Transition Program for Stroke

(COMPASS 3 Trial)

Recruiting at 1 trial location

Overseen By Brianna Holden, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Cognitive impairment, Communication problem, others

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

Compensation: Varies

Number of Visits: Unknown

520 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals who have recently experienced a stroke in transitioning from hospital rehabilitation to home life. It will compare two programs: the Education Program, which focuses on teaching about stroke signs, risks, and prevention, and COMPASS, which involves occupational therapy to make home environments safer and easier to navigate. Individuals who were independent in daily tasks before their stroke and plan to return home from rehab may be suitable candidates. Participants should be able to understand and agree to the study's requirements. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance post-stroke recovery programs.

Do I need to stop taking my current medications for this 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 this program is safe for stroke patients transitioning to home?

Research has shown that the COMPASS program helps people recover at home after a stroke. Studies have found that this program eases access to community resources and aids in managing health at home, such as monitoring blood pressure.

These studies do not report any safety issues or negative effects specifically related to the COMPASS program. Instead, the program has been linked to positive outcomes, such as reducing the need for admission to a skilled nursing facility. This suggests that the program is well-received and beneficial for patients without causing harm.

Overall, although specific safety data is limited, the COMPASS program appears to be a safe option for assisting people in returning home after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Transition Program for Stroke because it introduces innovative approaches to post-stroke care. Unlike traditional treatments that mainly focus on medication and standard rehabilitation, the COMPASS intervention offers a unique combination of evidence-based strategies that include home visits by occupational therapy practitioners. This approach aims to address barriers within the home and community, which can significantly impact daily activities and community participation for stroke survivors. Additionally, the Education Program provides tailored guidance based on "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home," helping patients understand stroke symptoms and risk factors to prevent recurrence. This holistic focus on both environment and education sets these programs apart from existing options.

What evidence suggests that this trial's treatments could be effective for stroke recovery?

Research has shown that the COMPASS program, one of the interventions in this trial, assists stroke survivors in transitioning from the hospital to home. It effectively lowers the risk of death and reduces the need for nursing home care. Participants in COMPASS reported improvements in daily activities and greater satisfaction with their recovery. This program also removes obstacles at home and in the community, facilitating a smoother return to normal life for stroke survivors. Overall, COMPASS has demonstrated promising results in aiding this transition. Another arm of this trial involves an Education Program, which provides stroke survivors with information on stroke symptoms, risk factors, and preventing stroke recurrence. ^{5 6 7 8 9}

Who Is on the Research Team?

Susan Stark, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals transitioning from inpatient rehabilitation to home after suffering an ischemic or hemorrhagic stroke. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions.

Inclusion Criteria

I was independent in daily activities before my stroke.

I will be going home after my interventional radiology procedure.

Capable of giving informed consent which includes compliance with the requirements and duration of participation as listed in the Informed Consent Form (ICF)

Exclusion Criteria

Any communication problem that would prevent study completion

Residence in a congregate living facility

Not eligible for a therapeutic pass

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transition Program

Participants transition from inpatient rehabilitation to home, receiving either a stroke education program or an environmental modifications program

12 months

Home visits by an occupational therapy practitioner

Follow-up

Participants are monitored for safety and effectiveness after the transition program

12 months

What Are the Treatments Tested in This Trial?

Interventions

• COMPASS
• Education Program

Trial Overview The study compares two post-stroke transition programs: a standard stroke education program versus an environmental modifications program called COMPASS. Participants will be randomly assigned to one of these two groups.

How Is the Trial Designed?

Group I: COMPASS intervention Experimental Treatment 1 Intervention

COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation.

Group II: Education Program Placebo Group 1 Intervention

A research team member will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topics may include stroke symptoms, risk factors and preventing stroke recurrence.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11374483/

The Community Participation Transition after Stroke ... The COMPASS intervention reduced the risk of death and SNF admission among post-stroke survivors compared to an attentional control group. Risk of 30-day ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0003999325010214

A process evaluation of a randomized controlled trial of an ... COMPASS had good reach and was effective in improving stroke survivors' self-rated performance and satisfaction and in reducing environmental ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.040736

Disparities in Community‐Based Rehabilitation Following ... We conducted an observational, secondary analysis of data from the COMPASS (Comprehensive Post‐Acute Stroke Services) trial, linking data of ...

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

Rehabilitation Transition Program to Improve Community ... COMPASS reduced environmental barriers and improved performance of daily activities for stroke survivors as they transitioned from inpatient ...

5. pcori.org pcori.org/research-results/2015/comparing-care-program-and-usual-care-help-patients-transition-home-hospital-after-stroke-compass-study

The COMPASS Study In this study, the research team wanted to learn if a care program called COMPASS-TC helped stroke survivors recover after leaving the hospital.

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.118.035864

Stroke Outcomes in the COMPASS Trial | Circulation Strokes were significantly reduced by the combination of rivaroxaban plus aspirin in comparison with aspirin in the COMPASS trial.

7. school.wakehealth.edu school.wakehealth.edu/departments/neurology/compass-study

COMPASS Study | Wake Forest University School of Medicine The COMPASS Study evaluated a patient-centered, community-based care model to improve secondary prevention, recovery and access to community resources for ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5513078/

The Comprehensive Post-Acute Stroke Services (COMPASS ... The COMPASS care model intervention uses a holistic approach and integrates medical and community resources to meet the needs of stroke ...

9. valueinhealthjournal.com valueinhealthjournal.com/article/S1098-3015(23)03035-8/fulltext

Postacute Expenditures Among Patients Discharged Home ... COMPASS improved home blood pressure monitoring relative to patients receiving usual care (adjusted odds ratio [OR] 1.43, 95% CI 1.21-1.70).