s tpa and appropriate documentation for contraindications: a conversation with the joint commission...
TRANSCRIPT
sTPA and Appropriate documentation for
contraindications: A conversation with The Joint Commission and a Physician
Perspective
Shyam Prabhakaran, MD, MS
Rush University Medical Center
11/7/08
s
Source: JAMA, 2000;283:3102-3109 Recommendations for the Establishment of Primary Stroke Centers
Acute Stroke Care • Rapid, accurate
assessment• Imaging protocols• Guideline based order
sets, protocols, and pathways
• Quality and outcome monitoring
sDSC/Stroke-4: Tissue Plasminogen
Activator (t-PA) ConsideredMeasure: All patients who present at a hospital
with symptoms of an ischemic stroke with symptom onset of 3 hours or less should be considered to receive intravenous (IV) t-PA
Rationale: The administration of thrombolytic agents to carefully screened, eligible patients with acute ischemic stroke has been shown to be beneficial in some recent clinical trials. IV t-PA is the only FDA approved treatment for acute ischemic stroke.
sAcute Stroke Evaluation:
60 Minute or Less Protocol• Triage – 10 minutes: Patient compliant, focused history,
vital signs, GCS, ECG• ED Physician – 10 to 20 minutes: Focused history and
physical exam, laboratories, CT Scan-codes stroke (Goal: 25 minute door-to-CT)– Vital sign monitoring, neurologic checks, seizure and aspiration
precautions
• Neurology Consult – 20-30 minutes: Review history, physical exam, review CT Scan
• Treatment Decisions
s
Door to IV TPA Goal < 60 Minutes
=
Time is Brain
• STARS Registry– 38 community, 18 academic hospitals, 389 IV TPA pts– Median door to needle time: 96 minutes
• CDC 4 State Pilot Acute Stroke Registry– 98 hospitals, 6867 acute patients, 118 IV TPA– Treatment within target 60 minutes: 14.4%
Stroke Onset to IV TPA < 3
hours
sDifferential Diagnosis
• Ischemic Stroke• Hemorrhagic Stroke• Trauma• Meningitis/Encephalitis• Mass
– tumor– subdural hematoma
• Seizure: post-ictal
• Metabolic– hyperglycemia– hypoglycemia– post-cardiac arrest– drug overdose
sStrategies in Acute Ischemic Stroke
• Proven– Supportive Care:
– Treat hypoxia
– Maintain normothermia
– Avoid hyperglycemia
– Early parental fluids and permissive hypertension
– Recanalization (Thrombolytics < 3 hours)– Prevent Clot Propagation– Early Implementation of Secondary Prevention
sNIH/NINDS tPA study
Design
Randomized, double-blind placebo-controlled trial
Raters different from baseline examiners
Two parts
Part 1: 24-hour improvement
• Complete resolution of deficit or improvement of 4 points on the NIH stroke scale
Part 2: 3-month outcome
• Consistent and persuasive difference in proportion of patients with minimal or no deficit
sEligibility Criteria
• Ischemic stroke with clearly defined time of onset < 3 hours
• Baseline CT negative for hemorrhage
• Age > 18 years
• Moderate to severe symptoms
sTreatment
Dose 0.9 mg/kg (maximum 90 mg)
10% given as IV bolus
90% constant IV infusion over over 1 hr
Other meds No other anticoagulants or antiplatelet agents for 24 hours post tPA
Strict BP control (< 180/105 mmHg) post-tPA
s• >18 y.o. with ischemic stroke < 3 hours
• Moderate or severe symptoms
• Coagulation status
– If patient has received recent anticoagulation therapy: PT < 15 sec. and normal PTT
– Platelets > 100,000
• Blood Pressure SBP<185mmHg, DBP <110
• Glucose > 50 mg/dl
Thrombolytic Therapy Checklist
Adams HP, et al. ASA Stroke Council. Stroke. 2003;34:1056-1083.
sOther exclusion criteria
• Prior stroke or head trauma within 3 months
• Major surgery within 14 days
• History of ICH or SAH
• GI or GU hemorrhage within 21 days
• Arterial puncture at non-compressible site within 7 days
• Lumbar puncture within 7 days
• Rapidly improving or mild symptoms
• Seizure at stroke onset
• SBP > 185 or DBP > 110
• Glucose <50 or >400 mg/dL
• Any oral anticoagulants
• Elevated PT > 15s or PTT > 1.5x normal
• Platelet count < 100,000
sNINDS TPA Stroke Trial
Global outcome statistic: OR=1.7, 50% v. 38%= 12% benefit
Excellent outcome at 3 months on all scales
52%
38%43%
26%
45%
31%34%
21%
0%
10%
20%
30%
40%
50%
60%
BarthelIndex
RankinScale
GlasgowOutcome
NIHSSscore
TPA
Placebo
s• Benefit at 3 months
– 55% more likely to be neurologically normal
• 12% absolute benefit
• NNT is 8
– 60-70% more likely to have favorable outcome
• Risk of sICH is 6.4%
– Overall benefits include ICHsAdams HP Jr. Stroke 2003;34:1056-1083.
sNumber Needed to Treat to Benefit from IV TPA
Across Full Range of Functional Outcomes
Outcome NNT
Normal/Near Normal 8.3
Improved 3.1
For every 100 patients treated with tPA,
32 benefit, 3 harmed
Stroke 2007; 38:2279-2283
s
• Efficacy similar to NINDS trial
• Rate of ICH: 4%-6%
• Risk of ICH increases with protocol violations– Time >3 hours– Poor blood pressure control– Using prohibited agents– Wrong dose
• 0.9 mg/kg• Maximum dose: 90 mg
– Elevated blood sugar also increases risk
Adams HP, et al. ASA Stroke Council. Stroke. 2003;34:1056-1083.
