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

962 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The study is a randomized controlled trial to estimate the effects of the transitional care model (TCM) on hospital admissions and patients' experience during the year following the patient's qualifying discharge. The University of Pennsylvania, where TCM was developed, will be the coordinating center for the implementation. The study will be conducted in three large health systems spread throughout the U.S., drawing patients from seven hospitals in those systems. Eligible patients are older adults (age 65 and older) admitted to a participating hospital with symptoms of heart failure (HF), chronic obstructive pulmonary disease (COPD), or pneumonia (PNA). The evaluation will be conducted by Mathematica.

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+