Transitional Care Model Evaluation 2020
- Conditions
- CHF - Congestive Heart FailurePneumoniaCOPD
- Registration Number
- NCT04212962
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 962
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of hospital admissions 12 months number of times admitted to the hospital during 12 months after initial discharge
Costs 12 months Costs of medical care paid for by Medicare, Medicare Advantage plan, or Veterans Health Administration
- Secondary Outcome Measures
Name Time Method 30-day readmission 30 days whether readmitted to a hospital during the 30 days after initial discharge
Patient-Reported Outcomes Measurement Information System Physical Functioning (SF10a) 90 days after initial discharge functional status, range 10-50, high score is good
Mortality 12 months after initial discharge whether died after initial discharge
Edmonton Symptom Assessment Scale 90 days after initial discharge measures post-hospital symptoms, range 0-100, high score is bad
Patient Health Questionnaire for Depression and Anxiety (PHQ-4) 90 days after initial discharge index of depression and anxiety, range 0-12, high score is bad
emergency department visits 12 months number of times treated in an emergency department after initial discharge
Trial Locations
- Locations (1)
Mathematica Policy Research
🇺🇸Princeton, New Jersey, United States
Mathematica Policy Research🇺🇸Princeton, New Jersey, United States