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

Acute Ischemic Stroke Clinical Trial

— RESOLVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864928
• Other study ID #: ML28677
• Status: Completed
• Start date: July 2013
• Est. completion date: December 31, 2016

Study information

• Verified date: October 2021
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Saint Luke's Health System	Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient/family satisfaction.	Patient/family satisfaction with PRISM for Acute Ischemic Stroke (AIS).	2 years
Secondary	Knowledge transfer.	Knowledge transfer of AIS and rt-PA risks and benefits through survey.	2 years