Transitional Care Model Evaluation 2020

COPD Clinical Trial

— TCM2020  

Official title:

Evaluation of the Multisite Replication of the Transitional Care Model

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04212962
• Other study ID #: MathematicaPR
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: February 2025

Study information

• Verified date: March 2023
• Source: Mathematica Policy Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 962
• Est. completion date: February 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CHF - Congestive Heart Failure
• COPD
• Heart Failure
• Pneumonia

Intervention

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
• Usual care
usual hospital discharge and post-discharge care

Locations

Country	Name	City	State
United States	Mathematica Policy Research	Princeton	New Jersey

Sponsors (7)

Lead Sponsor	Collaborator
Mathematica Policy Research, Inc.	Arnold Ventures, Providence St. Joseph Health-Swedish Health Services (Swedish), Trinity Health, University of California, San Francisco, University of Pennsylvania, Veterans Health Administration--St. Louis and Cleveland

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skilled nursing facility days	Number of days spent in a skilled nursing facility	12 months after initial discharge
Other	Home Health	number of home health visits	12 months after initial discharge
Other	length of time to death or hospital admission	number of days between initial discharge and either death or readmission to hospital	12 months after initial discharge
Other	hospice	whether admitted to hospice care	12 months after initial discharge
Primary	Number of hospital admissions	number of times admitted to the hospital during 12 months after initial discharge	12 months
Primary	Costs	Costs of medical care paid for by Medicare, Medicare Advantage plan, or Veterans Health Administration	12 months
Secondary	30-day readmission	whether readmitted to a hospital during the 30 days after initial discharge	30 days
Secondary	emergency department visits	number of times treated in an emergency department after initial discharge	12 months
Secondary	Mortality	whether died after initial discharge	12 months after initial discharge
Secondary	Edmonton Symptom Assessment Scale	measures post-hospital symptoms, range 0-100, high score is bad	90 days after initial discharge
Secondary	Patient-Reported Outcomes Measurement Information System Physical Functioning (SF10a)	functional status, range 10-50, high score is good	90 days after initial discharge
Secondary	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