[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06118983":3,"trial-entities:NCT06118983":135,"trial-summary:NCT06118983":138},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":35,"secondary_outcomes":63,"sex":87,"minimum_age":88,"maximum_age":89,"healthy_volunteers":15,"eligibility_criteria":90,"std_ages":96,"locations":99,"central_contacts":124,"overall_officials":127,"references":129,"see_also_links":134},"NCT06118983","23-06026204","Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF)","Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF): A Type 1 Hybrid Effectiveness- Implementation Trial","RECRUITING","2028-07-01","2026-08","2026-08-21","2026-07-28","Weill Medical College of Cornell University","OTHER",true,"This study is trying to improve the hospital-to-home transition for people with heart failure who receive home care services. The study will test an intervention called I-TRANSFER-HF, which differs from usual care by combining early home health nurse visits and outpatient medical appointments.\n\nThe study is interested in two questions:\n\n1. Is I-TRANSFER-HF better than usual care at preventing heart failure patients from returning to the hospital within 30 days?\n2. Are there parts of I-TRANSFER-HF that are easy or hard to implement in the real world?\n\nThe researchers will answer these questions by testing the intervention among pairs of hospitals and home health agencies across the country. During the study, the hospital-agency pairs will be asked to implement I-TRANSFER-HF. The researchers will then compare the results from before and after I-TRANSFER-HF was adopted. They will also interview people from these hospitals and agencies to see how I-TRANSFER-HF is being implemented under real-world conditions.","The investigators' will test two hypotheses:\n\nHypothesis 1 (H1): Compared to usual care, adults with heart failure who receive the I-TRANSFER-HF intervention will have fewer 30-day readmissions, ED visits, and greater days at home. The four hospital-agency pairs will all begin the study with a baseline period of no intervention and then randomly selected to start the intervention phase at different points in time. Medicare claims data from each hospital-agency pair will be used to determine outcomes, and these data will be supplemented with national claims data for external controls not in the study to test the effectiveness of the I-TRANSFER-HF intervention.\n\nHypothesis 2 (H2): Compared to usual care, heart failure patients who receive I-TRANSFER-HF will have a higher proportion of timely first week HHC nursing visits (within 2 days of hospital discharge, plus 2 more) and outpatient visits (within 7-days of discharge). Given the rise of telemedicine, the study will test the association between the type of outpatient visit (in-person vs. virtual), its timing, and its association with outcomes. H2 requires conducting qualitative interviews with key stakeholders across the 4 hospital-agency pairs to identify barriers and facilitators that influence I-TRANSFER-HF's implementation. The study will assess the intervention's acceptability, feasibility, fidelity, and adaptation with interviews and Medicare claims data using a multi-methods approach and guided by the updated Consolidated Framework for Implementation Research (CFIR 2.0).",[19],"Heart Failure",[21,22],"home health care","hospital-to-home transition","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[26],"NA",{"count":28,"type":29},1094,"ESTIMATED",[31],{"type":14,"name":32,"description":33,"armGroupLabels":34},"I-TRANSFER-HF","I-TRANSFER-HF is comprised of early and intensive HHC nurse visits and an outpatient visit within 7 days of discharge. Using a Hybrid Type 1, stepped wedge randomized trial design, we will test the effectiveness and implementation of I-TRANSFER-HF in partnership with 4 geographically diverse dyads of hospitals and HHC agencies (\"hospital-HHC agency\" dyads) across the US.",[32],[36,40,44,47,50,53,56,60],{"measure":37,"description":38,"timeFrame":39},"All-cause 30-day hospital readmission","All-cause 30-day hospital readmission among adults hospitalized for heart failure who receive home health care after discharge and receive the I-TRANSFER-HF protocol compared to usual care, as