Rapid Evaluation for Stroke Outcomes Using Lytics in Vascular Event (RESOLVE) Registry and Implementation Quality Improvement Study

NCT01864928 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 192

Last updated 2021-10-19

No results posted yet for this study

Summary

Despite abundant evident supporting the use of acute reperfusion therapy in the setting of acute ischemic stroke (AIS), adoption of this practice in routine clinical care is poor. We hypothesize that a significant barrier is the difficulty in weighing the benefits and risks of rt-PA treatment in the care of an individual patient, a problem compounded by the time urgency of decision-making and clinical fears that weigh risks of treatment more heavily than benefits.

The goal of this Quality Improvement (QI) study is to leverage an IT solution that we have developed, ePRISM, that executes multivariable risk models with patient-specific data so that a personalized estimate of an individual's outcomes (both risks and benefits) with and without rt-PA, can be generated so support safer, more effective clinical care. Through an earlier project, we will have programmed ePRISM with the best available risk-stratification models and developed a clinically useful format for presenting the data to support clinical decision-making in AIS.

Through QI, we propose to identify the optimal mechanism for integrating the tool within the routine flow of patient care in preparation for more definitive studies, or dissemination strategies, to improve the treatment of patients with AIS.

Conditions

  • Acute Ischemic Stroke

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY
  • Saint Luke's Health System

    lead OTHER

Principal Investigators

  • John A Spertus, MD, MPH · St. Luke's Hospital, Kansas City, Missouri

  • Carole Decker, MSN, PhD · St. Luke's Hospital, Kansas City, Missouri

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-12-31
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01864928 on ClinicalTrials.gov