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Active, not recruitingNCT04212962TCM2020Updated Jul 8, 2026

Transitional Care Model Evaluation 2020

An interventional study of Transitional care model (TCM) and Usual care in CHF - Congestive Heart Failure, COPD and Pneumonia, sponsored by Mathematica Policy Research, Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Mathematica Policy Research, Inc. · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
962
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • CHF - Congestive Heart Failure
  • COPD
  • Pneumonia
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
962 participants (actual)

Study arms

  • Experimental
    Treatment group

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

    Behavioral: Transitional care model (TCM)

  • Experimental
    Control group

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

    Behavioral: Usual care

Interventions

  • BehavioralTransitional care model (TCM)

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

  • BehavioralUsual care

    usual hospital discharge and post-discharge care

05

What researchers measure

Primary outcomes

  1. Number of hospital admissions

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

    Time frame: 12 months

  2. Costs

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

    Time frame: 12 months

Secondary outcomes

  1. 30-day readmission

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

    Time frame: 30 days

  2. emergency department visits

    number of times treated in an emergency department after initial discharge

    Time frame: 12 months

  3. length of time to death or hospital admission

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

    Time frame: 12 months after initial discharge

  4. Skilled nursing facility days

    Number of days spent in a skilled nursing facility

    Time frame: 12 months after initial discharge

  5. Mortality

    whether died after initial discharge

    Time frame: 12 months after initial discharge

  6. Edmonton Symptom Assessment Scale

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

    Time frame: 90 days after initial discharge

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

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

    Time frame: 90 days after initial discharge

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

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

    Time frame: 90 days after initial discharge

06

Study locations

1 site
  • Mathematica Policy Research
    Princeton, New Jersey 08540, United States
07

References and documents

Publications

  • Naylor MD, Aiken LH, Kurtzman ET, Olds DM, Hirschman KB. The care span: The importance of transitional care in achieving health reform. Health Aff (Millwood). 2011 Apr;30(4):746-54. doi: 10.1377/hlthaff.2011.0041. PubMed 21471497 ↗
  • Naylor MD, Brooten D, Campbell R, Jacobsen BS, Mezey MD, Pauly MV, Schwartz JS. Comprehensive discharge planning and home follow-up of hospitalized elders: a randomized clinical trial. JAMA. 1999 Feb 17;281(7):613-20. doi: 10.1001/jama.281.7.613. PubMed 10029122 ↗
  • Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc. 2004 May;52(5):675-84. doi: 10.1111/j.1532-5415.2004.52202.x. PubMed 15086645 ↗
  • McHugh M, Hirschman KB, Toles MP, Ahrens M, Morgan B, Osokpo O, Shaid EC, McCauley K, Hanlon AL, Pauly MV, Naylor MD. Implementing the MIRROR-TCM Randomised Control Trial During the COVID-19 Pandemic: A Mixed-Methods Evaluation. J Adv Nurs. 2025 Nov;81(11):7835-7854. doi: 10.1111/jan.16594. Epub 2024 Nov 25. PubMed 39582355 ↗
  • Naylor MD, Hirschman KB, Morgan B, McHugh M, Hanlon AL, Ahrens M, McCauley K, Shaid EC, Pauly MV. The study protocol to evaluate implementation of the transitional care model in four U.S. healthcare systems during the Covid-19 pandemic. Arch Gerontol Geriatr. 2023 May;108:104944. doi: 10.1016/j.archger.2023.104944. Epub 2023 Jan 25. PubMed 36709563 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04212962
Lead sponsor
Mathematica Policy Research, Inc.
Collaborators
University of Pennsylvania, Arnold Ventures, Veterans Health Administration--St. Louis and Cleveland, Trinity Health System, Providence St. Joseph Health-Swedish Health Services (Swedish), University of California, San Francisco
Responsible party
Randy Brown (Principal investigator, Mathematica Policy Research, Inc.) — Principal investigator
First posted
Dec 30, 2019
Start date
Jul 7, 2020
Primary completion
Jul 15, 2024
Completion
Dec 2026 (estimated)
Last update
Jul 8, 2026

Study contacts

Arkadipta Ghosh, PhD
study director · Mathematica Policy Research, Inc.
Randall S Brown, PhD
principal investigator · Mathematica Policy Research, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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