Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06270927 |
| Other study ID # |
00003830 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 23, 2023 |
| Est. completion date |
July 10, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
University of Texas at Austin |
| Contact |
Adrienne N Dula, PHD |
| Phone |
5124955922 |
| Email |
adrienne.dula[@]austin.utexas.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to test feasibility of a comparative effectiveness framework for
acute stroke imaging using prospective electronic health data. This is a prospective, cohort
feasibility study of patients presenting to the Emergency Department with suspected acute
ischemic stroke. The clinical stroke team will not be blinded to the imaging modality given
the nature and purpose of the interventions/imaging. Knowledge of the imaging modality used
and the knowledge gained from the resulting data will need to be considered for treatment
decisions. Blinding will be maintained for data abstraction and analyses. Analysis will be on
an "intent-to-scan" basis and all qualifying patients will be included in their assigned
cohort.
Description:
The purpose of this study is to test feasibility of a comparative effectiveness framework for
acute stroke imaging using prospective electronic health data. This is a prospective, cohort
feasibility study of patients presenting to the Emergency Department with suspected acute
ischemic stroke. The clinical stroke team will not be blinded to the imaging modality given
the nature and purpose of the interventions/imaging. Knowledge of the imaging modality used
and the knowledge gained from the resulting data will need to be considered for treatment
decisions. Blinding will be maintained for data abstraction and analyses. Analysis will be on
an "intent-to-scan" basis and all qualifying patients will be included in their assigned
cohort.
All patients will receive standard-of-care therapy and management based on AHA/ASA clinical
practice guidelines. For patients with emergent large vessel occlusions, this will include
adjuvant endovascular therapy if criteria, as stipulated in the guideline, are met. Although
this is referred to as a prospective study, no data collection will occur until after
standard of care procedures.
Population: "Code-Stroke" (potentially-treatable) patients, defined as patients presenting
with clinical syndrome suggestive of stroke within 24-hours of time last known well will be
included.
Setting: four certified stroke centers (Ascension Seton Williamson, Ascension Seton Medical
Center, Ascension Seton Hayes, and Dell Seton Medical Center) Rationale: There is current
equipoise in selection of first scan modality for code stroke. The time-dependent efficacy of
treatment with thrombolytics increases diagnostic burden on the stroke team, particularly
less experienced providers. In efforts to minimize door to needle time (DTN), stroke mimics
may be inadvertently treated with thrombolytics, particularly when insensitive diagnostics
are used. The investigators plan to examine feasibility of comparing CT-first versus MR-first
strategies to guide the development of a future large multicenter comparison.
Methodology: The first-scan imaging modality will be assigned using two different schemes, a)
clustered by hospital site and b) per-patient. Each scheme will be developed by a UT
statistician or study team member, please see details in Randomization Schemes section below.
All practices will follow standard of care methods, no investigational procedures or
interventions will occur as part of this study. A stroke alert is called prior to the arrival
of the patient to the Emergency Department (ED). With this, patient information is
communicated by the Emergency Medical Services team to the care team at the destination
hospital to determine if the patient is potentially treatable (Code-Stroke).
Patient enrollment. Once a Code-Stroke is called, this will establish the patient eligible
for the study and they will be enrolled. All stroke alerts are communicated via text message
to the care team. The charge nurse leads a huddle prior to the arrival of each Code-Stroke
patient. At the time the Code-Stroke is called, the first-scan imaging modality will be
assigned and the patient will be enrolled.
Communication of assigned first-scan modality. The assigned first-scan imaging modality will
be communicated via the ED charge nurse to all members of the care team including attending
physicians, residents, and nursing staff. The mode of communication will be site-specific and
include any of the following: verbal communication at initial pre-arrival stroke-alert
huddle, sign posted at charge nurse desk that can be flipped to either "MRI" or "CT" typed in
large letters, sign at scanners, sign at ED entrance. This will ensure the entire care team
is aware and reminded of the first-scan modality assigned. This procedure was developed in
close collaboration with Emergency Medicine attendings Dr. Steinour, Dr. Vira, and Stroke
Director Dr. Warach along with ED Medical and Nursing Directors at each participating
hospital site.
Randomization Schemes: The prospective study includes two phases in which different
randomization schemes will be evaluated for feasibility. Randomization schemes will be
established a priori by the study Biostatistician. The Phases are as follows:
A) Multi-Center Hospital-Level Cluster Randomization - (Phase A) During the cluster
randomized study period, everyone at the hospital is getting the same standard of care
(diagnostic), the patient is not being randomized. The imaging modality used as first-scan
for code stroke will be the hospital strategy and not determined on a per-patient basis. A
randomization period equal to one-week in which the imaging modality will be either CT or MRI
for all patients at the site. This will be implemented for a study length of 12 weeks. Within
this 12-week period, 4-week blocks will be used to ensure balance in the assignment to either
CT or MRI. Randomization schemes will be independent across the four participating sites.
This cluster randomization is designed to test feasibility of a comparative effectiveness
framework using prospective electronic health data. This study design challenges the
traditional research ethics paradigm. Rather than testing experimental, unproven
interventions, the research question asks how interventions that are widely used compare, and
deploys these interventions in ways consistent with good clinical practice at the hospital
level.
B) Per-Patient Randomization - (Phase B) During the per-patient randomization, the first-scan
imaging modality will be assigned to each eligible patient. A block size of 10 patients will
be implemented to ensure balance in assignment to CT and MRI. The accrual of patients to meet
this 10-patient block will be specific to each hospital site. Randomization will be
independent across sites. The assigned imaging modality will be communicated prior to each
Code-Stroke and posted at the charge nurse station in the ED. With this, the entire stroke
care team will know the assignment for the next Code-Stroke patient prior to their arrival.
