Transitions of Care Clinic (TOCC)

NCT ID: NCT06937827

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-26
• Study Completion Date: 2026-12-15

Brief 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. 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.

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Active Cohort - Heart Failure (HF) Kit

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.

Group Type: EXPERIMENTAL

HF Kit and Follow-ups

Intervention Type: BEHAVIORAL

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

Historical controls

Standard of care education and follow up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HF Kit and Follow-ups

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Pregnant
• Diagnosed with dementia
• Without medical capacity or unable to provide own consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New Jersey Health Foundation

OTHER

Sponsor Role: collaborator

Hackensack Meridian Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandria Berns, PharmD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Locations

Ocean University Medical Center

Brick, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexandria Berns, PharmD

Role: CONTACT

Alexandria.Berns@hmhn.org

7328405100

Tina Wismar, MSN, FNP-BC

Role: CONTACT

Tina.Wismar@hmhn.org

7328405101

Facility Contacts

Alexandria Berns, PharmD

Role: primary

Alexandria.Berns@hmhn.org

732-840-5100

Other Identifiers

Pro2025-0058

Identifier Type: -

Identifier Source: org_study_id