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Trial record 1 of 2 for:    mathematica | heart failure
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Transitional Care Model Evaluation 2020 (TCM2020)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04212962
Recruitment Status : Active, not recruiting
First Posted : December 30, 2019
Last Update Posted : March 16, 2023
Sponsor:
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
Information provided by (Responsible Party):
Randy Brown, Mathematica Policy Research, Inc.

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.

Condition or disease Intervention/treatment Phase
CHF - Congestive Heart Failure COPD Pneumonia Behavioral: Transitional care model (TCM) Behavioral: Usual care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 962 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Evaluation of the Multisite Replication of the Transitional Care Model
Actual Study Start Date : July 7, 2020
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : February 2025

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




Primary Outcome Measures :
  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 Outcome Measures :
  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. Mortality [ Time Frame: 12 months after initial discharge ]
    whether died after initial discharge

  4. Edmonton Symptom Assessment Scale [ Time Frame: 90 days after initial discharge ]
    measures post-hospital symptoms, range 0-100, high score is bad

  5. 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

  6. 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


Other Outcome Measures:
  1. Skilled nursing facility days [ Time Frame: 12 months after initial discharge ]
    Number of days spent in a skilled nursing facility

  2. Home Health [ Time Frame: 12 months after initial discharge ]
    number of home health visits

  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. hospice [ Time Frame: 12 months after initial discharge ]
    whether admitted to hospice care



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04212962


Locations
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United States, New Jersey
Mathematica Policy Research
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Mathematica Policy Research, Inc.
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
Investigators
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Study Director: Arkadipta Ghosh, PhD Mathematica Policy Research, Inc.
Principal Investigator: Randall S Brown, PhD Mathematica Policy Research, Inc.
Publications:
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Responsible Party: Randy Brown, Principal investigator, Mathematica Policy Research, Inc.
ClinicalTrials.gov Identifier: NCT04212962    
Other Study ID Numbers: MathematicaPR
First Posted: December 30, 2019    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases