Transitional Care Model Evaluation 2020

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Multisite Replication of the Transitional Care Model

Conditions
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CHF - Congestive Heart Failure, COPD, Pneumonia

Intervention / Treatment
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* Behavioral: Transitional care model (TCM)
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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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 |