Transitional Care Model Evaluation 2020 (TCM2020)

Evaluation of the Multisite Replication of the Transitional Care Model

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumonia; COPD; CHF - Congestive Heart Failure
• Intervention / Treatment: Behavioral: Transitional care model (TCM); Behavioral: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 962
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Mathematica Policy Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Patient education about post-discharge self-care and medications, arrangement of needed social services, coordination of information from medical providers interacting with patient
Experimental: Control group; The control group receives usual discharge planning and post-discharge care.	Behavioral: Usual care; usual hospital discharge and post-discharge care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day readmission	whether readmitted to a hospital during the 30 days after initial discharge	30 days
emergency department visits	number of times treated in an emergency department after initial discharge	12 months
Mortality	whether died after initial discharge	12 months after initial discharge
Edmonton Symptom Assessment Scale	measures post-hospital symptoms, range 0-100, high score is bad	90 days after initial discharge
Patient-Reported Outcomes Measurement Information System Physical Functioning (SF10a)	functional status, range 10-50, high score is good	90 days after initial discharge
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)	index of depression and anxiety, range 0-12, high score is bad	90 days after initial discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skilled nursing facility days	Number of days spent in a skilled nursing facility	12 months after initial discharge
Home Health	number of home health visits	12 months after initial discharge
length of time to death or hospital admission	number of days between initial discharge and either death or readmission to hospital	12 months after initial discharge
hospice	whether admitted to hospice care	12 months after initial discharge

Collaborators and Investigators

• Sponsor: Mathematica Policy Research, Inc.
• Collaborators: University of Pennsylvania; University of California, San Francisco; Arnold Ventures; Veterans Health Administration--St. Louis and Cleveland; Trinity Health; Providence St. Joseph Health-Swedish Health Services (Swedish)
• Investigators: Study Director: Arkadipta Ghosh, PhD, Mathematica Policy Research, Inc.; Principal Investigator: Randall S Brown, PhD, Mathematica Policy Research, Inc.

Publications and helpful links

General Publications

• 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. Erratum In: J Am Geriatr Soc. 2004 Jul;52(7):1228.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: December 24, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: MathematicaPR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No