Heart Failure With Preserved Ejection FractionNCT06937827
Transitions of Care Clinic (TOCC)
A study testing HF Kit and Follow-ups in people with Heart Failure With Preserved Ejection Fraction, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
The transition period from hospital to home is a time of heightened risk for patients to experience adverse events, medication errors, and readmission to the hospital. Patients at the highest risk include older adults and patients with low health literacy, socioeconomic disadvantages, and/or multiple comorbidities. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- HF Kit and Follow-ups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2025to 7 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ages 18 to 90 years old discharged from Ocean University Medical Center (OUMC)
- Inpatient admission for heart failure with preserved ejection fraction (HFpEF) exacerbation
- Patient discharged home with or without homecare
Who cannot join
- Refuse to participate in TOCC phone calls
- Discharged to a facility
- Discharged with homecare services
- Discharged on hospice services
- Hemodialysis
- Leave against medical advice (AMA)
Show all 9Show fewer
- Pregnant
- Diagnosed with dementia
- Without medical capacity or unable to provide own consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Ocean University Medical Center
Brick, New Jersey, 08724
About this study
Official title: Impact of Multidisciplinary Transitions of Care Clinic on Readmission Rates for Patients With Heart Failure With Preserved Ejection Fraction at a University Medical Center
The transition period from hospital to home is a time of heightened risk for patients to experience adverse events, medication errors, and readmission to the hospital. Patients at the highest risk include older adults and patients with low health literacy, socioeconomic disadvantages, and/or multiple comorbidities. This project proposes to expand the existing Transitions of Care Clinic (TOCC) which was recently introduced in our institution in 2024, to bridge the gap in care between hospital discharge to home and connect discharged patients to their outpatient providers with a focus on patients with heart failure (HF).
The existing TOCC, a multidisciplinary team composed of a pharmacist and a nurse practitioner, seeks to improve the services that are currently being provided to patients and enhance the transitions of care process by providing patients with education, tools, and resources to help manage their chronic disease. With this study, we propose to expand TOCC by offering extensive education to patients via iPad videos and providing them with HF tool kits prior to their discharge. We will also assist with scheduling follow appointments with their outpatient providers and follow up with patients after the appointment takes place to re-evaluate their needs and reinforce self management of heart failure.
By targeting patients being treated for acute exacerbation of heart failure with preserved ejection fraction (HFpEF), this study aims to facilitate the transition of care, reduce hospital readmissions and improve patients' quality of life and satisfaction. Patients with HFpEF represent a majority of the HF patients that are readmitted at OUMC. HFpEF patients have fewer guideline recommended treatments and represent a vulnerable patient population. The HF tool kits will provide these patients with the essential tools, resources, and log sheets for self-management such as monitoring daily weights, monitoring blood pressure and heart rate. Patients provided with a kit will receive an initial phone call from TOCC within 1 to 3 days of discharge and a second phone call within 21-24-days post discharge.
- Being tested
- HF Kit and Follow-ups
- Keywords
- Discharge plans, heart failure with preserved ejection fraction, Readmissions, transition of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF Kit and Follow-upsBehavioural
These patients will receive TOCC intervention, which includes: pre-discharge introduction to the program; watching educational videos about heart failure via Mytonomy; receiving the American Heart Association's "Get With The Guidelines" (GWTG) booklet and a heart failure (HF) kit. These patients will receive a follow-up phone call days 1 to 3 days post discharge from the pharmacist and nurse practitioner to review discharge instructions, provide medication education, and assess clinical status; a second follow-up call will be conducted days 21 to 24 post discharge. The HF tool kits will provide these patients with the essential tools, resources, and log sheets for self-management such as monitoring daily weights, monitoring blood pressure and heart rate
| Study group | Role | What they receive |
|---|---|---|
| Active Cohort - Heart Failure (HF) Kit | Experimental | Extensive education to patients via iPad videos and providing them with HF kits prior to their discharge. Structured follow up post discharge and linkage to care. Receives: Behavioral: HF Kit and Follow-ups |
| Historical controls | No intervention | Standard of care education and follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause 30-day hospital readmission rate for heart failure
This measures the percentage of patients initially hospitalized for HF who are readmitted to the hospital for any reason within 30 days of discharge. This is a standard metric for evaluating HF care and aligns directly with the objective of reducing readmissions.
Measured: 30 days post discharge
Secondary outcomes (2)
7-Day Provider Follow-Up
Proportion of patients in each cohort (intervention and control) who receive a follow-up contact from an outpatient provider within 7 days of discharge.
Measured: 7 day post discharge
Patient Satisfaction with Transition of Care
Patient-reported satisfaction with the transition of care process, measured using a post discharge survey.
Patient-reported satisfaction will be measured using a 5-item survey on patients' perception regarding the different components of the project (kit, education, phone calls and medication information). Four questions are using Likert scale 1-5 with 1 being "not helpful/satisfied" and 5 being very satisfied. The last question captures overall satisfaction with a Yes/No question.
