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TPA and Appropriate documentation for contraindications: A conversation with The Joint Commission and a Physician Perspe

TPA 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. Acute Stroke Care . Rapid, accurate assessment Imaging protocols

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TPA and Appropriate documentation for contraindications: A conversation with The Joint Commission and a Physician Perspe

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  1. TPA 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

  2. Acute Stroke Care • Rapid, accurate assessment • Imaging protocols • Guideline based order sets, protocols, and pathways • Quality and outcome monitoring Source: JAMA, 2000;283:3102-3109 Recommendations for the Establishment of Primary Stroke Centers

  3. Measure: 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. DSC/Stroke-4: Tissue Plasminogen Activator (t-PA) Considered

  4. Acute 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

  5. Time is Brain Stroke Onset to IV TPA < 3 hours = Door to IV TPA Goal < 60 Minutes • 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%

  6. Differential Diagnosis • Ischemic Stroke • Hemorrhagic Stroke • Trauma • Meningitis/Encephalitis • Mass • tumor • subdural hematoma • Seizure: post-ictal • Metabolic • hyperglycemia • hypoglycemia • post-cardiac arrest • drug overdose

  7. CT Results

  8. Strategies 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

  9. NIH/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

  10. Eligibility Criteria • Ischemic stroke with clearly defined time of onset < 3 hours • Baseline CT negative for hemorrhage • Age > 18 years • Moderate to severe symptoms

  11. Treatment 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

  12. Thrombolytic Therapy Checklist • >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 Adams HP, et al. ASA Stroke Council. Stroke. 2003;34:1056-1083.

  13. Other exclusion criteria • 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 • 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

  14. NINDS TPA Stroke Trial Excellent outcome at 3 months on all scales 60% 52% 50% 45% 43% 38% 40% 34% 31% 30% 26% TPA 21% 20% Placebo 10% 0% Barthel Rankin Glasgow NIHSS Index Scale Outcome score Global outcome statistic: OR=1.7, 50% v. 38%= 12% benefit

  15. 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 ICHs Adams HP Jr. Stroke 2003;34:1056-1083.

  16. Number Needed to Treat to Benefit from IV TPA Across Full Range of Functional Outcomes OutcomeNNT Normal/Near Normal 8.3 Improved 3.1 For every 100 patients treated with tPA, 32 benefit, 3 harmed Stroke 2007; 38:2279-2283

  17. Marler JR et al. Neurology 2000;55:1649-55.

  18. Use of tPA in Routine Clinical Practice • 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.

  19. 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

  20. #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.

  21. Recommendations for appropriate use of tissue plasminogen activator Key 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

  22. 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 Acute Stroke Team

  23. 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 Hospital Logistics

  24. Acute Stroke Pager

  25. RUMC 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) OR • b) Acute decrease in level of consciousness • OR • c) Worst headache of life Acute Stroke Team Emergency Department • 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 NIHSS Review Head CT (read by 45 minutes of arrival) Review available lab tests (gluc, plts, coags) Discuss with Stroke Attending 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 & hold Urine HCG (pre-menopausal women) Notify Radiology technician (26874) STAT Head CT (done w/i 25 min) Neurologic exam/determine onset time Obtain 12-lead ECG, pulse ox Give supplemental O2 for Sp02<93% Obtain chest X-Ray STAT Alert pharmacy if tPA eligible INITIATE TREATMENT

  26. Stroke Labs

  27. CT protocol change 2/1/07 Stroke lab protocol change 3/17/07 Jan Feb Mar Apr May Jun Jul

  28. Assess Stroke Treatment Rates Analyze Process from ED to Discharge, Rates of TPA Use, Other Standards of Care Implement Refined Protocol Coordinate Implementation of Refined Protocol Evaluate Assessment Review Summary Reports Refine Protocol Identify Areas for Improvement

  29. 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

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