Heart FailureNCT06118983
Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF)
A study testing I-TRANSFER-HF in people with Heart Failure, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- I-TRANSFER-HF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,094 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jul 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Aim 1, Inclusion Criteria:
- Adults hospitalized for HF who transition from participating hospitals to their partner HHC agency during the study period.
Aim 1, Exclusion Criteria:
- 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 2, Inclusion Criteria:
- 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.
Aim 2, Exclusion Criteria:
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
VNS Health Partners in Care
New York, New York, 10017
Kathy Bowles, PhD, RN,FAAN, bowles@nursing.upenn.edu
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Madeline R Sterling, MD, MPH, MS, 646-962-5029, mrs9012@med.cornell.edu
Madeline R Sterling, MD, MPH, MS
About this study
Official title: Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF): A Type 1 Hybrid Effectiveness- Implementation Trial
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.
The study is interested in two questions:
Read more
- Is I-TRANSFER-HF better than usual care at preventing heart failure patients from returning to the hospital within 30 days?
- Are there parts of I-TRANSFER-HF that are easy or hard to implement in the real world?
The 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.
Read the detailed description
The investigators' will test two hypotheses:
Hypothesis 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.
Hypothesis 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).
- Conditions
- Heart Failure
- Being tested
- I-TRANSFER-HF
- Keywords
- home health care, hospital-to-home transition
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-TRANSFER-HFOther
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.
| Study group | Role | What they receive |
|---|---|---|
| I-TRANSFER-HF | Experimental | This is a 1-year long intervention period when I-TRANSFER-HF is in operation. Receives: Other: I-TRANSFER-HF |
| Standard of Care (usual care) | No intervention | This is a baseline period of usual care (UC) with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days following post-Index HF Hospitalization
Number of Eligible patients
Number of heart failure patients eligible to receive I-TRANSFER-HF as assessed by Medicare claims data
Measured: 12 months
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
Measured: 12 months
Modality of outpatient follow-up
The modality of outpatient follow-up received (in-person vs. virtual visit) as assessed by Medicare claims data
Measured: 12 months
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
Measured: 12 months
Timeliness of Post-Hospital Outpatient Follow-Up
The timeliness of outpatient visits within 7 days of hospital discharge as assessed by Medicare claims data
Measured: 12 months
Feasibility of implementing I-TRANSFER-HF (Qualitative Interviews)
Feasibility will be assessed through qualitative interviews with site stakeholders
Measured: 30 days after intervention (year of intervention)
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.
Measured: 30 days after intervention (year of intervention)
Secondary outcomes (7)
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
Measured: 30 days following post-Index heart failure Hospitalization.
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.
Measured: During a 12-month period (year of intervention)
Acceptability of I-TRANSFER-HF - Qualitative Interviews
Acceptability will be assessed through qualitative interviews.
Measured: 30 days after intervention (year of intervention)
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.
Measured: 30 days after intervention (year of intervention)
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.
Measured: 30 days after intervention (year of intervention)
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.
Measured: 30 days after intervention (year of intervention)
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.
Measured: 30 days after intervention (year of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start28 Jul 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,094 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Johns Hopkins University, University of Colorado, Denver, NYU Langone Health, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Madeline R Sterling, MD, MPH, MS, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118983
- Sponsor's protocol ID
- 23-06026204
- Other IDs
- R01HL169312
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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/s12913-024-11584-x.
PubMed 39354472
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF): A Type 1 Hybrid Effectiveness- Implementation Trial
- ClinicalTrials.gov ID
- NCT06118983
- Acronym / sponsor ID
- 23-06026204
- Conditions
- Heart Failure
- Keywords
- home health care, hospital-to-home transition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,094 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Johns Hopkins University, University of Colorado, Denver, NYU Langone Health, University of California, San Diego
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The study is interested in two questions:
- Is I-TRANSFER-HF better than usual care at preventing heart failure patients from returning to the hospital within 30 days?
- Are there parts of I-TRANSFER-HF that are easy or hard to implement in the real world?
The 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.
Detailed description
The investigators' will test two hypotheses:
Hypothesis 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.
Hypothesis 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-TRANSFER-HF | Experimental | Other: I-TRANSFER-HFThis is a 1-year long intervention period when I-TRANSFER-HF is in operation. |
| Standard of Care (usual care) | No intervention | –This is a baseline period of usual care (UC) with no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-TRANSFER-HFI-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. | Other | I-TRANSFER-HF |
Primary outcome
All-cause 30-day hospital readmission
Time frame: 30 days following post-Index HF Hospitalization
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
Number of Eligible patients
Time frame: 12 months
Number of heart failure patients eligible to receive I-TRANSFER-HF as assessed by Medicare claims data
Number of Eligible Patients Who Received Protocol Components
Time frame: 12 months
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
Modality of outpatient follow-up
Time frame: 12 months
The modality of outpatient follow-up received (in-person vs. virtual visit) as assessed by Medicare claims data
Timeliness of Post-Hospital Discharge Home Health Nursing Evaluation
Time frame: 12 months
The timeliness of first-week nursing visits within 2 days of hospital discharge as assessed by Medicare claims data
Timeliness of Post-Hospital Outpatient Follow-Up
Time frame: 12 months
The timeliness of outpatient visits within 7 days of hospital discharge as assessed by Medicare claims data
Feasibility of implementing I-TRANSFER-HF (Qualitative Interviews)
Time frame: 30 days after intervention (year of intervention)
Feasibility will be assessed through qualitative interviews with site stakeholders
Feasibility of implementing I-TRANSFER-HF (Surveys)
Time frame: 30 days after intervention (year of intervention)
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.
7 secondary outcomes
All-cause 30-day ED visits
Time frame: 30 days following post-Index heart failure Hospitalization.
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
Time frame: During a 12-month period (year of intervention)
Acceptability of I-TRANSFER-HF - Qualitative Interviews
Time frame: 30 days after intervention (year of intervention)
Acceptability of Intervention Measure for the I-TRANSFER-HF Study - Survey
Time frame: 30 days after intervention (year of intervention)
Fidelity of I-TRANSFER-HF (Participant-Completed)
Time frame: 30 days after intervention (year of intervention)
Fidelity of I-TRANSFER-HF (Observational Ratings)
Time frame: 30 days after intervention (year of intervention)
Adaptation of I-TRANSFER-HF
Time frame: 30 days after intervention (year of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 39354472Sterling 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/s12913-024-11584-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Madeline R Sterling, MD, MPH, MS principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-TRANSFER-HF in people with Heart Failure, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeline R Sterling, MD, MPH, MS (6469625029, mrs9012@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause 30-day hospital readmission (time frame: 30 days following post-Index HF Hospitalization). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.