Clinical trial NCT04212962: Transitional Care Model Evaluation 2020
Official title: Evaluation of the Multisite Replication of the Transitional Care Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CHF - Congestive Heart Failure
COPD
Pneumonia
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Arnold Ventures
name: Veterans Health Administration--St. Louis and Cleveland
name: Trinity Health System
name: Providence St. Joseph Health-Swedish Health Services (Swedish)
name: University of California, San Francisco
First posted: 2019-12-30
Enrollment: 962
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of hospital admissions
timeFrame: 12 months
measure: Costs
timeFrame: 12 months
Secondary outcomes:
measure: 30-day readmission
timeFrame: 30 days
measure: emergency department visits
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months after initial discharge
measure: Edmonton Symptom Assessment Scale
timeFrame: 90 days after initial discharge
measure: Patient-Reported Outcomes Measurement Information System Physical Functioning (SF10a)
timeFrame: 90 days after initial discharge
measure: Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
timeFrame: 90 days after initial discharge
Other outcomes:
measure: Skilled nursing facility days
timeFrame: 12 months after initial discharge
measure: Home Health
timeFrame: 12 months after initial discharge
measure: length of time to death or hospital admission
timeFrame: 12 months after initial discharge
measure: hospice
timeFrame: 12 months after initial discharge
Locations:
city: Princeton
country: United States
facility: Mathematica Policy Research
state: New Jersey
Study officials:
affiliation: Mathematica Policy Research, Inc.
name: Arkadipta Ghosh, PhD
role: STUDY_DIRECTOR
affiliation: Mathematica Policy Research, Inc.
name: Randall S Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.