Transient Ischemic Attack (TIA) Accelerated Diagnostic Protocol
Costs and Outcomes of an Emergency Department-based Accelerated Diagnostic Protocol vs Hospitalization for Patients With Transient Ischemic Attack: a Randomized Controlled Trial.
1 other identifier
interventional
154
1 country
1
Brief Summary
The primary objective of this study is to determine if emergency department patients with Transient Ischemic Attack (TIA) that are managed using a TIA "accelerated diagnostic protocol", or "ADP", demonstrate a significant decrease in their index visit length of stay and cost, with comparable diagnostic and 90-day clinical outcomes relative to TIA patients randomized to traditional inpatient care. The secondary objectives are to evaluate the potential role of a TIA risk stratification tool and to determine the time to a diagnostic endpoint in both groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2003
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 1, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedMarch 19, 2012
May 1, 2006
May 1, 2006
March 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
length of stay, total costs, and direct costs
Interventions
Eligibility Criteria
You may qualify if:
- Transient ischemic attack confirmed by emergency physician - resolved deficit, not a crescendo TIA.
- Negative HCT
You may not qualify if:
- Positive HCT scan for bleed, mass, acute infarct
- Possible embolic source - A. fib, paroxysmal.A.fib, cardiomyopathy, artificial heart valve, endocarditis, patent foramen ovale, recent MI
- Known carotid stenosis (\>50%) or mural thrombus
- Persistent acute neurological deficits
- Crescendo TIAs
- Non-focal symptoms - ie confusion, weakness, seizure, transient global amnesia
- Hypertensive encephalophy / emergency
- Severe headache or evidence of cranial arteritis
- Fever
- Previous stroke
- Severe dementia
- Nursing home patient
- Social issues that make discharge or follow up unlikely
- Other acute medical problems requiring inpatient admission
- Patient unlikely to survive beyond study follow up period (90 days)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael A Ross, M.D.
William Beaumont Hospital, Wayne State University School of Medicine
- PRINCIPAL INVESTIGATOR
Brian J O'Neil, M.D.
William Beaumont Hospital, Wayne State University School of Medicine
- PRINCIPAL INVESTIGATOR
Philip Kilanowski, M.D.
Corewell Health East
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 1, 2006
First Posted
May 3, 2006
Study Start
August 1, 2003
Study Completion
September 1, 2005
Last Updated
March 19, 2012
Record last verified: 2006-05