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

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ClinicalTrials.gov Identifier: NCT01864928
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : June 21, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
John A. Spertus, MD, MPH, Saint Luke's Health System

Brief 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.


Condition or disease
Acute Ischemic Stroke

Detailed Description:

Specific Aim 1: Implement ePRISM and the RESOLVE Decision Aid (DA) at 2 sites (Saint Luke's Hospital in Kansas City and Saint Luke's North) for Emergency Department (ED) access and decision support.

1. Procedures and Evaluation

  1. Map process flow and define the optimal points of care for both the informed consent and decision aid.
  2. Pre-implementation registry or data retrieval of patient/family satisfaction with information during consent process pre-PRISM, as well as time from presentation to treatment.
  3. Implementation of ePRISM software and the RESOLVE DA.
  4. Monitor proportion of patients in whom the RESOLVE DA is used.
  5. Post-implementation registry or data retrieval of patient/family satisfaction and knowledge, as well as time from presentation to treatment.
  6. Interviews of providers on confidence in making treatment decisions.
  7. Monitor patient outcomes through 90 day follow up phone call as per the standard of care.

Specific Aim 2: Implement ePRISM and the RESOLVE DA onsite at the the Barnes Jewish Hospital Emergency Department. After optimizing the integration of ePRISM and the RESOLVE DA at Saint Luke's Hospital and Saint Luke's North, we will evaluate strategies for implementation at Barnes Jewish Hospital's Emergency Department Telestroke Program.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 192 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Reperfusion in Acute Stroke - Creating the Clinical Decision-Making Tool (RESOLVE)
Study Start Date : July 2013
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Group/Cohort
Stroke population
Adults with ischemic stroke.



Primary Outcome Measures :
  1. Successful implementation of ePRISM and the RESOLVE DA in 3 ED's and a telestroke program. [ Time Frame: 2 years ]
    Successful implementation of ePRISM and the RESOLVE DA in 3 ED's and a telestroke program. Successful implementation is defined as: 1) the activation of ePRISM and generation the RESOLVE DA by ePRISM; 2) the staff and clinician's reported value of the new RESOLVE DA for use during the rt-PA decision making process.


Secondary Outcome Measures :
  1. Patient/family satisfaction. [ Time Frame: 2 years ]
    Patient/family satisfaction with PRISM for Acute Ischemic Stroke (AIS).

  2. Knowledge transfer. [ Time Frame: 2 years ]
    Knowledge transfer of AIS and rt-PA risks and benefits through survey.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients
Criteria

Inclusion Criteria:

  • Acute ischemic stroke
  • 18 years of age or older

Exclusion Criteria:

  • Active internal bleeding
  • History of cerebrovascular accident
  • Evidence of intracranial hemorrhage on pretreatment evaluation
  • Suspicion of subarachnoid hemorrhage on pretreatment evaluation
  • Recent (within 3 months) intracranial or intraspinal surgery, serious head trauma, or previous stroke
  • History of intracranial hemorrhage
  • Uncontrolled hypertension at time of treatment
  • Seizure at the onset of stroke
  • Intracranial neoplasm, arteriovenous malformation, or aneurysm
  • Known bleeding diathesis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864928


Sponsors and Collaborators
Saint Luke's Health System
Genentech, Inc.
Investigators
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Principal Investigator: John A Spertus, MD, MPH Saint Luke's Hospital of Kansas City
Study Director: Carole Decker, MSN, PhD Saint Luke's Hospital of Kansas City

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John A. Spertus, MD, MPH, Daniel J. Lauer MO Endowed Chair; Medical Director CV Outcomes Research, Saint Luke's Health System
ClinicalTrials.gov Identifier: NCT01864928     History of Changes
Other Study ID Numbers: ML28677
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Keywords provided by John A. Spertus, MD, MPH, Saint Luke's Health System:
Acute Ischemic stroke
ePRISM
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases