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

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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 192

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Stroke population; Adults with ischemic stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful implementation of ePRISM and the RESOLVE DA in 3 ED's and a telestroke program.	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient/family satisfaction.	Patient/family satisfaction with PRISM for Acute Ischemic Stroke (AIS).	2 years
Knowledge transfer.	Knowledge transfer of AIS and rt-PA risks and benefits through survey.	2 years

Collaborators and Investigators

• Sponsor: Saint Luke's Health System
• Collaborators: Genentech, Inc.
• Investigators: Study Director: Carole Decker, MSN, PhD, Saint Luke's Hospital of Kansas City

Publications and helpful links

General Publications

• Decker C, Chhatriwalla E, Gialde E, Garavalia B, Summers D, Quinlan ME, Cheng E, Rymer M, Saver JL, Chen E, Kent DM, Spertus JA. Patient-Centered Decision Support in Acute Ischemic Stroke: Qualitative Study of Patients' and Providers' Perspectives. Circ Cardiovasc Qual Outcomes. 2015 Oct;8(6 Suppl 3):S109-16. doi: 10.1161/CIRCOUTCOMES.115.002003.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ACTUAL): December 31, 2016

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (ESTIMATE): May 30, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Acute Ischemic stroke; ePRISM
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: ML28677