CHF - Congestive Heart FailureTCM2020NCT04212962
Transitional Care Model Evaluation 2020
A study testing Transitional care model (TCM) in people with CHF - Congestive Heart Failure and COPD, run by Mathematica Policy Research, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- CHF - Congestive Heart Failure, COPD, Pneumonia
- What is being tested?
- Transitional care model (TCM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 962 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mathematica Policy Research
Princeton, New Jersey, 08540
About this study
Official title: Evaluation of the Multisite Replication of the Transitional Care Model
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.
Read the 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.
- Conditions
- CHF - Congestive Heart Failure, COPD, Pneumonia
- Being tested
- Transitional care model (TCM), Usual care
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional care model (TCM)Behavioural
Patient education about post-discharge self-care and medications, arrangement of needed social services, coordination of information from medical providers interacting with patient
Usual careBehavioural
usual hospital discharge and post-discharge care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Transitional care model (TCM) |
| Control group | Experimental | The control group receives usual discharge planning and post-discharge care. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospital admissions
number of times admitted to the hospital during 12 months after initial discharge
Measured: 12 months
Costs
Costs of medical care paid for by Medicare, Medicare Advantage plan, or Veterans Health Administration
Measured: 12 months
Secondary outcomes (8)
30-day readmission
whether readmitted to a hospital during the 30 days after initial discharge
Measured: 30 days
emergency department visits
number of times treated in an emergency department after initial discharge
Measured: 12 months
length of time to death or hospital admission
number of days between initial discharge and either death or readmission to hospital
Measured: 12 months after initial discharge
Skilled nursing facility days
Number of days spent in a skilled nursing facility
Measured: 12 months after initial discharge
Mortality
whether died after initial discharge
Measured: 12 months after initial discharge
Edmonton Symptom Assessment Scale
measures post-hospital symptoms, range 0-100, high score is bad
Measured: 90 days after initial discharge
Patient-Reported Outcomes Measurement Information System Physical Functioning (SF10a)
functional status, range 10-50, high score is good
Measured: 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
Measured: 90 days after initial discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start7 Jul 2020
- Primary completion15 Jul 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CHF - Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 962 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Arnold Ventures, Veterans Health Administration--St. Louis and Cleveland, Trinity Health System, Providence St. Joseph Health-Swedish Health Services (Swedish), University of California, San Francisco
- Responsible party
- Principal investigator, Randy Brown, Mathematica Policy Research, Inc.
- Investigators
- Arkadipta Ghosh, PhD, Study director, Mathematica Policy Research, Inc.Randall S Brown, PhD, Principal investigator, Mathematica Policy Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212962
- Sponsor's protocol ID
- MathematicaPR
- Acronym
- TCM2020
- Status last verified
- Jul 2026
- First submitted
- 24 Dec 2019
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21471497Naylor 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.
PubMed 10029122Naylor 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.
PubMed 15086645McHugh 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.
PubMed 39582355Naylor 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.
PubMed 36709563
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Multisite Replication of the Transitional Care Model
- ClinicalTrials.gov ID
- NCT04212962
- Acronym / sponsor ID
- TCM2020 / MathematicaPR
- Conditions
- CHF - Congestive Heart Failure, COPD, Pneumonia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 962 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- University of Pennsylvania, Arnold Ventures, Veterans Health Administration--St. Louis and Cleveland, Trinity Health System, Providence St. Joseph Health-Swedish Health Services (Swedish), University of California, San Francisco
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Transitional care model (TCM)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 | Behavioral: Usual careThe control group receives usual discharge planning and post-discharge care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Treatment group |
| Usual careusual hospital discharge and post-discharge care | Behavioural | Control group |
Primary outcome
Number of hospital admissions
Time frame: 12 months
number of times admitted to the hospital during 12 months after initial discharge
Costs
Time frame: 12 months
Costs of medical care paid for by Medicare, Medicare Advantage plan, or Veterans Health Administration
8 secondary outcomes
30-day readmission
Time frame: 30 days
emergency department visits
Time frame: 12 months
length of time to death or hospital admission
Time frame: 12 months after initial discharge
Skilled nursing facility days
Time frame: 12 months after initial discharge
Mortality
Time frame: 12 months after initial discharge
Edmonton Symptom Assessment Scale
Time frame: 90 days after initial discharge
Patient-Reported Outcomes Measurement Information System Physical Functioning (SF10a)
Time frame: 90 days after initial discharge
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
Time frame: 90 days after initial discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 21471497Naylor 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.
- Background: PubMed 10029122Naylor 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.
- Background: PubMed 15086645Naylor 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.
- Derived from this study: PubMed 39582355McHugh 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.
- Derived from this study: PubMed 36709563Naylor 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.
- Individual participant dataSharing planned: No
Related trials for CHF - Congestive Heart Failure
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
Recruiting
Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP)
Acute Coronary Syndrome, Heart Failure
Recruiting
Peripheral Venous Pressure (PVP) Trial
Congestive Heart Failure
Not yet recruiting
Digital Outreach for Heart Failure Adherence
CHF - Congestive Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arkadipta Ghosh, PhD study director
Mathematica Policy Research, Inc.
Randall S Brown, PhD principal investigator
Mathematica Policy Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional care model (TCM) in people with CHF - Congestive Heart Failure and COPD, run by Mathematica Policy Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hospital admissions (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04212962, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.