assessed by Medicare claims","30 days following post-Index HF Hospitalization",{"measure":41,"description":42,"timeFrame":43},"Number of Eligible patients","Number of heart failure patients eligible to receive I-TRANSFER-HF as assessed by Medicare claims data","12 months",{"measure":45,"description":46,"timeFrame":43},"Number of Eligible Patients Who Received Protocol Components","Number of heart failure patients who received both components of I-TRANSFER-HF (front-loaded home health nurse visits and early outpatient medical follow-up), one, or none as assessed by Medicare claims data",{"measure":48,"description":49,"timeFrame":43},"Modality of outpatient follow-up","The modality of outpatient follow-up received (in-person vs. virtual visit) as assessed by Medicare claims data",{"measure":51,"description":52,"timeFrame":43},"Timeliness of Post-Hospital Discharge Home Health Nursing Evaluation","The timeliness of first-week nursing visits within 2 days of hospital discharge as assessed by Medicare claims data",{"measure":54,"description":55,"timeFrame":43},"Timeliness of Post-Hospital Outpatient Follow-Up","The timeliness of outpatient visits within 7 days of hospital discharge as assessed by Medicare claims data",{"measure":57,"description":58,"timeFrame":59},"Feasibility of implementing I-TRANSFER-HF (Qualitative Interviews)","Feasibility will be assessed through qualitative interviews with site stakeholders","30 days after intervention (year of intervention)",{"measure":61,"description":62,"timeFrame":59},"Feasibility of implementing I-TRANSFER-HF (Surveys)","Feasibility will be measured through the completion of the validated, 4-item, Feasibility of Intervention Measure (FIM). Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). The score is calculated as the mean. The scale for this measure ranges from 4-20 with higher scores indicating greater perceived feasibility of the intervention.",[64,68,72,75,78,81,84],{"measure":65,"description":66,"timeFrame":67},"All-cause 30-day ED visits","All-cause 30-day emergency department visits among adults hospitalized for heart failure who receive home health care after discharge and receive the I-TRANSFER-HF protocol compared to usual care, as assessed by Medicare claims data","30 days following post-Index heart failure Hospitalization.",{"measure":69,"description":70,"timeFrame":71},"Days at home among adults hospitalized for heart failure who receive home health care after discharge and receive the I-TRANSFER-HF protocol compared to usual care, as assessed by Medicare claims","Days at home will be calculated as 365 days minus the number of inpatient days in an acute care facility, an inpatient rehabilitation facility, a skilled nursing facility, or an inpatient hospice unit.","During a 12-month period (year of intervention)",{"measure":73,"description":74,"timeFrame":59},"Acceptability of I-TRANSFER-HF - Qualitative Interviews","Acceptability will be assessed through qualitative interviews.",{"measure":76,"description":77,"timeFrame":59},"Acceptability of Intervention Measure for the I-TRANSFER-HF Study - Survey","Acceptability will be assessed through the 4-item, validated, Acceptability of Intervention Measure (AIM). Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). The score is calculated as the mean. The scale for this measure ranges from 4-20 with higher scores indicating greater perceived acceptability of the intervention.",{"measure":79,"description":80,"timeFrame":59},"Fidelity of I-TRANSFER-HF (Participant-Completed)","Fidelity will be assessed by extent to which I-TRANSFER-HF is implemented by the study site teams. Fidelity will be measured using participant-completed fidelity checklists. These checklists will be developed during the implementation process.",{"measure":82,"description":83,"timeFrame":59},"Fidelity of I-TRANSFER-HF (Observational Ratings)","Fidelity will be assessed by extent to which I-TRANSFER-HF is implemented by the study site teams. Fidelity will be measured using observational fidelity ratings conducted by site champions. These checklists will be developed during the implementation process.",{"measure":85,"description":86,"timeFrame":59},"Adaptation of I-TRANSFER-HF","Adaptation will be assessed with qualitative interviews