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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stroke population

Adults with ischemic stroke.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John A Spertus, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Hospital, Kansas City, Missouri

Carole Decker, MSN, PhD

Role: STUDY_DIRECTOR

St. Luke's Hospital, Kansas City, Missouri

References

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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.

Reference Type DERIVED

PMID: 26515198 (View on PubMed)

Other Identifiers

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ML28677

Identifier Type: -

Identifier Source: org_study_id