Transitional Care Model Evaluation 2020

NCT04212962 | Unknown

• 1 other identifier: MathematicaPR
• Study Type: interventional
• Target: 962
• Locations: 1 country
• Sites: 1

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.

Conditions

CHF - Congestive Heart Failure; COPD; Pneumonia

Outcome Measures

Primary Outcomes (2)

• Number of hospital admissions

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

  12 months

• Costs

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

  12 months

Secondary Outcomes (6)

• 30-day readmission

  30 days

• emergency department visits

  12 months

• Mortality

  12 months after initial discharge

• Edmonton Symptom Assessment Scale

  90 days after initial discharge

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

  90 days after initial discharge

Other Outcomes (4)

• Skilled nursing facility days

  12 months after initial discharge

• Home Health

  12 months after initial discharge

• length of time to death or hospital admission

  12 months after initial discharge

Study Arms (2)

Treatment group

EXPERIMENTAL

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)

Control group

EXPERIMENTAL

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

Behavioral: Usual care

Interventions

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

Treatment group

Usual care BEHAVIORAL

usual hospital discharge and post-discharge care

Control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mathematica Policy Research, Inc.: lead
• University of Pennsylvania: collaborator
• Arnold Ventures: collaborator
• Veterans Health Administration--St. Louis and Cleveland: collaborator
• Trinity Health System: collaborator
• Providence St. Joseph Health-Swedish Health Services (Swedish): collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Mathematica Policy Research

Princeton, New Jersey, 08540, United States

Location

Related Publications (5)

• 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.

  PMID: 21471497 BACKGROUND

• 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.

  PMID: 10029122 BACKGROUND

• 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.

  PMID: 15086645 BACKGROUND

• 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.

  PMID: 39582355 DERIVED

• 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.

  PMID: 36709563 DERIVED

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Pneumonia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections

Study Officials

• Arkadipta Ghosh, PhD

  Mathematica Policy Research, Inc.

  STUDY DIRECTOR

• Randall S Brown, PhD

  Mathematica Policy Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Advance practice registered nurses provide care management and education to intervention group patients prior to discharge and during the 90 days after transitioning to home.

Study Record Dates

• First Submitted: December 24, 2019
• First Posted: December 30, 2019
• Study Start: July 7, 2020
• Primary Completion: July 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)