Ischemic Stroke, Stroke
Conditions
Keywords
PROSPER, Stroke, Ischemic Stroke
Brief summary
PROSPER (Patient-centered Research into Outcomes Stroke patients Prefer and Effectiveness Research) is a three year research project to create a national, sustainable model to improve decision-making and patient-centered stroke outcomes through comparative effectiveness research.
Detailed description
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.
Interventions
None listed
Sponsors
Patient-Centered Outcomes Research Institute
American Heart Association
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 6 months after enrollment | Patient Health Questionnaire - 2 Item (PHQ-2) Higher score suggests more depression; range of 0-6. A score of two or higher suggests a diagnosis of major depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Status | 6 months after enrollment | Euro-QOL ver. 5D-3L (EQ 5D-3L) EQ-5D-3L Five level version of the Euro-QOL. Index Value ranging from 0-1.0 Higher scores indicate better functioning |
Countries
United States
Participant flow
Pre-assignment details
Observational survey
Participants by arm
| Arm | Count |
|---|---|
| Ischemic Stroke Patients Patients who have had an ischemic stroke | 1,617 |
| Total | 1,617 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 73 |
Baseline characteristics
| Characteristic | Ischemic Stroke Patients |
|---|---|
| Age, Continuous | 64 years |
| Antidepressant at Discharge Antidepressant - No | 1432 Participants |
| Antidepressant at Discharge Antidepressant - Yes | 185 Participants |
| Race/Ethnicity, Customized race asian | 32 Participants |
| Race/Ethnicity, Customized race black | 227 Participants |
| Race/Ethnicity, Customized race hispanic | 65 Participants |
| Race/Ethnicity, Customized race other/utd | 64 Participants |
| Race/Ethnicity, Customized race white | 1229 Participants |
| Sex: Female, Male Female | 760 Participants |
| Sex: Female, Male Male | 857 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Depression
Patient Health Questionnaire - 2 Item (PHQ-2) Higher score suggests more depression; range of 0-6. A score of two or higher suggests a diagnosis of major depression.
Time frame: 6 months after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ischemic Stroke Patients By Anti-depressant =Yes | Depression | .7 units on a scale | Standard Deviation 0.22 |
| Ischemic Stroke Patients By Anti-depressant =No | Depression | .79 units on a scale | Standard Deviation 0.21 |
Secondary
Functional Status
Euro-QOL ver. 5D-3L (EQ 5D-3L) EQ-5D-3L Five level version of the Euro-QOL. Index Value ranging from 0-1.0 Higher scores indicate better functioning
Time frame: 6 months after enrollment
Population: Comparing functional status of ischemic stroke patients who are and are not taking an antidepressant 6 months post enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ischemic Stroke Patients By Anti-depressant =Yes | Functional Status | 0.77 score on scale |
| Ischemic Stroke Patients By Anti-depressant =No | Functional Status | 0.83 score on scale |