PCORI has identified the need for large studies that look at real-life questions faced by diverse patients, caregivers, and clinicians. To address this need, PCORI launched the Pragmatic Clinical Studies initiative in 2014. Pragmatic clinical studies allow for larger-scale studies with longer timelines to compare the benefits and harms of two or more approaches known to be effective for preventing, diagnosing, treating, or managing a disease or symptom. They focus on everyday care for a wide range of patients. This research project is one of the studies PCORI awarded as part of this program.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
According to the Centers for Disease Control and Prevention, more than 795,000 people in the United States have a stroke each year. Stroke survivors often have a hard time with daily activities, such as bathing or walking. Stroke survivors often express the view that the care and support they receive after leaving the hospital doesn’t meet their needs. For example, patients may have to visit several clinics and other facilities to get care after leaving the hospital.
This study compares two ways of caring for people who have recently had a stroke:
- Normal follow-up care
- A program called COMPASS (Comprehensive Post-Acute Stroke Services) that supports patients after leaving the hospital by giving them rehabilitation at home and helping with follow-up care and community support services
Who can this research help?
This research can help doctors and hospital staff decide how to care for stroke survivors and their families. It can also help stroke survivors and their families understand care options.
What is the research team doing?
The research team is working with more than 5,000 patients at 41 hospitals in North Carolina. During the first part of the study, the researchers assign half of the hospitals by chance to use the COMPASS program to care for stroke survivors. The other half give normal follow-up care to stroke survivors.
Hospitals using the COMPASS program are creating care plans for each patient to help manage stroke recovery at home. Staff members at COMPASS hospitals call stroke survivors two days after they leave the hospital. The staff follows up with survivors again after 30 and 60 days. Patients have a follow-up appointment at a clinic within two weeks. A nurse finds out what types of activities patients can do and sets up a care plan based on each patient’s needs. A nurse also works with community organizations and services to help stroke survivors get support, such as help with cooking or transportation, during their recovery.
The research team is developing a scorecard for doctors and staff in COMPASS hospitals that allows them to see how well they’re doing in helping stroke survivors recover.
During the second part of the project, all hospitals use the COMPASS program.
The researchers call patients 90 days after they leave COMPASS hospitals. They ask patients about their daily activities. Researchers also find out if participants:
- Take medicines as needed
- Go back to the hospital
- Use resources in the community that can support them
- Go to follow-up appointments
- Have depression or other health concerns
- Have caregivers who feel strained
A year after the stroke, the research team follows up to learn whether participants:
- Have had another stroke
- Have been hospitalized
- Have been admitted to a nursing home or rehab facility
- Have had follow-up appointments with their doctors
- Have died from any cause
The research team is working with community groups to get advice on how to carry out the study. They are also looking for advice on how the findings of the study could help in other hospitals around the country. Partners include the North Carolina Stroke Care Collaborative, American Stroke Association/American Heart Association, North Carolina Stroke Advisory Council, Justus-Warren Heart Disease and Stroke Prevention Task Force, the East Carolina University Center for Health Disparities, and the North Carolina Area Agencies on Aging.
Research methods at a glance
|Study Design||Randomized controlled trial|
|Population||Adults (18 years and older) with a clinical diagnosis of stroke or transient ischemic attack who are discharged home from participating hospitals|
Primary: patient-reported functional status
Secondary: caregiver stress, hospital readmission, mortality, continuity of care, use of transitional-care-management billing codes, medication adherence, healthcare use (e.g., emergency department visits, hospital admissions and inpatient days, and admissions to skilled nursing and inpatient rehabilitation facilities), cognitive status, blood pressure management, depression, use of community resources, recurrent stroke, physician follow-up
|3-month follow-up for primary outcome|
Results of This Project
Other Health Services Interventions
Training and Education Interventions
Low Health Literacy/Numeracy