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Active, Not Recruiting

NCT Number: NCT04212962

Transitional Care Model Evaluation 2020

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transitional care model (TCM)

Behavioral

Patient education about post-discharge self-care and medications, arrangement of needed social services, coordination of information from medical providers interacting with patient

Usual Care

Behavioral

usual hospital discharge and post-discharge care

Primary outcomes

  1. Number of hospital admissions

    Time frame: 12 months

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

  2. Costs

    Time frame: 12 months

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

Secondary outcomes

  1. 30-day readmission

    Time frame: 30 days

    whether readmitted to a hospital during the 30 days after initial discharge

  2. emergency department visits

    Time frame: 12 months

    number of times treated in an emergency department after initial discharge

  3. length of time to death or hospital admission

    Time frame: 12 months after initial discharge

    number of days between initial discharge and either death or readmission to hospital

  4. Skilled nursing facility days

    Time frame: 12 months after initial discharge

    Number of days spent in a skilled nursing facility

  5. Mortality

    Time frame: 12 months after initial discharge

    whether died after initial discharge

  6. Edmonton Symptom Assessment Scale

    Time frame: 90 days after initial discharge

    measures post-hospital symptoms, range 0-100, high score is bad

  7. Patient-Reported Outcomes Measurement Information System Physical Functioning (SF10a)

    Time frame: 90 days after initial discharge

    functional status, range 10-50, high score is good

  8. Patient Health Questionnaire for Depression and Anxiety (PHQ-4)

    Time frame: 90 days after initial discharge

    index of depression and anxiety, range 0-12, high score is bad

Sponsors and collaborators

Lead sponsor

Mathematica Policy Research, Inc.

Other

Collaborators

  • Arnold Ventures
  • Providence St. Joseph Health-Swedish Health Services (Swedish)
  • Trinity Health System
  • University of California, San Francisco
  • University of Pennsylvania
  • Veterans Health Administration--St. Louis and Cleveland

Registry information

Official study title

Evaluation of the Multisite Replication of the Transitional Care Model

Acronym: TCM2020

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Dec 30, 2019
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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