Outcomes Management for Stroke Patients Using Thrombolytics

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Outcomes-Based Care Delivery

Outcomes Management for Stroke Patients Using Thrombolytics Janice L. Hickman, RN , MSN , CS

Stroke Facts Despite advances in treatment, stroke remains the third leading cause of death in the United States. 8 More than 60% of all stroke survivors live with some type of permanent disability. Of long-term survivors, 15% require institutional care, 25% are dependent on daily living, and 60% have decreased socialization outside of the home. Direct medical costs and loss of employment for stroke victims in the United States approach 30 billion dollars annually. 6 Data from the National Stroke Association screening program indicates that the general public is unaware of the warning signs of stroke, confusing them with symptoms of a heart attack. Only a small percentage of patients/ individuals view stroke as a medical emergency that should be evaluated and treated in a timely manner. This data indicate that there is a need for information and education related to stroke.

New Terminology With recent advances in our understanding of the window of opportunity in new stroke treatment, it is evident that stroke should be treated with the same urgency as heart attacks. A major campaign From the Neuroscience Intensive Care Unit, University Hospitals of Cleveland and Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio

has been underway during the Decade of the Brain to heighten public awareness of stroke as an emergency that must be treated in a timely manner. Brain attack is the new terminology that is offered as a more meaningful tern1 to describe stroke for the public and health care professionals. The term is meant to convey the same sense of urgency as heart attack.

Pathophysiology of Stroke Ischemic stroke results from loss of brain perfusion. The formation of a thrombus in a cerebral vessel narrowed by atherosclerosis or the movement of an embolus from another site in the vascular system to a cerebral artery creates an occlusion of a cerebral artery. The initial injury produced by focal brain ischemia results in a gradation of damage spreading out from a central core. Tissue at the ischemic core the most severely injured area where blood flow i~ most diminished, is permanently damaged within minutes. This central area of densely ischemic tissue is surrounded by the penumbra. The penumbra is the "at risk area of brain cells that are marginally perfused and potentially salvageable.22 If there is no collateral flow and the ischemia in the core of the infarct is dense, the tissue will die within 20 to 60 minutes as blood flow decreases and eventually stops in this area. 5 Available collateral blood supply varies from patient to patient and consequent length of tissue survival from patient to patient. If there is enough

CRITICAL CARE NURSING CLINICS OF NORTH AMERICA I Volume 10 I Number 1 I March 1998

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collateral circulation feeding the penumbra, the brain cells have an opportunity to survive for several hours. The cells in the penumbra will be recruited into the infarcted area if flow is not reestablished to the occluded cerebral artery in a 3 to 6 hour timespan by intervention, spontaneous clot lysis, or increased collateral flow. 23 The term therapeutic window refers to the amount of time that the brain is threatened but can recover. The variables that influence the therapeutic window length are severity of ischemia, degree of collateral circulation, and the amount of time elapsed. 26 Studies indicate that if reperfusion is established to the affected vessel during the therapeutic window the cells of the penumbra may be salvaged. Time is brain is a term that can be used to correlate with the window of opportunity. Early interventions would be expected to lead to clinical improvement before permanent damage and necrosis occur.

New Treatment Options Ischemic stroke can occur with little or no warning, and, when not fatal, may deplete the resources of patient, family, and community. Informed management of hypertension, extracranial vascular disease, and atrial fibrillation can be expected to prevent tens of thousands of ischemic strokes in the United States each year. 6 The majority of ischemic strokes, approximately 80%, result from thrombotic or atherothrombotic processes. This underscores the fact that stroke is a vascular disorder with neurologic consequences and provides a basis for the use of antithrombolytic agents as therapy. The concept of using thrombolytics to treat thrombotic strokes is not new, having first been used in the 1950s. 18 Because of the high incidence of hemorrhage in these trials, thrombolytic therapy has been approached with caution. The success of coronary thrombolysis and the development of modem diagnostic tools such as computed tomography (CD scan and magnetic resonance imaging (MRI), together with a greater understanding of the pathophysiology of brain ischemia, have renewed the interest in thrombolytic therapy for acute ischemic stroke.

Thrombolytic Therapy In order to understand the process of thrombolytic therapy, it is necessary to be familiar with the body's two systems responsible for maintaining vascular integrity: thrombogenesis, and thrombolysis.

Thrombogenesis is a complex process that serves to form clots within the body in response to an insult preventing hemorrhage. In contrast, the purpose of thrombolysis is to lyse or break down clots. Thrombolysis may be achieved by the body's endogenous fibrinolytic system or by introducing exogenous systemic thrombolytic agents. 16 A balance must be kept between the two systems to maintain homeostasis. Clinical Trials

Several exogenous thrombolytic agents have been studied for cerebrovascular use. These agents include fibrinolysis, plasmin, streptokinase, (Kabikinase, streptase) anisoylated plasminogen activator complex (APSAC), urokinase (Abbokinase), prourokinase, and tissue plasminogen activator (tPA), activase, and retavase. At present, activase (tPA) is the only thrombolytic approved by the Federal Drug Administration for intravenous use given in a weight adjusted treatment regimen of 0.9 mg/Kg (maximum dose 90 mg) infused over 60 minutes, with 10% of the total dose given as an initial bolus over 1 minute. The medication must be given in less than the 3 hours of symptom onset of acute ischemic stroke and patients must meet approved criteria before treatment. 7

