Transitional Care Model for Heart Failure

(TCM2020 Trial)

Overseen By Randall S Brown, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Mathematica Policy Research, Inc.

Disqualifiers: Hospice, End-stage renal, Psychiatric, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 90

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how the Transitional Care Model (TCM) can reduce hospital visits and improve the overall experience for patients with specific health conditions. It focuses on individuals admitted to the hospital with symptoms of heart failure, chronic obstructive pulmonary disease (COPD), or pneumonia. Participants will either receive TCM support during their hospital stay and for 90 days after returning home, or they will receive usual care. Individuals aged 65 or older, hospitalized with symptoms of these conditions and reachable by phone after discharge, might be suitable for this trial. The study will occur in various hospitals across the U.S. and will assess the effectiveness of this care approach. As an unphased trial, it offers a unique opportunity to contribute to understanding how TCM can enhance patient care and reduce hospital visits.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the transitional care model is safe for older adults with heart failure, COPD, or pneumonia?

Research has shown that the Transitional Care Model (TCM) is generally safe for patients. Studies have found that this approach helps patients manage their health more effectively after hospital discharge. One study found that fewer patients needed to return to the hospital when using TCM. Another study noted that TCM led to lower healthcare costs and fewer emergency visits. This suggests that the model not only supports better health outcomes but also appears to be well-tolerated by patients. The studies reviewed have reported no major safety concerns. While consulting a doctor is always advisable, the available data provide a positive view of TCM's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Transitional Care Model (TCM) for heart failure because it offers a unique approach to managing patients' recovery after hospital discharge. Unlike standard care, which typically involves routine discharge planning and follow-up, TCM provides a more comprehensive and personalized plan that starts in the hospital and continues for the first 90 days after patients return home. This model emphasizes patient education, self-management, and close monitoring, which could reduce hospital readmissions and improve overall patient outcomes. By focusing on a seamless transition from hospital to home, TCM aims to address gaps in care that are often present in traditional treatment pathways.

What evidence suggests that the transitional care model is effective for heart failure?

Research has shown that the Transitional Care Model (TCM), which participants in this trial may receive, can benefit patients with heart failure. Studies find that TCM reduces hospital readmissions and emergency room visits. It also helps patients manage their care more effectively, especially immediately after hospital discharge. Some research notes that while TCM lowers readmissions, it does not significantly impact overall death rates. Overall, TCM aims to improve care and outcomes for older adults with long-term illnesses. Meanwhile, the control group in this trial will receive standard discharge planning and post-discharge care. ^{1 6 7 8 9}

Who Is on the Research Team?

Arkadipta Ghosh, PhD

Principal Investigator

Mathematica Policy Research, Inc.

Randall S Brown, PhD

Principal Investigator

Mathematica Policy Research, Inc.

Are You a Good Fit for This Trial?

This trial is for adults aged 65 and older who have been hospitalized with heart failure, COPD, or pneumonia. Participants must live in the service area, be reachable by phone after discharge, and able to answer questions. They can't be in long-term care or other trials, enrolled in certain Medicare programs, have untreated psychiatric conditions or be undergoing cancer treatment.

Inclusion Criteria

I can be reached by phone after leaving the hospital.

I was admitted from home with pneumonia or have a history of heart failure (HF) or chronic obstructive pulmonary disease (COPD) with worsening symptoms.

Consent to participation

Exclusion Criteria

I do not have untreated mental health conditions.

Currently enrolled in another RCT

You are currently in a hospice or end-stage renal disease program through Medicare.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TCM intervention while in the hospital and during the first 90 days after returning to the community

12 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment through surveys and claims data

12 months

Survey at 90 days post-discharge

Long-term monitoring

Participants' hospital admissions, emergency visits, and other health outcomes are tracked for 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Transitional care model (TCM)
• Usual care

Trial Overview The study compares a Transitional Care Model (TCM) against usual care to see if TCM reduces hospital readmissions and improves patient experience post-discharge. It's a randomized controlled trial conducted across three U.S. health systems involving seven hospitals.

How Is the Trial Designed?

Group I: Treatment group Experimental Treatment 1 Intervention

The treatment group receives the TCM intervention while in the hospital and during the first 90 days after returning to the community.

Group II: Control group Experimental Treatment 1 Intervention

The control group receives usual discharge planning and post-discharge care.

Who Is Running the Clinical Trial?

Mathematica Policy Research, Inc.

Lead Sponsor

Trials

68

Recruited

31,130,000+

Trinity Health System

Industry Sponsor

Trials

4

Recruited

1,500+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Arnold Ventures

Collaborator

Trials

3

Recruited

2,100+

Veterans Health Administration--St. Louis and Cleveland

Collaborator

Trials

1

Recruited

960+

Trinity Health

Collaborator

Trials

2

Recruited

1,400+

Providence St. Joseph Health-Swedish Health Services (Swedish)

Collaborator

Trials

1

Recruited

960+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9621739/

Effectiveness of Transitional Care Interventions for Heart ... It was found that implementing TCIs resulted in a reduction of all-cause re-admission and all-cause mortality.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666142X23000358

The effects on rehospitalization rate of transitional care ... The intervention group had multiple illnesses; only 4 patients were readmitted for heart failure, and the readmission rate due to worsening heart failure was ...

3. jtd.amegroups.org jtd.amegroups.org/article/view/62876/html

A systematic review and meta-analysis of the effect of ... Transitional care interventions can reduce the rate of patient readmission and emergency visits but have no significant impact on the mortality of patients.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10563773/

Transitional Care in Patients with Heart Failure: A Concept ... This study found that transitional care in heart failure patients is a systemic care process during a vulnerable period that improves patient self-management ...

5. ojin.nursingworld.org ojin.nursingworld.org/table-of-contents/volume-20-2015/number-3-september-2015/continuity-of-care-transitional-care-model/

Continuity of Care: The Transitional Care Model | OJIN The TCM intervention focuses on improving care; enhancing patient and family caregiver outcomes; and reducing costs among vulnerable, chronically ill, older ...

6. bmcnurs.biomedcentral.com bmcnurs.biomedcentral.com/articles/10.1186/s12912-025-03447-5

Implementation and evaluation of hospital-to-home ... This study aims to investigate the impact and evaluate the effectiveness of hospital-to-home transitional care for patients with chronic heart failure (CHF).

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ejhf.3134

3‐year outcomes of the Patient‐Centered Care Transitions ... We tested the effect of a transitional care model that included month-long nurse-led home visits and long-term heart function clinic visits.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12161123/

Care Transition Management and Patient Outcomes in ... Billing for TCM was associated with significantly lower spending, emergency department visits, hospitalizations, readmissions, and mortality in ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2773492

Evaluation of a Transitional Care Program After ... A meta-analysis of 53 trials of transitional care services with more than 12 000 patients with heart failure published from 2000 to 2015 found ...