Transitional Care Program for Stroke Survivors

Recruiting at 2 trial locations

Overseen By Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Syntrillo, Inc

Disqualifiers: Hemorrhagic stroke, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

224 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the Transitional Care Program can help stroke survivors manage their health to prevent another stroke. The researchers aim to determine if starting the program immediately after hospital discharge is more effective than beginning it a few months later. Participants will use smart devices to track medication, exercise, and health information, with regular check-ins with healthcare providers. This trial suits adults who have experienced an ischemic stroke (a stroke caused by a blocked blood vessel) and can maintain health tracking and virtual visits. As an unphased trial, it offers participants the chance to contribute to innovative care strategies that could enhance recovery and prevent future strokes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, as participants are asked to keep track of them during the study.

What prior data suggests that this transitional care program is safe for stroke survivors?

Research has shown that programs assisting stroke survivors in transitioning from hospital to home are safe. These programs can enhance physical abilities, quality of life, and confidence in health management. No major reports of negative effects have emerged, indicating participants generally tolerate them well.

One study examined stroke survivors returning home and found improved physical and mental health without serious side effects. Another study tested various methods to aid this transition and also found them safe for stroke survivors.

Overall, evidence suggests these programs are safe and beneficial for managing health after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike typical stroke recovery methods that focus primarily on medication and physical therapy, the Transitional Care Program is unique because it emphasizes a seamless transition from hospital to home for stroke survivors. Researchers are excited about this program because it offers personalized support at two critical times: right after hospital discharge and a few months later, ensuring that patients receive continuous care tailored to their evolving needs. This approach aims to reduce readmissions and improve long-term recovery outcomes by addressing the often-overlooked challenges patients face after leaving the hospital.

What evidence suggests that this transitional care program is effective for stroke survivors?

This trial will compare two different enrollment timings for a Transitional Care Program for stroke survivors. Studies have shown that transitional care programs can greatly improve the lives of stroke survivors. Research indicates that these programs, especially when led by nurses, enhance participants' quality of life over a year. They focus on education and support, which can boost physical abilities and confidence in managing health. One study found that transitioning from hospital to home with transitional care is more effective than standard care in everyday situations. By concentrating on these areas, transitional care programs aim to help stroke survivors better manage risk factors and lower the chance of having another stroke. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for stroke survivors who've been discharged from the hospital. It's designed to see if a special care program helps them manage their health and prevent another stroke by following American Heart Association guidelines.

Inclusion Criteria

All Cohorts: Evidence of ischemic stroke documented on CT or MRI

Late Enrollment: Stroke survivors previously admitted at the participating sites' inpatient stroke unit

I am 30 years old or older.

Exclusion Criteria

Participants with a diagnosis of dementia will be excluded

Participants determined to have hemorrhagic or periprocedural stroke based on hospital EMR review will be excluded

Participants determined to have an ischemic stroke due to dissection based on hospital EMR review will be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transitional Care Program

Participants track medications, exercise, and health information using smart devices, answer health and lifestyle questions, and meet with healthcare providers

6 months

Regular virtual check-ins and device monitoring

Follow-up

Participants are monitored for safety and effectiveness after the transitional care program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transitional Care Program

Trial Overview The study tests a Transitional Care Program, comparing its effectiveness when started immediately after discharge versus starting 3-5 months later. Participants use smart devices to monitor health and meet with healthcare providers.

How Is the Trial Designed?

Group I: Late Enrollment Experimental Treatment 1 Intervention

Participants enrolled mainly between 3-5 months after their discharge from the hospital following an ischemic stroke.

Group II: Early Enrollment Experimental Treatment 1 Intervention

Participants enrolled around the time of discharge from the hospital immediately following an ischemic stroke.

Who Is Running the Clinical Trial?

Syntrillo, Inc

Lead Sponsor

Trials

1

Recruited

220+

Published Research Related to This Trial

Patients with advanced cirrhosis face significant risks, including portal hypertension, which can lead to severe complications like hemorrhage, infection, and renal failure, making critical care management essential.

