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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Procedures and Evaluation

Map process flow and define the optimal points of care for both the informed consent and decision aid.
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.
Implementation of ePRISM software and the RESOLVE DA.
Monitor proportion of patients in whom the RESOLVE DA is used.
Post-implementation registry or data retrieval of patient/family satisfaction and knowledge, as well as time from presentation to treatment.
Interviews of providers on confidence in making treatment decisions.
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

Patient/family satisfaction.

Time frame: 2 years

Patient/family satisfaction with PRISM for Acute Ischemic Stroke (AIS).
Knowledge transfer.

Time frame: 2 years

Knowledge transfer of AIS and rt-PA risks and benefits through survey.

Sponsors and collaborators

Lead sponsor

Saint Luke's Health System

Other

Collaborators

Genentech, Inc.

Registry information

Official study title

Reperfusion in Acute Stroke - Creating the Clinical Decision-Making Tool (RESOLVE)

Acronym: RESOLVE

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: May 30, 2013
Registry last updated: Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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