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Clinical Trials/NCT04212962
NCT04212962
Active, Not Recruiting
N/A

Evaluation of the Multisite Replication of the Transitional Care Model

Mathematica Policy Research, Inc.1 site in 1 country962 target enrollmentJuly 7, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
CHF - Congestive Heart Failure
Sponsor
Mathematica Policy Research, Inc.
Enrollment
962
Locations
1
Primary Endpoint
Number of hospital admissions
Status
Active, Not Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

The Transitional Care Model (TCM) is an advanced practice registered nurse (APRN) led, team-based, care management strategy designed to improve the care and outcomes of high-risk older adults transitioning from hospital to home. Eligible patients who agree to participate in the study will be randomly assigned to either the intervention group, which receives the TCM intervention, or the control group, which receives usual care (standard hospital discharge planning and post-hospital follow up services). The target sample size for the study is close to 1000, evenly divided into intervention and control groups, with 250 to 270 patients derived from each of UCSF and Trinity health systems, and another 450 recruited from the two VHA hospitals combined. Data will be collected at intake, prior to randomization, by enrollment coordinators at each of the participating hospitals. Followup data will be collected in a survey of patients conducted 90 days after discharge, and from claims data obtained from Medicare, Medicare Advantage plans, and the VHA.

Registry
clinicaltrials.gov
Start Date
July 7, 2020
End Date
February 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Randy Brown

Principal investigator

Mathematica Policy Research, Inc.

Eligibility Criteria

Inclusion Criteria

  • Age 65 years and older
  • 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
  • English and non-English speaking, able to respond to questions
  • Reachable by telephone after discharge
  • Resides within the geographic service area
  • Consent to participation

Exclusion Criteria

  • Enrolled in Medicare's Hospice or End-Stage Renal Disease programs
  • Presence of active and untreated psychiatric conditions (ICD10: F10-F29)
  • Long-term care resident
  • Undergoing active cancer treatment
  • Currently enrolled in another RCT

Outcomes

Primary Outcomes

Number of hospital admissions

Time Frame: 12 months

number of times admitted to the hospital during 12 months after initial discharge

Costs

Time Frame: 12 months

Costs of medical care paid for by Medicare, Medicare Advantage plan, or Veterans Health Administration

Secondary Outcomes

  • 30-day readmission(30 days)
  • Patient-Reported Outcomes Measurement Information System Physical Functioning (SF10a)(90 days after initial discharge)
  • Patient Health Questionnaire for Depression and Anxiety (PHQ-4)(90 days after initial discharge)
  • emergency department visits(12 months)
  • Mortality(12 months after initial discharge)
  • Edmonton Symptom Assessment Scale(90 days after initial discharge)

Study Sites (1)

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