Liver transplantation offers a potential cure for selected patients with decompensated cirrhosis, highlighting the need for careful and proactive treatment in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of chronic liver disease. Chung, RT., Jaffe, DL., Friedman, LS.[2004]

In a study of 90 cirrhotic patients with hepatitis C, those with clinically significant portal hypertension had a much lower rate of sustained virologic response (14%) compared to those without it (51%), highlighting the impact of portal hypertension on treatment efficacy.

Hepatovenous pressure gradient (HVPG) was found to be a strong independent predictor of treatment response, outperforming other factors like liver stiffness and baseline HCV RNA levels, suggesting that measuring HVPG should be a key part of evaluating cirrhotic patients for antiviral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portal pressure predicts outcome and safety of antiviral therapy in cirrhotic patients with hepatitis C virus infection. Reiberger, T., Rutter, K., Ferlitsch, A., et al.[2023]

Outpatient interventions, such as dietary sodium restriction and diuretics, can significantly reduce preventable hospitalizations for cirrhotic patients experiencing fluid retention, based on a review of 17 studies involving 1,694 patients.

The review identified six effective outpatient management strategies, including daily weight monitoring and albumin infusions, which can help manage fluid retention and improve patient outcomes without the need for hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient interventions for hepatology patients with fluid retention: a review and synthesis of the literature. White, A.[2018]

Hepatic encephalopathy (HE) significantly worsens outcomes for patients with cirrhosis, leading to higher rates of hospital readmission and mortality, highlighting the need for effective management strategies.

Combining lactulose with rifaximin and implementing supportive care initiatives, such as patient education and telemedicine, can improve post-discharge outcomes and reduce readmission rates for patients with HE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatic Encephalopathy-Related Hospitalizations in Cirrhosis: Transition of Care and Closing the Revolving Door. Frenette, CT., Levy, C., Saab, S.[2022]

Hepatic encephalopathy is a major cause of hospital readmissions for patients with liver cirrhosis, highlighting the need for effective management strategies.

Implementing bundled care approaches, like the 'Ideal Transitions of Care' model, along with early follow-up and nonphysician team involvement, can significantly reduce readmissions and improve patient transitions to outpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatic encephalopathy and strategies to prevent readmission from inadequate transitions of care. Rosenstengle, C., Kripalani, S., Rahimi, RS.[2022]

A systematic review of 21 studies involving 2069 older adults showed that 80% of participants in Transition Care Programmes (TCP) were successfully discharged home, indicating a positive outcome for this intervention.

There was a significant improvement in the ability to perform daily activities among older adults in TCP, with an average increase of 17.65 points on the Modified Barthel Index, suggesting that TCP can enhance functional recovery after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of facility-based transition care on health-related outcomes for older adults: A systematic review and meta-analysis. Hang, JA., Naseri, C., Francis-Coad, J., et al.[2021]

Transitional care programs for injured adults, particularly those led by nurses or social workers, significantly improved follow-up adherence by 75% and reduced readmission rates by 5% compared to historical data.

These programs, which often include post-discharge phone calls and interdisciplinary case coordination, can effectively decrease emergency department visits by 13%, indicating their potential to enhance patient care and reduce healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitional care programs for trauma patients: A scoping review. Shilati, FM., Silver, CM., Baskaran, A., et al.[2023]

A nurse-led transitional care program (TCP) for stroke patients significantly improved quality of life, particularly in physical and mental health, compared to a control group, with notable effects observed at 4 weeks post-discharge.

Patients in the TCP group experienced lower rates of hospital readmissions and emergency room visits, along with better overall satisfaction and reduced depression scores, highlighting the program's effectiveness in supporting stroke survivors after leaving the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 4-week transitional care programme for discharged stroke survivors in Hong Kong: a randomised controlled trial. Wong, FK., Yeung, SM.[2022]

The MELD-Plus risk score, developed from a study of 314,292 patients with cirrhosis-related admissions, significantly improves the prediction of 90-day mortality compared to traditional MELD and MELD-Na scores, enhancing prediction accuracy by up to 16.9%.

This new model utilizes nine key variables, including components of MELD-Na, to effectively identify high-risk patients, allowing for better treatment planning and potentially reducing mortality rates after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The MELD-Plus: A generalizable prediction risk score in cirrhosis. Kartoun, U., Corey, KE., Simon, TG., et al.[2020]

In a study involving 199 participants aged over 60 with multiple health issues, the Mayo Clinic Care Transitions (MCCT) program did not show a significant improvement in quality of life (QoL) compared to usual care after one year.

While 74% of MCCT participants reported good-to-excellent QoL at baseline, this dropped to 64% after one year, indicating a potential decline in QoL that may be due to the progression of chronic diseases rather than the effectiveness of the MCCT program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient quality of life in the Mayo Clinic Care Transitions program: a survey study. Faucher, J., Rosedahl, J., Finnie, D., et al.[2020]

Recent research highlights innovative strategies to enhance cirrhosis care, including the use of technology like virtual care and smartphone applications, as well as engaging caregivers and non-physicians in outpatient settings.

Inpatient care improvements focus on interdisciplinary teams and education, while post-discharge strategies involve care coordinators and day hospitals, demonstrating a comprehensive approach to managing cirrhosis across different healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to Improve Delivery of Cirrhosis Care. Moghe, A., Yakovchenko, V., Morgan, T., et al.[2022]

In a study of post-stroke patients transferred to transitional care over eight years, predictions of discharge destinations made by medical and multidisciplinary teams were accurate only 60% of the time, despite a high agreement rate (κ = 0.87).

The study found that functional improvement, as measured by the Modified Barthel Index, was the most reliable predictor of a patient's final discharge destination, rather than demographic factors like age or type of stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostication accuracy of final destination in poststroke patients requiring transitional care. Iddagoda, MT., Inderjeeth, CA., Chan, K., et al.[2021]

Cirrhotic patients who received outpatient telephonic transitional care (OTTC) after hospital discharge had a significantly higher 6-month survival rate (84.2%) compared to those who did not receive OTTC (68.8%), indicating that this intervention may improve long-term outcomes.

Despite the improved survival, the readmission rates at 1, 3, and 6 months were similar between the OTTC group and the control group, suggesting that readmission rates may not be a reliable measure of the quality of care or the effectiveness of transitional care programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient telephonic transitional care after hospital discharge improves survival in cirrhotic patients. Rao, BB., Sobotka, A., Lopez, R., et al.[2020]

Advanced liver disease, particularly cirrhosis, is increasingly common in the U.S. due to factors like nonalcoholic fatty liver disease and hepatitis C, leading to significant hospital admissions.

To reduce readmission rates, it's crucial to focus on high-risk cirrhosis patients, such as those with high Model for End-Stage Liver Disease scores and comorbidities, and to apply management strategies similar to those used in heart failure care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Burden of Rehospitalization for Patients With Liver Cirrhosis. Desai, AP., Reau, N.[2016]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.122.039565

Care Transition Interventions to Improve Stroke Outcomes The full return to usual community activities should be regarded as the best most comprehensive measure of successful stroke care and recovery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11871394/

The Effectiveness of Nurse‐Led Transition Care on Post ... The pooled results show that stroke survivors who were allocated to nurse‐led TC programs had a 1‐year better quality of life compared to those allocated to ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1062030325000342

The transitional care from hospital to home for stroke ... This study supports educational and informative interventions to improve the physical functioning, quality of life, and self-efficacy of stroke survivors.

4. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-023-04403-1

The stroke transitional care intervention for older adults with ... This study aimed to test, in real-world clinical practice, the effectiveness of a Transitional Care Stroke Intervention (TCSI) compared to usual care.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824531

Rehabilitation Transition Program to Improve Community ... This randomized clinical trial of stroke survivors compares the efficacy of a rehabilitation transition program with attentional control to ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK616938

Comparing Programs to Support Stroke Survivors and Their ... To improve patient outcomes during the transition between hospital and home by testing 2 interventions: (1) a 60-day home-based social work case management ( ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06657235?cond=Metastasis%20risk%20factors&aggFilters=status:not%20rec%20ava&viewType=Table&rank=8

Transitional Care Program to Improve Risk Factors ... The goal of this clinical trial is to evaluate whether our transitional care program helps stroke survivors better manage their risk factors for stroke to ...