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Patient-Centered Research into Outcomes Stroke patients Prefer and Effectiveness Research (PROSPER)
Investigator (PI): Hernandez, Adrian
Performing Organization (PO): (Current): Duke University, School of Medicine, Department of Medicine, Division of Cardiology / (888) 478-3853
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2013
Final Year: 2019
Record Source/Award ID: PCORI/CE-1304-7073
Funding: Total Award Amount: $2,106,499
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Number of Subjects: 2000
Abstract: Strokes occur when blood vessels to the brain become clogged with either a plaque or by a clot, cutting off blood flow. Approximately 800,000 people in the United States will have a stroke each year and 1/4 will have another stroke. It is the fourth leading cause of death and a leading cause of disability in the United States. Once a patient has a stroke, the major goals are two-fold: recovery and prevention of another stroke or other complications. Common therapies after a stroke include anticoagulants (a blood thinner), statin therapy (cholesterol-lowering), and periodically an anti-depressant. For many, the benefits and risks of these different therapies are unknown especially among stroke survivors 65 years and older, women, and minorities. Anticoagulants come in different forms such as warfarin that requires frequent lab tests and a restricted diet. There are newer anticoagulants without these issues, but there is much less experience with their use. Statin therapy, especially high doses, may have side effects such as muscle aches, and it is unknown whether the benefits seen in younger, healthier patients translate to older stroke survivors. Depression after stroke is common and is associated with higher risk of death. Anti-depressants may improve depressive symptoms, but it is unknown whether it may help stroke survivors live longer with a better quality of life. For all of these therapies, there is wide variation in when and to whom physicians prescribe them. More importantly, the prior studies have not addressed the full range of benefits or harms given the personal characteristics, conditions, and preferences of most stroke survivors. To address these gaps, we will conduct a series of novel comparative effectiveness studies. We will compare the effectiveness and safety of anticoagulation with warfarin versus nothing and compared to novel oral anticoagulants. Similarly, we will compare statin therapy versus nothing and different intensities of statin therapy. Finally, we will evaluate the effectiveness of antidepressant therapy. These studies will use data from the nation's largest clinical registry for stroke (American Heart Association Get With The Guidelines Stroke) linked with Medicare claims for long-term outcomes and with telephone interviews after discharge for patient-reported outcomes (AVAIL Registry). Our stroke survivor focus groups and stakeholders have selected home-time or days alive and well outside an institution as the primary outcome. Other outcomes include recurrent stroke, readmission, survival, functional status, depression, fatigue, and quality of life. To do these observational effectiveness studies, we will use advanced analytic methods including inverse propensity weighting. Results will inform treatment decisions through online tools that present stroke survivors the trade-offs of benefits and risks on a range of outcomes based on their personal preferences, values, and characteristics. More on this project: (1) Ying Xian, Jingjing Wu, Emily C. O'Brien et al. Real World Effectiveness of Warfarin among Ischemic Stroke Patients with Atrial Fibrillation: Observational Analysis from Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) Study. BMJ. 2015 Jul 31;351:h3786. doi: 10.1136/bmj.h3786. (2) Emily C. O'Brien, Melissa A. Greiner, Ying Xian et al. Clinical Effectiveness of Statin Therapy after Ischemic Stroke: Primary Results from the Statin Therapeutic Area of the Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) Study. Circulation. 2015 Oct 13;132(15):1404-13. doi: 10.1161/CIRCULATIONAHA.115.016183. (3) Ying Xian, Emily C. O'Brien, Gregg C. Fonarow et al. Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research: Implementing the Patient-Driven Research Paradigm to Aid Decision Making in Stroke Care. American Heart Journal. 170(1) (July 2015): 36-45. (4) Thomas W. Concannon. Can Patient Centered Outcomes Research Improve Healthcare? BMJ. 2015 Jul 31;351:h3859. doi: 10.1136/bmj.h3859. (5) Hannah D, Lindholm B, Maisch L. Certain uncertainty: life after stroke from the patient's perspective. Circ Cardiovasc Qual Outcomes. 2014 Nov;7(6):968-9. doi: 10.1161/CIRCOUTCOMES.114.001315. Review. PubMed PMID: 25387779. (6) E.C. O'Brien, Y. Xian, G.C. Fonarow, D.M. Olson, L.H. Schwamm, A.F. Hernandez. Clinical commentary on "Certain uncertainty: life after stroke from the patient's perspective". Circulation: Cardiovascular Quality and Outcomes. 2014 Nov;7(6):970. (7) Finding the Keys to a Longer, Better Life after Stroke: a narrative on this project. Patients who have a stroke often receive medications to prevent a recurrence. Researchers are using medical records and new patient-reported data to examine the benefits and risks of these treatments. (8) VIDEO: PROSPER Study for Stroke Survivors and Their Families Dr. Adrian Hernandez talks about the study and its impact on the stroke survivor community.
MeSH Terms:
  • Administration, Oral
  • Aged
  • Anticoagulants /therapeutic use
  • Antidepressive Agents /therapeutic use
  • Comparative Effectiveness Research
  • Data Collection
  • Focus Groups
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors /therapeutic use
  • Insurance Claim Review
  • Medicare
  • Outcome Assessment (Health Care)
  • Patient Participation
  • Patient-Centered Care
  • Quality of Life
  • Registries
  • Stroke /*drug therapy
  • /*prevention & control
  • United States
Country: United States
State: North Carolina
Zip Code: 27710
UI: 20143532
CTgovId: NCT02146274
Project Status: Completed
Record History: ('2018: Project extended to 2019.',) ('2017: Project extended to 2018.',)