories': [{'measurements': [{'value': '25.55', 'spread': '17.41', 'groupId': 'OG000'}, {'value': '28.60', 'spread': '18.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.83', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.57', 'estimateComment': 'The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '60 Days After SNF Discharge', 'description': 'Patient\'s function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the "Life-space level" (range 1-5) and the "independence" score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Connect-Home', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge."}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge'}], 'classes': [{'categories': [{'measurements': [{'value': '12.27', 'spread': '9.77', 'groupId': 'OG000'}, {'value': '12.33', 'spread': '10.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.75', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.05', 'estimateComment': 'The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': "30 Days After Patient's SNF Discharge", 'description': 'Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that "caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning." Scores range 0-48; higher scores are associated with depression and social isolation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Connect-Home', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge."}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge'}], 'classes': [{'categories': [{'measurements': [{'value': '11.84', 'spread': '9.40', 'groupId': 'OG000'}, {'value': '11.35', 'spread': '8.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.50', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.07', 'estimateComment': 'The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': "60 Days After Patient's SNF Discharge", 'description': 'Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that "caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning." Scores range 0-48; higher scores are associated with depression and social isolation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Distress Thermometer 30 Days After Skilled Nursing Facility Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Connect-Home', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge."}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge'}], 'classes': [{'categories': [{'measurements': [{'value': '3.19', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '3.02', 'spread': '3.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.48', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.50', 'estimateComment': 'The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': "30 Days After Patient's SNF Discharge", 'description': 'Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores \\>4 associated with poor coping and depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Distress Thermometer 60 Days After Skilled Nursing Facility Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Connect-Home', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge."}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge'}], 'classes': [{'categories': [{'measurements': [{'value': '3.03', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '2.60', 'spread': '2.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.52', 'estimateComment': 'The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': "60 Days After Patient's SNF Discharge", 'description': 'Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores \\>4 associated with poor coping and depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Connect-Home', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge."}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '.65', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '3.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.88', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean ratio', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.25', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 Days After SNF Discharge', 'description': "Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the Emergency Department (ED) or hospital in 30 days after SNF discharge.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are reported only for participants who had acute care use.'}, {'type': 'SECONDARY', 'title': 'Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Connect-Home', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge."}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '.82', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '3.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean ratio', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.18', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '60 Days After SNF Discharge', 'description': "Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the ED or hospital in 60 days after SNF discharge.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are reported only for participants who had acute care use.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SNF 1', 'description': 'Connect-Home intervention at skilled nursing facility (SNF) 1.\n\nParticipants at this SNF enter the Standard of Care phase for 5 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 11 months.\n\nParticipants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.'}, {'id': 'FG001', 'title': 'SNF 2', 'description': 'Connect-Home intervention at skilled nursing facility (SNF) 2.\n\nParticipants at this SNF enter the Standard of Care phase for 6 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 10 months.\n\nParticipants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.'}, {'id': 'FG002', 'title': 'SNF 3', 'description': 'Connect-Home intervention at skilled nursing facility (SNF) 3.\n\nParticipants at this SNF enter the Standard of Care phase for 7 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 9 months.\n\nParticipants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.'}, {'id': 'FG003', 'title': 'SNF 4', 'description': 'Connect-Home intervention at skilled nursing facility (SNF) 4.\n\nParticipants at this SNF enter the Standard of Care phase for 8 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 8 months.\n\nParticipants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.'}, {'id': 'FG004', 'title': 'SNF 5', 'description': 'Connect-Home intervention at skilled nursing facility (SNF) 5.\n\nParticipants at this SNF enter the Standard of Care phase for 9 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 7 months.\n\nParticipants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.'}, {'id': 'FG005', 'title': 'SNF 6', 'description': 'Connect-Home intervention at skilled nursing facility (SNF) 6.\n\nParticipants at this SNF enter the Standard of Care phase for 10 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 6 months.\n\nParticipants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.'