Patient-centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research

We propose to address existing evidence gaps and develop the requested data on the range of
clinical outcomes that may be experienced by stroke survivors. To achieve these goals, we
will link the nation's largest stroke registry, the American Heart Association (AHA) Get With
The Guidelines-Stroke program and nationwide Medicare claims data, coupled with telephone
interviews for longitudinal treatment and downstream patient-reported outcomes.

Design & Procedures:

Retrospective: Using GWTG-Stroke database and its associated 1900 hospitals, we will conduct
several comparative research protocols prioritized by stroke survivor focus groups and
surveys. GWTG-Stroke registry clinical data linked with Medicare claims will be used for
analysis of effectiveness and safety of post-stroke therapies on long-term clinical outcomes
(n= 450,000). Outcomes of interest include:

"Home-time" (days alive and at home) Death Stroke/TIA readmission All-cause readmission
Cardiovascular readmission Bleeding readmission

Prospective:

We will use the existing AVAIL registry combined with an additional 2000 stroke survivors for
a combined cohort of over 5000 patients to obtain detailed information on patient-reported
outcomes. The AVAIL Registry (IRB # Pro00012243) collected data from 3000 stroke survivors
between 2006 and 2008. We plan to use these data to supplement our prospective PROSPER study.
The PROSPER study will enroll a minimum of 2,000 subjects to augment the data collected from
the AVAIL study. Consented patients from at least 75 sites will complete interviews at 3 and
6 months after discharge. We anticipate that the PROSPER questionnaire will include the
following tools: Fatigue Severity Scale (FSS), Patient Health Questionnaire (PHQ8), modified
Rankin scale (mRS), Barthel Index, EuroQOL (EQ-5D), Stroke-specific quality of life
(SSQOL-12) and Lawton Instrumental Activities of Daily Living (IADL). Sites will consent
interested patients and have them complete a patient contact information form which includes,
name, address, phone numbers, email address, etc. Outcomes of interest include: : Post-stroke
fatigue, Depression, Chronic pain, Medication intolerance, Modified Rankin scale (mRS),
EuroQOL and Stroke-specific quality of life.

Inclusion Criteria:

- Consistent with GWTG inclusion criteria, patients must be older than 18 and have a
primary diagnosis of acute ischemic stroke.

- Ability to give informed consent or the availability of a surrogate who can consent on
the patient's behalf.

Exclusion Criteria:

- Patients with subarachnoid or intracerebral hemorrhage

- Patients with transient ischemic attack (TIA)

- Patients with expected survival less than 6 months/discharged to hospice