Acute Ischemic StrokeRESOLVENCT01864928
Rapid Evaluation for Stroke Outcomes Using Lytics in Vascular Event (RESOLVE) Registry and Implementation Quality Improvement Study
An observational study of Acute Ischemic Stroke, run by Saint Luke's Health System.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to 31 Dec 2016
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients
Who may be able to join
- Acute ischemic stroke
- 18 years of age or older
Who cannot join
- 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
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- Uncontrolled hypertension at time of treatment
- Seizure at the onset of stroke
- Intracranial neoplasm, arteriovenous malformation, or aneurysm
- Known bleeding diathesis
About this study
Official title: 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.
Read the 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.
- 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.
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic stroke, ePRISM
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke population | Adults with ischemic stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
Patient/family satisfaction.
Patient/family satisfaction with PRISM for Acute Ischemic Stroke (AIS).
Measured: 2 years
Knowledge transfer.
Knowledge transfer of AIS and rt-PA risks and benefits through survey.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startJul 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- John A Spertus, MD, MPH, Principal investigator, St. Luke's Hospital, Kansas City, MissouriCarole Decker, MSN, PhD, Study director, St. Luke's Hospital, Kansas City, Missouri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864928
- Sponsor's protocol ID
- ML28677
- Acronym
- RESOLVE
- Status last verified
- Oct 2021
- First submitted
- 14 May 2013
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26515198
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reperfusion in Acute Stroke - Creating the Clinical Decision-Making Tool (RESOLVE)
- ClinicalTrials.gov ID
- NCT01864928
- Acronym / sponsor ID
- RESOLVE / ML28677
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic stroke, ePRISM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2013
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 30 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke population | – | –Adults with ischemic stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients
Key inclusion criteria (2 listed)
- Acute ischemic stroke
- 18 years of age or older
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Patient/family satisfaction.
Time frame: 2 years
Knowledge transfer.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Derived from this study: PubMed 26515198Decker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Spertus, MD, MPH principal investigator
St. Luke's Hospital, Kansas City, Missouri
Carole Decker, MSN, PhD study director
St. Luke's Hospital, Kansas City, Missouri
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Saint Luke's Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful implementation of ePRISM and the RESOLVE DA in 3 ED's and a telestroke program. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01864928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.