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Transitional Care Model Evaluation 2020 (TCM2020)

Primary Purpose

CHF - Congestive Heart Failure, COPD, Pneumonia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transitional care model (TCM)
Usual care
Sponsored by
Mathematica Policy Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for CHF - Congestive Heart Failure

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mathematica Policy Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of hospital admissions
number of times admitted to the hospital during 12 months after initial discharge
Costs
Costs of medical care paid for by Medicare, Medicare Advantage plan, or Veterans Health Administration

Secondary Outcome Measures

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

Full Information

First Posted
December 24, 2019
Last Updated
March 14, 2023
Sponsor
Mathematica Policy Research, Inc.
Collaborators
University of Pennsylvania, Arnold Ventures, Veterans Health Administration--St. Louis and Cleveland, Trinity Health, Providence St. Joseph Health-Swedish Health Services (Swedish), University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04212962
Brief Title
Transitional Care Model Evaluation 2020
Acronym
TCM2020
Official Title
Evaluation of the Multisite Replication of the Transitional Care Model
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mathematica Policy Research, Inc.
Collaborators
University of Pennsylvania, Arnold Ventures, Veterans Health Administration--St. Louis and Cleveland, Trinity Health, Providence St. Joseph Health-Swedish Health Services (Swedish), University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CHF - Congestive Heart Failure, COPD, Pneumonia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
962 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
The treatment group receives the TCM intervention while in the hospital and during the first 90 days after returning to the community.
Arm Title
Control group
Arm Type
Experimental
Arm Description
The control group receives usual discharge planning and post-discharge care.
Intervention Type
Behavioral
Intervention Name(s)
Transitional care model (TCM)
Intervention Description
Patient education about post-discharge self-care and medications, arrangement of needed social services, coordination of information from medical providers interacting with patient
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
usual hospital discharge and post-discharge care
Primary Outcome Measure Information:
Title
Number of hospital admissions
Description
number of times admitted to the hospital during 12 months after initial discharge
Time Frame
12 months
Title
Costs
Description
Costs of medical care paid for by Medicare, Medicare Advantage plan, or Veterans Health Administration
Time Frame
12 months
Secondary Outcome Measure Information:
Title
30-day readmission
Description
whether readmitted to a hospital during the 30 days after initial discharge
Time Frame
30 days
Title
emergency department visits
Description
number of times treated in an emergency department after initial discharge
Time Frame
12 months
Title
Mortality
Description
whether died after initial discharge
Time Frame
12 months after initial discharge
Title
Edmonton Symptom Assessment Scale
Description
measures post-hospital symptoms, range 0-100, high score is bad
Time Frame
90 days after initial discharge
Title
Patient-Reported Outcomes Measurement Information System Physical Functioning (SF10a)
Description
functional status, range 10-50, high score is good
Time Frame
90 days after initial discharge
Title
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
Description
index of depression and anxiety, range 0-12, high score is bad
Time Frame
90 days after initial discharge
Other Pre-specified Outcome Measures:
Title
Skilled nursing facility days
Description
Number of days spent in a skilled nursing facility
Time Frame
12 months after initial discharge
Title
Home Health
Description
number of home health visits
Time Frame
12 months after initial discharge
Title
length of time to death or hospital admission
Description
number of days between initial discharge and either death or readmission to hospital
Time Frame
12 months after initial discharge
Title
hospice
Description
whether admitted to hospice care
Time Frame
12 months after initial discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arkadipta Ghosh, PhD
Organizational Affiliation
Mathematica Policy Research, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Randall S Brown, PhD
Organizational Affiliation
Mathematica Policy Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mathematica Policy Research
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21471497
Citation
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.
Results Reference
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PubMed Identifier
10029122
Citation
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.
Results Reference
background
PubMed Identifier
15086645
Citation
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.
Results Reference
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Transitional Care Model Evaluation 2020

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