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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| Arnold Ventures | OTHER |
| Veterans Health Administration--St. Louis and Cleveland | UNKNOWN |
| Trinity Health System |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | The treatment group receives the TCM intervention while in the hospital and during the first 90 days after returning to the community. |
|
| Control group | Experimental | The control group receives usual discharge planning and post-discharge care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transitional care model (TCM) | Behavioral | Patient education about post-discharge self-care and medications, arrangement of needed social services, coordination of information from medical providers interacting with patient |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arkadipta Ghosh, PhD | Mathematica Policy Research, Inc. | Study Director |
| Randall S Brown, PhD | Mathematica Policy Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mathematica Policy Research | Princeton | New Jersey | 08540 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21471497 | Background | 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. | |
| 10029122 | Background | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| INDUSTRY |
| Providence St. Joseph Health-Swedish Health Services (Swedish) | UNKNOWN |
| University of California, San Francisco | OTHER |
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.
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| Usual care | Behavioral | usual hospital discharge and post-discharge care |
|
| 12 months |
| 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 |
| Skilled nursing facility days | Number of days spent in a skilled nursing facility | 12 months after initial discharge |
| 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 |
| 15086645 | Background | 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. |
| 39582355 | Derived | McHugh M, Hirschman KB, Toles MP, Ahrens M, Morgan B, Osokpo O, Shaid EC, McCauley K, Hanlon AL, Pauly MV, Naylor MD. Implementing the MIRROR-TCM Randomised Control Trial During the COVID-19 Pandemic: A Mixed-Methods Evaluation. J Adv Nurs. 2025 Nov;81(11):7835-7854. doi: 10.1111/jan.16594. Epub 2024 Nov 25. |
| 36709563 | Derived | Naylor MD, Hirschman KB, Morgan B, McHugh M, Hanlon AL, Ahrens M, McCauley K, Shaid EC, Pauly MV. The study protocol to evaluate implementation of the transitional care model in four U.S. healthcare systems during the Covid-19 pandemic. Arch Gerontol Geriatr. 2023 May;108:104944. doi: 10.1016/j.archger.2023.104944. Epub 2023 Jan 25. |
| D012140 |
| Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |