SHIFT Team Intervention for Stroke

(SHIFT Trial)

Overseen By Olajide Williams, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Dementia, Major depression, Aphasia, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to enhance recovery and overall health for stroke survivors. The focus is on the SHIFT team intervention, which involves a community health worker, social worker, and nurse visiting patients at home to provide personalized support, such as medication management and addressing social challenges. This method is compared to the usual care stroke patients receive after hospital discharge. Suitable participants have experienced an ischemic stroke, face social or economic challenges, and plan to recover at home in New York City. As an unphased trial, this study offers a unique opportunity to explore innovative recovery methods and receive personalized support at home.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the SHIFT team intervention is safe for stroke patients?

Research shows that the SHIFT team intervention helps stroke patients by offering personalized care from a team that includes community health workers, social workers, and nurses. This approach aims to improve patients' overall health by addressing social factors that can impact recovery.

Specific safety data for the SHIFT intervention itself is not available. However, because it involves non-invasive support like home visits, counseling, and help with managing medications, it is generally considered low-risk. Non-invasive means it doesn't involve surgery or inserting anything into the body.

Additionally, earlier studies have shown that similar support programs are usually well-received by patients. These interventions typically aim to improve patient care without introducing new drugs or medical devices, which often reduces safety concerns.

Overall, while detailed safety data for the SHIFT intervention is lacking, its focus on support and education suggests it is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SHIFT team intervention for stroke recovery because it tackles recovery in a comprehensive and innovative way. Unlike standard care, which primarily involves educational materials and follow-up appointments, this intervention includes a dedicated team of a community health worker, social worker, and nurse who make home visits soon after hospital discharge. They focus not only on medical needs but also address social determinants of health, offering personalized support and education. This holistic approach aims to improve medication management, risk factor control, and overall health literacy, which could lead to better recovery outcomes for stroke patients.

What evidence suggests that the SHIFT team intervention is effective for stroke patients?

Research has shown that the SHIFT team intervention, which participants in this trial may receive, can aid stroke patients in better recovery. This approach targets conditions impacting health and quality of life. Studies have found that SHIFT enhances communication and patient safety, crucial for recovery. Early results suggest this method can improve abilities such as mobility and daily task performance, and it may also help manage risk factors like high blood pressure. Additionally, the intervention aims to boost memory and thinking skills after a stroke. While more research is needed, these early findings are promising for improving recovery in stroke patients. ^{2 6 7 8 9}

Who Is on the Research Team?

Richard T Benson, MD

Principal Investigator

NINDS Office of Global Health and Health Disparities

Are You a Good Fit for This Trial?

This trial is for African American and Hispanic stroke patients aged 18-75 who face at least three social determinants of health risks. It's not specified who can't join, but typically those with conditions that could interfere with the study or its results might be excluded.

Inclusion Criteria

I was mostly independent before my stroke.

I can understand and agree to the study details before leaving the hospital after a stroke.

African American/Black or Hispanic race-ethnicity

Exclusion Criteria

Aphasia severe enough to preclude initial examination

Life expectancy less than 1 year

I have been diagnosed with major depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

The SHIFT intervention team conducts home visits within 72 hours of hospital discharge to address SDOH barriers, provide counseling, and assist with medication management.

6 months

Regular home visits

Follow-up

Participants are monitored for functional, physiological, and epigenetic outcomes at 6 months and 1 year post-stroke.

1 year

Follow-up clinic appointments at 4-6 weeks, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• SHIFT team intervention

Trial Overview The SHIFT team intervention is being tested to see if it improves functional outcomes (measured by the Stroke Impact Scale), physiological outcomes like blood pressure and cognition, and explores changes in stress-related biomarkers compared to usual care.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The SHIFT intervention team, comprising a community health worker (CHW), community social worker (CSW), and community nurse (CN),will make a first home visit within 72 hours of hospital discharge, and make regular visits to address SDOH barriers identified for each patient, provide individualized counseling, and assist with medication management, risk factor control, and health literacy.

Group II: Usual Care Active Control 1 Intervention

All patients will be given standard discharge information, including culturally/racially sensitive stroke education materials for post-stroke care, signs and symptoms of acute stroke, and management of stroke risk factors. Homecare referrals and other rehabilitation services will continue to be provided to discharged patients according to standard-of-care and treating physician referrals. Follow up clinic appointments at 4-6 weeks post discharge will be made with a stroke neurologist per clinical protocol. Thus the only difference between intervention and usual care will be the SHIFT intervention.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

The TeamSTEPPS program, inspired by safety practices from high-risk industries, aims to enhance patient safety in healthcare by promoting teamwork and effective communication among healthcare professionals.

Evidence shows that implementing TeamSTEPPS can improve safety and patient outcomes by shifting healthcare workers' focus from individual expertise to collaborative team performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The TeamSTEPPS Approach to Safety and Quality. Epps, HR., Levin, PE.[2022]

A case-based discussion of thrombolysed cases with the entire neurologic staff significantly reduced the door-to-needle time for stroke patients from 37 minutes to 28 minutes, indicating improved efficiency in treatment delivery.

The intervention was effective for both less experienced residents and more experienced specialists, with specialists showing greater improvements, suggesting that team-based education can enhance stroke care in both academic and primary settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Talk About Thrombolysis. Regular Case-Based Discussions of Stroke Thrombolysis Improve Door-to-Needle Time by 20. Klingner, C., Günther, A., Brodoehl, S., et al.[2019]

Implementing a structured stroke team algorithm and simulation training significantly reduced the median door-to-needle time for thrombolysis in stroke patients by 12 minutes, improving timely treatment.

The intervention increased the percentage of patients receiving thrombolysis within 30 minutes of arrival at the hospital from 41.5% to 59.6%, while also enhancing the knowledge and perception of patient safety among stroke team members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of stroke teams and simulation training shortened process times in a regional stroke network-A network-wide prospective trial. Tahtali, D., Bohmann, F., Kurka, N., et al.[2018]

In a study of 150 stroke patients, 170 adverse events (AEs) and no-harm incidents were identified, affecting over half of the patients, highlighting the high incidence of patient harm in stroke care.

The most common AEs included ischemic strokes and urinary tract infections, with a significant portion of medication events being preventable, indicating a need for improved safety measures in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence of No-Harm Incidents and Adverse Events in Hospitalized Patients with Ischemic Stroke or TIA: A Cohort Study Using Trigger Tool Methodology. Nowak, B., Schwendimann, R., Lyrer, P., et al.[2022]

A study found that about 25% of medical emergency team activations in hospitals were linked to preventable adverse events, highlighting a significant area for improvement in patient safety.

This research utilized real-time evaluations of patient charts during emergency consultations, which proved to be more effective in identifying issues than traditional retrospective reviews, suggesting a more efficient approach to enhancing care quality without requiring extensive additional resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolving story of medical emergency teams in quality improvement. Amaral, AC., Shojania, KG.[2021]

In a study of 65 Medical Emergency Team (MET) calls over four weeks, 24% were identified as preventable adverse events, highlighting the potential for METs to improve patient safety by systematically identifying errors.

The most common cause of these preventable events was errors in providing appropriate therapy despite having an accurate diagnosis, indicating a need for better communication and treatment protocols in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Medical Emergency Teams to detect preventable adverse events. Iyengar, A., Baxter, A., Forster, AJ.[2021]

A feasibility study involving 91 stroke patients demonstrated that stroke unit management principles can be effectively applied in general wards, coordinated by a multidisciplinary team with minimal additional staffing requirements.

The implementation of this service led to faster referrals to therapy and significantly increased access to speech (49%) and occupational therapy (80%) compared to other medical wards, highlighting its potential benefits for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mount Vernon stroke service: a feasibility study to determine whether it is possible to apply the principles of stroke unit management to patients and their families on general medical wards. Stone, SP.[2019]

Implementing a nurse-led bedside report instead of traditional group shift reports led to significant time savings during shift changes, which also resulted in reduced overtime costs.

The new reporting process contributed to improved patient safety, evidenced by a decrease in patient falls and call light usage during shift changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardization of change-of-shift report. Athwal, P., Fields, W., Wagnell, E.[2019]

Relocating nursing shift reports to the patient's bedside led to reduced report times, indicating a more efficient communication process among nurses.

The intervention also improved nursing satisfaction, suggesting that bedside reporting can enhance the work environment for nursing staff despite initial challenges like privacy and distractions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bedside shift-to-shift nursing report: implementation and outcomes. Evans, D., Grunawalt, J., McClish, D., et al.[2019]

While many health professionals support the idea of team care for stroke patients, there is a lack of definitive experimental evidence to fully validate its benefits, although some studies suggest that certain stroke patients do benefit from this approach.

The review highlights the need for more rigorous research to better understand how to effectively implement team care in stroke treatment, while also providing useful guidelines from existing descriptive reports on organizing and administering such care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team care following stroke; what does it accomplish? Wood-Dauphinee, S.[2009]

The study aims to improve acute stroke care processing times through a multi-level intervention involving workflow revisions and 2-3 simulation training sessions at 7 neurocenters in Germany, focusing on interdisciplinary team performance.

The primary outcome measure is the 'door-to-needle' time for stroke patients receiving IV thrombolysis, with secondary outcomes assessing process times for endovascular therapy and improvements in team communication, patient safety, and staff satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation-Based Training of the Rapid Evaluation and Management of Acute Stroke (STREAM)-A Prospective Single-Arm Multicenter Trial. Bohmann, FO., Kurka, N., du Mesnil de Rochemont, R., et al.[2020]

The NINDS rt-PA Stroke Trial showed that timely intervention with thrombolytics can significantly reduce neurological deficits in stroke patients, yet less than 1.5% of acute stroke victims currently receive this treatment, highlighting the need for improved acute stroke care.

Telestroke technology offers a promising solution to enhance access to expert stroke care, allowing remote consultations and education for healthcare professionals, which could increase the number of patients receiving effective treatment and improve overall stroke care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Telestroke" : the application of telemedicine for stroke. Levine, SR., Gorman, M.[2023]

Multidisciplinary in-hospital teams significantly reduce adverse events and improve patient outcomes by enhancing communication and teamwork among healthcare workers, as shown in various settings like emergency rooms and operating rooms.

These teams not only maximize patient safety and satisfaction but also decrease the length of hospital stays and improve job satisfaction for healthcare workers, highlighting the importance of maintaining cohesive teams in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary in-hospital teams improve patient outcomes: A review. Epstein, NE.[2022]

Implementing bedside change-of-shift reporting in a stroke rehabilitation unit improved communication during shift transitions, which is crucial for enhancing patient safety and reducing sentinel events.

This approach also encourages patient involvement in their care decisions, aligning with patients' desires to be more engaged in their treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating bedside reporting into change-of-shift report. Laws, D., Amato, S.[2019]

This study aims to rigorously evaluate the effectiveness of bedside shift reporting in hospitals, focusing on its impact on patient participation and communication among nurses, using a controlled, mixed-method design involving both qualitative and quantitative assessments.

The research will utilize a comprehensive framework to assess feasibility, appropriateness, and meaningfulness, highlighting the importance of improving patient care through enhanced communication strategies in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, appropriateness, meaningfulness and effectiveness of patient participation at bedside shift reporting: mixed-method research protocol. Malfait, S., Eeckloo, K., Lust, E., et al.[2019]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11012850

The SDOH-Homecare Intervention Focus Team (SHIFT ... Specifically, we will examine the effect of the SHIFT approach on post-stroke outcomes of African American and Hispanic patients with > 3 SDOH risk factors ...

2. withpower.com withpower.com/trial/phase-stroke-5-2024-ec252

SHIFT Team Intervention for Stroke (SHIFT Trial) The SHIFT team intervention, which includes bedside shift reporting, has been shown to improve communication and patient safety, reduce time spent on shift ...

3. ctv.veeva.com ctv.veeva.com/study/sdoh-homecare-intervention-focus-team-shift-trial-to-improve-stroke-outcomes

SDOH-Homecare Intervention Focus Team (SHIFT) Trial to ... To test the hypothesis that among stroke patients 18-75 years with ≥3 SDOH risk factors, SHIFT will improve: (1) functional outcomes as measured by the SIS ( ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211335525000889

Efficacy of the HOBIT program - a cluster randomized trial The intervention effect was 16 % (95 % CI 12–21) for knowledge, 10 % (95 % CI 4–15) for self-efficacy,10 % (95 % CI 5–15) for outcome expectations, 8 % (95 % CI ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11475721/

Streamlining Acute Stroke Processes and Data Collection The aim of this study is to analyze the existing literature reviewing stroke treatment processes in primary and comprehensive stroke centers that investigated ...

6. trialstoday.org trialstoday.org/trial/NCT06397937

SDOH-Homecare Intervention Focus Team (SHIFT) Trial to ... Primary Goal: To test the hypothesis that among stroke patients 18-75 years with ≥3 SDOH risk factors, SHIFT will improve: (1) functional ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8729165/

Night and shift work and incidence of cerebrovascular ... The risk of incident stroke was statistically significantly increased among employees who frequently (>15 times per year) worked ≥3 consecutive night shifts and ...

8. ahajournals.org ahajournals.org/doi/10.1161/STR.0000000000000495

Targeted Nursing Interventions for Improving Stroke Care ... The stroke coordinator should acquire robust data practices to guide hospital stroke care processes, resulting in improved patient outcomes.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2677490/

Treatment effects for which shift or binary analyses are ... In acute stroke trials, functional outcome may be analyzed by dichotomizing ordinal outcome scales or by evaluating the entire scale range (shift analysis).