CTraC-FIT for Functional Impairment

(CTraC-FIT Trial)

Overseen By Caroline Madrigal, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Acute psychiatric care, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines ways to help older Veterans recover more effectively after hospital discharge. The goal is to test a new care plan called CTraC-FIT, which includes specialized support from nurses to help Veterans regain independence and avoid hospital readmission. The trial compares this new care plan to the usual care Veterans receive. Veterans who may be suitable for this trial are those aged 65 or older, with some physical limitations, and planning to return directly home after their hospital stay. As an unphased trial, this study offers Veterans the chance to contribute to innovative care strategies that could enhance recovery for many.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CTraC-FIT protocol is safe for Veterans?

Research shows that the CTraC program, on which CTraC-FIT is based, has been well-received. Studies indicate that this nurse-led program, providing care over the phone, effectively reduces hospital readmissions for veterans. No major reports of negative effects from the program have emerged. This suggests that CTraC-FIT, being similar, is expected to be safe for participants. The program aims to help veterans enhance their abilities after hospital discharge, focusing on a safe and smooth transition from hospital to home. Participants can feel reassured by the program's history of successful and safe use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CTraC-FIT because it offers a new approach to improving functional abilities and reducing hospital readmissions for patients. Unlike standard care, which typically involves in-person visits and traditional follow-ups, CTraC-FIT is delivered via phone or VA Video Connect by a trained nurse case manager, making it more accessible and convenient for patients. This method not only enhances patient engagement but also supports smoother transitions from hospital to home, targeting a critical period when patients are often vulnerable to setbacks.

What evidence suggests that the CTraC-FIT protocol is effective for improving functional recovery in older Veterans?

Research shows that the CTraC program, on which CTraC-FIT is based, has successfully reduced hospital readmissions. Nurses lead this program, assisting veterans in transitioning from hospital to home, often through phone support. Studies have found that CTraC helps veterans with serious illnesses by coordinating their care and improving health outcomes. In this trial, participants in the CTraC-FIT arm will receive a structured transitional care intervention aimed at enhancing functional abilities and reducing hospital readmissions. CTraC-FIT builds on the original program by focusing more on helping veterans regain independence and maintain quality of life. Although specific data on CTraC-FIT's effectiveness is not yet available, the success of the original CTraC program provides a strong foundation. ^{1 2 3 5 6}

Who Is on the Research Team?

Caroline Madrigal, PhD

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Are You a Good Fit for This Trial?

This trial is for older Veterans who have functional impairments and are transitioning from hospital to home. It's designed to help them regain and maintain independence after hospitalization.

Inclusion Criteria

I am 65 years old or older.

Able to provide informed consent

My physical ability score is between 4 and 9.

Exclusion Criteria

Plan to discharge anywhere except home (e.g., assisted living, group home, or skilled nursing facility)

Admitted to VA Boston for acute psychiatric care or substance abuse detoxification

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

CTraC-FIT Intervention

Participants receive a structured transitional care intervention (CTraC-FIT) administered by a trained nurse case manager via phone or VA Video Connect, aimed at improving functional abilities and reducing hospital readmissions.

4 weeks

Phone or VA Video Connect sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of physical, cognitive, and social function.

3 months

Assessments at baseline, endpoint, and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• CTraC-FIT

Trial Overview The study is testing a new protocol called CTraC-FIT, which adds targeted assessment and intervention strategies focused on functional recovery to the existing Coordinated Transitional Care (CTraC) program.

How Is the Trial Designed?

Group I: Enhanced Usual Care Experimental Treatment 1 Intervention

The Enhanced Usual Care (EUC) arm involves participants receiving the standard care provided by their assigned Veterans Affairs Boston Healthcare System (VABHS) inpatient and outpatient teams.

Group II: CTraC-FIT Experimental Treatment 1 Intervention

The intervention arm involves participants receiving a structured transitional care intervention (CTraC-FIT) administered by a trained nurse case manager via phone or VA Video Connect, aimed at improving functional abilities and reducing hospital readmissions.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07132944

NCT07132944 | Development and Feasibility of CTraC-FIT The intervention arm aims to improve functional abilities and reduce hospital readmissions by providing tailored support based on the unique ...

2. agsjournals.onlinelibrary.wiley.com agsjournals.onlinelibrary.wiley.com/doi/full/10.1111/jgs.70110

Perspectives of Nurses in the VA Coordinated Transitional ... CTraC readmission data typically demonstrate the program's robust effect on lowering readmissions and have been used by facility leadership ...

3. ctv.veeva.com ctv.veeva.com/study/development-and-feasibility-of-ctrac-fit

Development and Feasibility of CTraC-FIT - ClinicalTrials.Veeva This project aims to develop and test a function-focused CTraC protocol (CTraC-FIT) to address this critical gap and optimize functional outcomes for Veterans ...

4. researchgate.net researchgate.net/publication/372369286_Nurse-led_supportive_Coordinated_Transitional_Care_CTraC_program_improves_care_for_veterans_with_serious_illness

(PDF) Nurse-led supportive Coordinated Transitional Care ... Background: The Coordinated Transitional Care (CTraC) program is a telephone-based, nurse-driven program shown to decrease readmissions.

5. healthaffairs.org healthaffairs.org/doi/abs/10.1377/hlthaff.2012.0366

Low-Cost Transitional Care With Nurse Managers Making ... The Coordinated-Transitional Care (C-TraC) Program was designed to improve care coordination and outcomes among veterans with high-risk conditions ...

6. reporter.nih.gov reporter.nih.gov/search/15E9CD084689C2D07598B8961CAA4A01A2FFCEB861BF/project-details/10906045

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