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Patient-centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
American Heart Association
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02146274
First received: May 21, 2014
Last updated: June 23, 2017
Last verified: June 2017
  Purpose
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.

Condition
Stroke Ischemic Stroke

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Observational Study of Patient-centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Home-time (days alive and at home) [ Time Frame: 24 months ]
    Will be analyzed using a linear regression model with transformations as necessary.

  • Quality of Life [ Time Frame: 24 months ]

    Patient reported interviews using validated instruments. The validated instruments that are used will measure:

    Post-stroke fatigue Depression Medication taking behaviors


  • Death [ Time Frame: 24 months ]
    Will be analyzed using the Cox proportional hazard model. Based on the models, the Wald's tests will be used to test the significance of the treatment effects. After fitting models, the marginal residuals from the model will be used to test the goodness-of-fit of the proportional hazards model, with special attention to the proportionality assumption. When this assumption is not supported by the data, possible treatment and time interactions and other possible time-dependent covariates will be used to account for this non-proportionality. The resulting p-values that are less than 5% will be considered evidence of significant marginal differences across the cohorts.


Secondary Outcome Measures:
  • All-cause readmission [ Time Frame: 24 months ]
    Will be analyzed using the Cox proportional hazard model. Based on the models, the Wald's tests will be used to test the significance of the treatment effects. After fitting models, the marginal residuals from the model will be used to test the goodness-of-fit of the proportional hazards model, with special attention to the proportionality assumption. When this assumption is not supported by the data, possible treatment and time interactions and other possible time-dependent covariates will be used to account for this non-proportionality. The resulting p-values that are less than 5% will be considered evidence of significant marginal differences across the cohorts.

  • Stroke/TIA readmission [ Time Frame: 24 months ]
    Will be analyzed using the Cox proportional hazard model. Based on the models, the Wald's tests will be used to test the significance of the treatment effects. After fitting models, the marginal residuals from the model will be used to test the goodness-of-fit of the proportional hazards model, with special attention to the proportionality assumption. When this assumption is not supported by the data, possible treatment and time interactions and other possible time-dependent covariates will be used to account for this non-proportionality. The resulting p-values that are less than 5% will be considered evidence of significant marginal differences across the cohorts.

  • Cardiovascular readmission [ Time Frame: 24 months ]
    Will be analyzed using the Cox proportional hazard model. Based on the models, the Wald's tests will be used to test the significance of the treatment effects. After fitting models, the marginal residuals from the model will be used to test the goodness-of-fit of the proportional hazards model, with special attention to the proportionality assumption. When this assumption is not supported by the data, possible treatment and time interactions and other possible time-dependent covariates will be used to account for this non-proportionality. The resulting p-values that are less than 5% will be considered evidence of significant marginal differences across the cohorts.

  • Bleeding readmission [ Time Frame: 24 months ]
    Will be analyzed using the Cox proportional hazard model. Based on the models, the Wald's tests will be used to test the significance of the treatment effects. After fitting models, the marginal residuals from the model will be used to test the goodness-of-fit of the proportional hazards model, with special attention to the proportionality assumption. When this assumption is not supported by the data, possible treatment and time interactions and other possible time-dependent covariates will be used to account for this non-proportionality. The resulting p-values that are less than 5% will be considered evidence of significant marginal differences across the cohorts.


Enrollment: 1877
Study Start Date: November 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ischemic Stroke Patients
Patients who have had an ischemic stroke that are hospitalized in an acute-care setting.

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Ischemic Stroke patients
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02146274

Locations
United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Patient-Centered Outcomes Research Institute
American Heart Association
Investigators
Principal Investigator: Adrian Hernandez, MD DCRI
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02146274     History of Changes
Other Study ID Numbers: Pro00049705
Study First Received: May 21, 2014
Last Updated: June 23, 2017

Keywords provided by Duke University:
PROSPER
Stroke
Ischemic Stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 28, 2017