}], 'periods': [{'title': 'Standard of Care (5-10 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '62'}, {'groupId': 'FG004', 'numSubjects': '34'}, {'groupId': 'FG005', 'numSubjects': '88'}]}, {'type': 'Patients Started', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '44'}]}, {'type': 'Caregivers Started', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '44'}]}, {'type': 'Completed 7-day (Patients)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '40'}]}, {'type': 'Completed 7-Day (Caregivers)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'Completed 30-day (Patients)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'Completed 30-Day (Caregivers)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '32'}]}, {'type': 'Completed 60-Day (Patients)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '32'}]}, {'type': 'Completed 60-Day (Caregivers)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '25'}]}]}, {'title': 'Pre-Implementation Phase (2 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Patients Started', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Caregivers Started', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Completed 7-Day (Patients)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Completed 7-Day (Caregivers)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Completed 30-Day (Patients)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Completed 30-Day (Caregivers)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Completed 60-Day (Patients)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Completed 60-Day (Caregivers)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Connect-Home (5-10 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'Patients Started', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '19'}]}, {'type': 'Caregivers Started', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '19'}]}, {'type': 'Completed 7-Day (Patients)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '14'}]}, {'type': 'Completed 7-Day (Caregivers)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '13'}]}, {'type': 'Completed 30-Day (Patients)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'Completed 30-Day (Caregivers)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'Completed 60-Day (Patients)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'Completed 60-Day (Caregivers)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '38'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '19'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}, {'value': '654', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Connect-Home Patients', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge."}, {'id': 'BG001', 'title': 'Connect-Home Caregivers', 'description': 'Caregivers of Connect-Home study patients.'}, {'id': 'BG002', 'title': 'Control Patients', 'description': 'Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.'}, {'id': 'BG003', 'title': 'Control Caregivers', 'description': 'Caregivers of Control study patients.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.5', 'spread': '9.49', 'groupId': 'BG000'}, {'value': '58.1', 'spread': '14.02', 'groupId': 'BG001'}, {'value': '76.6', 'spread': '9.55', 'groupId': 'BG002'}, {'value': '60.9', 'spread': '13.72', 'groupId': 'BG003'}, {'value': '76.5', 'spread': '9.51', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}, {'value': '444', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '210', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}, {'value': '654', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '157', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}, {'value': '472', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}, {'value': '654', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-13', 'size': 554245, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-17T13:07', 'hasProtocol': True}, {'date': '2019-01-30', 'size': 161121, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-05-02T14:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The Connect-Home study employs a stepped wedge cluster-randomized trial design, which is a crossover design at the cluster level where clusters of individuals (i.e., residents in a nursing home) crossover from control to intervention condition at randomly assigned timepoints or steps.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 654}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-29', 'studyFirstSubmitDate': '2019-01-17', 'resultsFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2019-01-17', 'lastUpdatePostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-29', 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge', 'timeFrame': '7 Days After SNF Discharge', 'description': "The patient's preparedness for discharge will be measured by the Care Transitions Measure-15 (CTM-15), which includes 5 items on a 4-point scale. The CTM-15 measures self-reported knowledge and skills for continuing care at home. Summary score range 0-100, with higher scores associated with less acute care use after discharge."}, {'measure': "Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge", 'timeFrame': '7 Days After Patient SNF Discharge', 'description': "The caregiver's preparedness for caregiving will be measured by the Preparedness for Caregiving Scale (PCS), which includes 8 items on a five-point Likert scale (0-4). The PCS measures self-reported readiness for caregiving. Range = 0-32, with higher scores associated with less anxiety."}], 'secondaryOutcomes': [{'measure': 'McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge', 'timeFrame': '30 Days After SNF Discharge', 'description': "The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means."}, {'measure': 'McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge', 'timeFrame': '60 Days After SNF Discharge', 'description': "The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means."}, {'measure': 'Life Space Assessment 30 Days After Skilled Nursing Facility Discharge', 'timeFrame': '30 Days After SNF Discharge', 'description': 'Patient\'s function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the "Life-space level" (range 1-5) and the "independence" score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.'}, {'measure': 'Life Space Assessment 60 Days After Skilled Nursing Facility Discharge', 'timeFrame': '60 Days After SNF Discharge', 'description': 'Patient\'s function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the "Life-space level" (range 1-5) and the "independence" score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.'}, {'measure': 'Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge', 'timeFrame': "30 Days After Patient's SNF Discharge", 'description': 'Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that "caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning." Scores range 0-48; higher scores are associated with depression and social isolation.'}, {'measure': 'Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge', 'timeFrame': "60 Days After Patient's SNF Discharge", 'description': 'Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that "caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning." Scores range 0-48; higher scores are associated with depression and social isolation.'}, {'measure': 'Distress Thermometer 30 Days After Skilled Nursing Facility Discharge', 'timeFrame': "30 Days After Patient's SNF Discharge", 'description': 'Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores \\>4 associated with poor coping and depression.'}, {'measure': 'Distress Thermometer 60 Days After Skilled Nursing Facility Discharge', 'timeFrame': "60 Days After Patient's SNF Discharge", 'description': 'Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores \\>4 associated with poor coping and depression.'