Use of tPA in Routine Clinical Practice
s• Only 1.8-2.4% of stroke patients review IV tPA• Reasons for exclusions
– Delayed patient arrival (>3 hrs)– In-hospital delays in completion of required tests prior
to rt-PA administration – Presence of exclusion criteria– Physician reluctance to administer the drug due to
inexperience, unavailability of neurological consultation, or fear of medical complications or legal ramifications
s#1 Reason for IV TPA exclusion: Delay to ER 73%
Only 27% of those presenting within 3 hours were treated with IV TPA Of those presenting <3 hours (n=314):1. Rapid improvement 18%2. Mild symptoms 13%3. Protocol exclusion 14%4. Delay in ER 9%5. Comorbidity 8%
Barber PA, et al. Neurology 2001;56:1015-1020.
sRecommendations for appropriate use of tissue
plasminogen activatorKey elements
– Acute stroke teams
– Written care protocols
– Integrated emergency response system and infrastructure for hyperacute evaluation
– Documentation checklist
– Quality improvement programs
JAMA, June 21, 2000-Vol 283, No. 23
sAcute Stroke Team
• Dedicated pager: “Stroke Code”• Arrival at bedside within 15 minutes• Protocols/standing orders in place for all stroke patients:
– Written stroke protocols for IV tPA associated with fewer complications
– Post treatment care pathways (BP control after tPA)
• Stroke team members– Stroke neurologist– Emergency room physician– Residents (if applicable)– Nurses– Radiologist and technicians– Pharmacist
sHospital Logistics
• Neuroradiology– CT available 24 hours a day– Completed within 25 minutes– Read within 45 minutes
• Laboratory services– Results of CBC, BMP, coags back within 45 minutes
• Family, patient, staff, and EMS education• Data collection and performance improvement• Community outreach and education• Institutional support and leadership
sNOTICE: CHANGE IN THE
NEUROLOGY PAGER* 85-7800 is the new pager for Neurology
Use this pager to reach neurology for consults (routine and urgent), for questions to neurology, etc…
85-4500 is now the Acute Stroke Pager
Use this pager for suspected acute stroke (i.e. stroke onset < 12 hours) Use of this pager will activate the acute stroke team
*These changes will be effective on January 2, 2007
Acute Stroke Pager
sRUMC ALGORITHM ACUTE STROKE (ED)
Clinical Suspicion of ACUTE STROKE < 12 Hours from onset
a) New neurological deficit (weakness, numbness, change in vision, change in speech, clumsiness, trouble walking)
ORb) Acute decrease in level of consciousness
ORc) Worst headache of life
Emergency Department
Activate Acute Stroke Pager (85-4500) Notify ED attending Vital signs and finger stick Place 2 large bore peripheral IV’s, NPO Labs (with special label):
- CBC, PT/PTT, - Chem7, troponin
- Type & holdUrine HCG (pre-menopausal women)Notify Radiology technician (26874)STAT Head CT (done w/i 25 min)Neurologic exam/determine onset timeObtain 12-lead ECG, pulse oxGive supplemental O2 for Sp02<93%Obtain chest X-Ray STATAlert pharmacy if tPA eligible
Acute Stroke Team
At bedside within 15 minutes of page.Confirm time of onset (last known normal)Obtain Past Med Hx
- Prior ICH or SAH- Known cerebral AVM, aneurysm, tumor- Recent trauma or surgery- Review current medications
Check vital signs (review BP)Perform NIHSSReview Head CT (read by 45 minutes of arrival)Review available lab tests (gluc, plts, coags)Discuss with Stroke Attending
INITIATE TREATMENT
sAcute stroke labs and CT compliance
0
20
40
60
80
100
Month
Pe
rce
nta
ge
Labs under 45 minutes CT under 25 minutes
Jan Feb Mar Apr May Jun Jul
Stroke lab protocol change 3/17/07
CT protocol change 2/1/07
s
Evaluate AssessmentReview Summary
Reports
Implement Refined ProtocolCoordinate Implementation of
Refined Protocol
Assess Stroke Treatment RatesAnalyze Process from ED to
Discharge, Rates of TPA Use, Other Standards of Care
Refine ProtocolIdentify
Areas for Improvement
s• Goal door-to-treatment time < 60 minutes and
reduce treatment-related complications• Continue to review outcomes following acute
stroke interventions– Monthly meetings– Continue to improve CT and lab times– Chart review for protocol violations and
documentation errors
• Re-educate staff members on protocols– Emails– Staff meeting presentations– In-services
– Stroke champion