Measured: 31 to 45 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start26 Jun 2025
- Primary completion7 Sep 2026
- Study completion7 Sep 2026
Why it stopped: Funding restrains
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Active cohort will be compared to historical controls
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Health Foundation
- Responsible party
- Sponsor
- Investigators
- Alexandria Berns, PharmD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937827
- Sponsor's protocol ID
- Pro2025-0058
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Multidisciplinary Transitions of Care Clinic on Readmission Rates for Patients With Heart Failure With Preserved Ejection Fraction at a University Medical Center
- ClinicalTrials.gov ID
- NCT06937827
- Acronym / sponsor ID
- Pro2025-0058
- Keywords
- Discharge plans, heart failure with preserved ejection fraction, Readmissions, transition of care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding restrains
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- New Jersey Health Foundation
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 7 Sep 2026 (actual)
- Study completion
- 7 Sep 2026 (actual)
- First posted
- 22 Apr 2025 (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.
The transition period from hospital to home is a time of heightened risk for patients to experience adverse events, medication errors, and readmission to the hospital. Patients at the highest risk include older adults and patients with low health literacy, socioeconomic disadvantages, and/or multiple comorbidities. This project proposes to expand the existing Transitions of Care Clinic (TOCC) which was recently introduced in our institution in 2024, to bridge the gap in care between hospital discharge to home and connect discharged patients to their outpatient providers with a focus on patients with heart failure (HF).
The existing TOCC, a multidisciplinary team composed of a pharmacist and a nurse practitioner, seeks to improve the services that are currently being provided to patients and enhance the transitions of care process by providing patients with education, tools, and resources to help manage their chronic disease. With this study, we propose to expand TOCC by offering extensive education to patients via iPad videos and providing them with HF tool kits prior to their discharge. We will also assist with scheduling follow appointments with their outpatient providers and follow up with patients after the appointment takes place to re-evaluate their needs and reinforce self management of heart failure.
By targeting patients being treated for acute exacerbation of heart failure with preserved ejection fraction (HFpEF), this study aims to facilitate the transition of care, reduce hospital readmissions and improve patients' quality of life and satisfaction. Patients with HFpEF represent a majority of the HF patients that are readmitted at OUMC. HFpEF patients have fewer guideline recommended treatments and represent a vulnerable patient population. The HF tool kits will provide these patients with the essential tools, resources, and log sheets for self-management such as monitoring daily weights, monitoring blood pressure and heart rate. Patients provided with a kit will receive an initial phone call from TOCC within 1 to 3 days of discharge and a second phone call within 21-24-days post discharge.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Active cohort will be compared to historical controls
| Arm | Type | Receives |
|---|---|---|
| Active Cohort - Heart Failure (HF) Kit | Experimental | Behavioral: HF Kit and Follow-upsExtensive education to patients via iPad videos and providing them with HF kits prior to their discharge. Structured follow up post discharge and linkage to care. |
| Historical controls | No intervention | –Standard of care education and follow up |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ages 18 to 90 years old discharged from Ocean University Medical Center (OUMC)
- Inpatient admission for heart failure with preserved ejection fraction (HFpEF) exacerbation
- Patient discharged home with or without homecare
Key exclusion criteria (9 listed)
- Refuse to participate in TOCC phone calls
- Discharged to a facility
- Discharged with homecare services
- Discharged on hospice services
- Hemodialysis
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 |
|---|---|---|
| HF Kit and Follow-upsThese patients will receive TOCC intervention, which includes: pre-discharge introduction to the program; watching educational videos about heart failure via Mytonomy; receiving the American Heart Association's "Get With The Guidelines" (GWTG) booklet and a heart failure (HF) kit. These patients will receive a follow-up phone call days 1 to 3 days post discharge from the pharmacist and nurse practitioner to review discharge instructions, provide medication education, and assess clinical status; a second follow-up call will be conducted days 21 to 24 post discharge. The HF tool kits will provide these patients with the essential tools, resources, and log sheets for self-management such as monitoring daily weights, monitoring blood pressure and heart rate | Behavioural | Active Cohort - Heart Failure (HF) Kit |
Primary outcome
All-cause 30-day hospital readmission rate for heart failure
Time frame: 30 days post discharge
This measures the percentage of patients initially hospitalized for HF who are readmitted to the hospital for any reason within 30 days of discharge. This is a standard metric for evaluating HF care and aligns directly with the objective of reducing readmissions.
2 secondary outcomes
7-Day Provider Follow-Up
Time frame: 7 day post discharge
Patient Satisfaction with Transition of Care
Time frame: 31 to 45 days post discharge
Results and safety
The study was stopped early (reason given: Funding restrains). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- 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. This study is not recruiting at the moment.
Alexandria Berns, PharmD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HF Kit and Follow-ups in people with Heart Failure With Preserved Ejection Fraction, run by Hackensack Meridian Health at 1 site 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?
The sponsor lists 3 inclusion and 9 exclusion criteria. 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: stopped early, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Funding restrains). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause 30-day hospital readmission rate for heart failure (time frame: 30 days post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2026.