Comprehensive Post-Acute Stroke Services

Stroke mortality is 20-40% higher in North Carolina (NC) than in the overall United States.
After discharge, stroke patients are at high risk for complications. Although a model of
stroke post-care (early supported discharge) exists in Europe and Canada, it has not been
adapted for and tested in the US, although patients and stakeholders attest that post-acute
care does not meet their needs. Transitional care services from hospital to home are now
reimbursed by Centers for Medicaid and Medicare Services (CMS), but only for 30 days after
discharge. The study team proposed a pragmatic, cluster randomized trial of 41 NC hospitals
to determine the effectiveness of COMprehensive Post-Acute Stroke Services (COMPASS), a
patient-centered intervention uniting transitional care management services and elements of
early supported discharge in stroke patients discharged directly home.

The study team will build on the successful North Carolina Stroke Care Collaborative (NCSCC)
registry, a prospective stroke database in which 51 (of 113) hospitals in NC enroll patients.
In preparation for COMPASS, the study team engaged these hospitals via webinars. Over 80% of
NCSCC hospitals demonstrated an interest in participation and provided letters of support.

The main question of this pragmatic trial is: Does implementation of COMPASS for all stroke
patients discharged directly home improve functional outcomes as measured by the Stroke
Impact Scale-16 (SIS-16) at 90 days post-stroke? The primary aim is to: compare the COMPASS
model versus usual care on stroke survivors' self-reported functional status at 90 days
post-stroke. The secondary aims are to determine if the COMPASS model affects: (1) caregiver
strain (Modified Caregiver Strain Index); (2) self-reported general health; (3) disability
(Modified Rankin Score); (4) self-reported physical activity; (5) depression (PHQ-2); (6)
cognition (MoCA 5-min protocol); (7) medication adherence (Morisky Green Levine Scale-4); (8)
self-reported falls; (9) self-reported fatigue (PROMIS Fatigue Instrument); (10) satisfaction
with care; (11) secondary prevention - home blood pressure monitoring; (12) self-reported
blood pressure; (13-15) all-cause hospital readmissions at 30-days, at 90-days and at 1 year
after index discharge; (16-17) mortality at 90-days and at 1 year after index discharge;
(18-20) healthcare utilization (emergency department visits, admissions to skilled nursing
facilities/inpatient rehabilitation facilities); and (21) use of transitional care management
billing codes. This study will also evaluate the effectiveness of the COMPASS Intervention in
key patient subgroups based on race, sex, age, diagnosis (stroke versus TIA), stroke
severity, and type of health insurance.

English and Spanish-speaking patients ages 18 and older who are admitted to a participating
hospital with a diagnosis of ischemic or hemorrhagic stroke or transient ischemic attack and
discharged from acute care hospitalization to home will be included (about 6,000
patients/year).

Participating hospitals will be randomized (stratified by stroke volume and primary stroke
center status) to receive COMPASS or usual care (control group) in Phase 1. In Phase 2, usual
care hospitals will cross over to COMPASS, while the early intervention hospitals sustain the
intervention using hospital-based resources.

The trial has three integrated intervention components: (1) COMPASS, which combines
transitional care services provided by advanced practice providers (APPs) and early supported
discharge services coordinated by the Post-Acute Coordinators (PAC); (2) COMPASS-funded
post-acute care coordinators who will engage patient and stakeholder communities to improve
post-acute stroke comprehensive stroke services; and (3) development of a stroke metrics
scorecard for participating sites. Well-trained APPs and coordinators will have access to
online learning and ongoing support/consultation from WFBH personnel and board-certified
vascular neurologists.

The study team will assess 90-day and 1-year outcomes. Outcomes at 90-days will be assessed
by telephone surveyors blinded to patient's group assignment. Patients will be informed about
COMPASS in the hospital and can opt out of 90-day phone follow-up at any time. Those who
agree to be surveyed will be asked to provide informed consent at the 90-day phone call to
collect outcomes data.

This proposal is led by three highly experienced researchers as co-principal investigators.
The team includes expertise in stroke care, large clinical trials, biostatistics, managing
clinical registries, survey and acquisition of patient or proxy-reported outcomes,
community-based practice improvement, building community coalitions to reduce readmissions,
claims analyses, registry management, translating evidence into practice with large
multi-site collaboratives, and engaging patients and stakeholders in research. The planning
phase of this project has been guided by patients and stakeholders. Each community will form
a community resource network to advise and support the implementation of COMPASS, provide
feedback to the team, and help create sustainability. If the COMPASS model shows
effectiveness, engaged patients and stakeholders will be key partners to disseminate and
implement COMPASS throughout the state and beyond.

Inclusion Criteria:

- English and Spanish speaking stroke patients with diagnosis of ischemic stroke,
hemorrhagic stroke or TIA who are discharged home from participating hospitals

- Must be 18 years of age and older at the time of the stroke

Exclusion Criteria:

- Excludes subdural or aneurysmal subarachnoid hemorrhage