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Transitional Care Model for Heart Failure (TCM2020 Trial)

N/A
Waitlist Available
Led By Randall S Brown, PhD
Research Sponsored by Mathematica Policy Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted from home with Pneumonia OR with a history of HF or COPD with symptoms of HF or COPD exacerbation or whose symptoms suggest a new HF or COPD diagnosis
Age 65 years and older
Must not have
Presence of active and untreated psychiatric conditions (ICD10: F10-F29)
Undergoing active cancer treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of the transitional care model on hospital admissions and patients' experience during the year following the patient's qualifying discharge.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial tests a care model rather than a drug, there are no direct side effects like those associated with medications. However, changes in care management could impact patient satisfaction and healthcare utilization.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was admitted from home with pneumonia or have a history of heart failure (HF) or chronic obstructive pulmonary disease (COPD) with worsening symptoms.
Select...
I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have untreated mental health conditions.
Select...
I am currently receiving treatment for cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Costs
Number of hospital admissions
Secondary study objectives
30-day readmission
Edmonton Symptom Assessment Scale
Mortality
+3 more
Other study objectives
Home Health
Skilled nursing facility days
hospice
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 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 groupExperimental Treatment1 Intervention
The control group receives usual discharge planning and post-discharge care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual care
2011
Completed Phase 4
~23770

Find a Location

Who is running the clinical trial?

Mathematica Policy Research, Inc.Lead Sponsor
66 Previous Clinical Trials
31,129,232 Total Patients Enrolled
University of PennsylvaniaOTHER
2,073 Previous Clinical Trials
42,713,294 Total Patients Enrolled
Arnold VenturesUNKNOWN
2 Previous Clinical Trials
1,132 Total Patients Enrolled

Media Library

Transitional care model (TCM) Clinical Trial Eligibility Overview. Trial Name: NCT04212962 — N/A
Congestive Heart Failure Research Study Groups: Treatment group, Control group
Congestive Heart Failure Clinical Trial 2023: Transitional care model (TCM) Highlights & Side Effects. Trial Name: NCT04212962 — N/A
Transitional care model (TCM) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04212962 — N/A
~180 spots leftby Nov 2025
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