}, {'measure': 'Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge', 'timeFrame': '30 Days After SNF Discharge', 'description': "Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the Emergency Department (ED) or hospital in 30 days after SNF discharge."}, {'measure': 'Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge', 'timeFrame': '60 Days After SNF Discharge', 'description': "Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the ED or hospital in 60 days after SNF discharge."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transitional Care', 'Skilled Nursing Facilities'], 'conditions': ['Transitional Care', 'Caregivers', 'Patient Discharge', 'Aging', 'Frailty']}, 'referencesModule': {'references': [{'pmid': '33546737', 'type': 'DERIVED', 'citation': 'Toles M, Colon-Emeric C, Hanson LC, Naylor M, Weinberger M, Covington J, Preisser JS. Transitional care from skilled nursing facilities to home: study protocol for a stepped wedge cluster randomized trial. Trials. 2021 Feb 5;22(1):120. doi: 10.1186/s13063-021-05068-0.'}]}, 'descriptionModule': {'briefSummary': 'This study will test whether transitional care targeting care needs of seriously ill, skilled nursing facility (SNF) patients and their caregivers will help to improve SNF patient outcomes (preparedness for discharge, quality of life, function and acute care use) and caregiver outcomes (preparedness for the caregiving role. caregiver burden and caregiver distress).', 'detailedDescription': "Prior research has not established an evidence-based model of transitional care for seriously ill SNF patients (and their caregivers) who transfer from SNF to home-based care. Connect-Home, the intervention to be tested in this study, will use existing nursing home staff and community-based nurses to deliver transitional care in SNFs and the patient's home.\n\nThe feasibility, acceptability, and estimated efficacy of Connect-Home was demonstrated in a pilot test of pre-discharge elements of Connect-Home (N=133 patients and their caregivers). Compared to controls, intervention participants were significantly more prepared for discharge (higher scores on Care Transitions Measure-15) and they more frequently received individualized plans for continuing care at home. Virtually all SNF staff participants (97%) recommended the intervention for future use, demonstrating its acceptability. The objective of this study is to test the efficacy of Connect-Home for seriously ill patients discharged to home and their caregivers.\n\nIn this trial, intervention participants will receive the Connect-Home intervention; the intervention has two steps. While the patient is in the SNF, nurses, social workers and rehabilitation therapists will create an individualized Transition Plan of Care and prepare the patient and caregiver to manage the patient's serious illness at home. Within 24 hours of the time that the SNF patient discharges to home, a Connect-Home Activation Nurse (Activation RN) will visit the patient at home; the Activation RN will help the patient and family caregiver implement the written Transition Plan of Care. The Connect-Home intervention will focus on six key care needs: (1) home safety and level of assistance; (2) advance care planning; (3) symptom management; (4) medication reconciliation; (5) function and activity; and (6) coordination of follow-up medical care. In this trial, the control participants will receive usual discharge planning in the SNF only. Usual discharge planning for SNF patients includes assignment to an interdisciplinary team that develops discharge instructions for the patient to follow at home with oversight by a physician. Usual care does not include a structured home visit after the patient discharges to home.\n\nPatient and caregiver outcomes will assessed in 7, 30, and 60 days after the patient discharged from the SNF to home. Outcomes assessors will be blinded to study group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for patients:\n\n* English-speaking\n* Have a Minimum Data Set 3.0 Section GG Mobility Assessment Score of 3 or less, indicating the patient requires at least 25-50% assistance for functional mobility\n* Be diagnosed with at least 1 serious medical illness (neurodegenerative dementia, cancer, chronic kidney disease, cirrhosis, congestive heart failure, chronic obstructive or interstitial lung disease, acute infection with sepsis, acute major motor stroke, acute coronary syndrome, acute hip fracture, diabetes with end organ complications, or intensive care for \\>3 days while hospitalized)\n* Having a caregiver who can be enrolled in the study\n* For patients with cognitive impairment additional criteria include documentation in the medical record of a caregiver who is the patient's legally authorized representative; and consent of the caregiver to participate in the study as the patient's representative.\n\nInclusion Criteria for Caregivers:\n\n* English-speaking\n* Self-reports assisting the patient at home.\n\nExclusion Criteria for Patients:\n\n* Planned hospital readmission for procedures/treatments in next 90 days.\n\nThere are no exclusion criteria for Caregivers."}, 'identificationModule': {'nctId': 'NCT03810534', 'briefTitle': 'Connect-Home Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Connect-Home: Testing the Efficacy of Transitional Care of Patients and Caregivers During Transitions From Skilled Nursing Facilities to Home', 'orgStudyIdInfo': {'id': '18-1513'}, 'secondaryIdInfos': [{'id': 'R01NR017636', 'link': 'https://reporter.nih.gov/quickSearch/R01NR017636', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Connect-Home', 'description': "Connect-Home intervention at the skilled nursing facility and at the subject's home.", 'interventionNames': ['Behavioral: Connect-Home']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard discharge planning at the skilled nursing facility only.'}], 'interventions': [{'name': 'Connect-Home', 'type': 'BEHAVIORAL', 'description': "Connect-Home will introduce organizational structure to support delivery of transitional care processes. New elements of structure include:electronic health record (EHR) template, Connect-Home Toolkit, and Staff Training. After structural elements are added, SNF staff will use Connect-Home care processes to deliver the 2-step transitional care intervention.In Step 1, SNF nurses, therapists, and social workers will develop a Transition Plan of Care and prepare the patient and caregiver to manage the patient's serious illness and functional needs. In Step 2, the Connect-Home Activation RN will visit the patient's home within 24 hours of discharge; the nurse will activate the Transition Plan of Care at home. Both intervention steps focus on 6 key care needs to optimize patient and caregiver outcomes: 1) home safety and level of assistance; 2) advance care planning; 3) symptom management; 4) medication reconciliation; 5) function and activity; and 6) coordination of follow-up medical care.", 'armGroupLabels': ['Connect-Home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC-Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Mark Toles, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '9 to 36 months following publication.', 'ipdSharing': 'YES', 'description': 'Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.', 'accessCriteria': 'Investigators who propose to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and must execute a data use/sharing agreement with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}