to document how the intervention was modified and refined during the study period.","ALL","18 Years",null,{"inclusion":91,"exclusion":93,"raw_text":95},[92],"Adults hospitalized for HF who transition from participating hospitals to their partner HHC agency during the study period.",[94],"Patients hospitalized for HF and discharged: home without HHC, or to an inpatient rehabilitation facility, skilled nursing facility, or hospice; patients with end stage renal disease on dialysis and those with left ventricular devices.","Aim 1, Inclusion Criteria:\n\n* Adults hospitalized for HF who transition from participating hospitals to their partner HHC agency during the study period.\n\nAim 1, Exclusion Criteria:\n\n* Patients hospitalized for HF and discharged: home without HHC, or to an inpatient rehabilitation facility, skilled nursing facility, or hospice; patients with end stage renal disease on dialysis and those with left ventricular devices.\n\nAim 2, Inclusion Criteria:\n\n\\- Healthcare professional involved in the transition of heart failure patients from the acute care setting (hospital) to HHC (home health care) agencies, and the implementation of the I-TRANSFER-HF at one of the four participating hospital-HHC dyads.\n\nAim 2, Exclusion Criteria:\n\n\\- Healthcare professional not involved in the transition of heart failure patients from the acute care setting (hospital) to HHC (home health care) agencies, and the implementation of the I-TRANSFER-HF at one of the four participating hospital-HHC dyads.",[97,98],"ADULT","OLDER_ADULT",[100,113],{"facility":101,"status":8,"city":102,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":110},"VNS Health Partners in Care","New York","10017","United States",[106],{"name":107,"role":108,"email":109},"Kathy Bowles, PhD, RN,FAAN","CONTACT","bowles@nursing.upenn.edu",{"lat":111,"lon":112},40.71427,-74.00597,{"facility":114,"status":8,"city":102,"state":102,"zip":115,"country":104,"contacts":116,"geoPoint":123},"Weill Cornell Medicine","10021",[117,121],{"name":118,"role":108,"phone":119,"email":120},"Madeline R Sterling, MD, MPH, MS","646-962-5029","mrs9012@med.cornell.edu",{"name":118,"role":122},"PRINCIPAL_INVESTIGATOR",{"lat":111,"lon":112},[125],{"name":118,"role":108,"phone":126,"email":120},"6469625029",[128],{"name":118,"affiliation":13,"role":122},[130],{"pmid":131,"type":132,"citation":133},"39354472","DERIVED","Sterling MR, Espinosa CG, Spertus D, Shum M, McDonald MV, Ryvicker MB, Barron Y, Tobin JN, Kern LM, Safford MM, Banerjee S, Goyal P, Ringel JB, Rajan M, Arbaje AI, Jones CD, Dodson JA, Cene C, Bowles KH. Improving TRansitions ANd outcomeS for heart FailurE patients in home health CaRe (I-TRANSFER-HF): a type 1 hybrid effectiveness-implementation trial: study protocol. BMC Health Serv Res. 2024 Oct 1;24(1):1160. doi: 10.1186\u002Fs12913-024-11584-x.",[],{"nct_id":4,"conditions":136,"biomarkers":137},[19],[],{"nct_id":4,"found":15,"summary":139,"prompt_version":149},{"design":140,"status":141,"heading":142,"summary":143,"follow_up":144,"word_count":145,"commitments":146,"compensation":147,"drugs_mentioned":148},"This study plans to enroll 1094 participants. It uses a stepped-wedge randomized design, meaning different groups will start the I-TRANSFER-HF intervention at different times.","completed","I-TRANSFER-HF for Heart Failure Patients in Home Health Care","This study, called I-TRANSFER-HF, is for adults with heart failure who are transitioning from the hospital to home health care. It aims to improve this transition and prevent readmissions. The study tests a new approach called I-TRANSFER-HF, which includes early and frequent home health nurse visits and an outpatient doctor's visit within 7 days of leaving the hospital. Researchers want to see if I-TRANSFER-HF can reduce the number of times people return to the hospital within 30 days compared to usual care. They also want to understand what makes this new approach easy or difficult to put into practice. You may be eligible if you are an adult hospitalized for heart failure and are discharged to a participating home health agency.","Your hospital readmission status will be checked 30 days after your heart failure hospitalization.",121,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]