Clinical Trials of Acute Thrombolysis Three particularly important sets of information exist: 1) early trials, published through 1992, 2) the European Cooperative Acute Stroke Study (ECASS) use of intravenous tissue plasminogen activator within 6 hours of onset, and 3) the National Institutes of Health (NIH) study of intravenous tissue plasminogen activator in the first 3 hours of ischemic deficit. Earlier studies established that use of thrombolyties increased the likelihood of lysing the clot and was often associated with dramatic clinical improvement. 21 Cerebral hemorrhage is a common complication of thrombolytic therapy and the occurrence of bleeding was studied closely in these trials. In the most recently published randomized trials designed to assess the safety and efficacy of thrombolytic therapy in acute ischemic stroke, the Multicentre Acute Stroke Trial-Europe (MAST-E)24 was a double-blind multicenter placebo-controlled trial in which patients with a middle cerebral artery occlusion were randomized to receive streptokinase (1.5 million units over 1 hour) or placebo within 6 hours. The trial was designed for 600 patients but was stopped prematurely because of an excess of severe cerebral bleeding in the thrombolyzed group (156 streptokinase, 154 placebo). 11 However, survivors in the streptokinase group

OUTCOMES MANAGEMENT FOR STROKE PATI ENTS USING THROMBOLYTICS

showed some evidence of a better functional outcome than those in the placebo group, with a trend towards less severe disability on the modified Rankin scale (P = 0.05) and the Barthel score (P = 0.06). Although length of hospitalization was similar in both groups, they had shorter stays in rehabilitation wards or nursing homes (43.2 ± 11.2 days vs 67.4 ± 11.2 days: P = 0.003). 3 Hacke and colleagues 10 published findings from the ECASS study. This was a randomized, placebo controlled study of the safety and efficacy of recombinant tissue plasminogen activator in the setting of acute ischemic stroke. Patients who presented within 6 hours of onset of a stable, moderate to severe hemispheric stroke and who had no or only minor signs of infarction on the initial CT scan were treated with intravenous recombinant tissue plasminogen activator at a dosage level of 1 · 1 mg per Kg. The study included 621 patients randomized from 70 centers in 14 European countries. A total of 109 patients (17.4 percent) were included in the trial despite major protocol violations, so results were reported for both the entire group, termed the "intention to treat" group (including protocol violations) and the "target population" (no protocol violations). 10

Box 1 BARTHEL INDEX2 The Barthel Index scores patients in each of the 10 activities listed below. A score of 10 is assigned for each activity that a patient can perform independently, a score of 5 to each activity a patient can perform with help, and a score of 0 when the patient cannot meet the criteria for performing an activity. The values assigned to each item are based on the time and amount of actual physical assistance required for the individual to perform an activity. 1. Feeding 2. Moving from wheelchair to bed and back (includes sitting in bed) 3. Personal toilet (wash face, comb hair, shave, brush teeth) 4. Getting on and off toilet (handle clothes, wipe, flush) 5. Bathing self 6. Walking on level surface (or if unable to walk, can propel wheelchair; maximum score of 5 here) 7. Ascending and descending stairs 8. Dressing (tie shoes, fasten buttons, do zippers) 9. Controlling bowels 10. Controlling bladder Data from Barthel DW, Mahoney Fl : Functional evaluation : The Barthel index. Maryland State Medical Journal 14:61-65, 1965.

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Box 2 MODIFIED RANKIN SCALE 12 The Modified Rankin Scale is a popular scale used to measure overall functional disability and handicap following stroke. It ranks patients according to six classifications as follows : 0 = No symptoms at all. 1 = No significant disability: patient is able to carry out all previous activities. 2 = Slight disability: patient is unable to carry out all previous activities, but is able to attend to bodily needs without assistance. 3 = Moderate disability: patient requires some help for bodily needs and to walk. 4 = Moderately severe disability: patient requires some assistance for bodily needs and is unable to walk without assistance or physical device. 5 = Severe disability: patient is unable to attend to bodily needs and/or unable to walk without assistance. Data from Italian Acute Stroke Study Group: Hemodilution in acute stroke: Results of the Italian Hemodilution Trial. Lancet 1:318-321, 1988.

The primary end points included general functional outcome measures, the Barthel Index and the modified Rankin Scale, at 3 months, (Boxes 1 and 2). The results demonstrated that there was no benefit from thrombolysis in the intention to treat population, but the target population showed a significant improvement in Rankin Scale results. Specific measures of neurologic function also demonstrated better recovery at 90 days in the target population receiving thrombolysis. In-hospital stay was significantly shorter in both populations with treatment. There was no difference in mortality at 30 days or in the overall incidence of intracerebral hemorrhage among the treatment or placebo groups in either population. However, unlike previous studies, the occurrence of large parenchymal hemorrhage was significantly more frequent, occurring in approximately 190/o of patients treated with rt-PA-'° Another major randomized, placebo controlled trial of intravenous thrombolytic therapy was reported by the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Study group. 25 The NINDS study was conducted as a two part trial; Part 1 (N = 291) tested whether tPA had clinical activity in stroke as indicated by 4 point improvement over baseline values in National Institutes of Health Stroke Scale (NIHSS) 6 or resolution of the neurologic deficit within 24 hours of stroke onset. Part 2 (N = 333) assessed clinical outcome at 3 months. The NINDS study differed from the ECASS report in that a lower dosage of rt-PA was administered (0.9 mg/kg body weight, maximum 90 mg), and the maximum treatment

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time was only 3 hours. Compared with patients given placebo, patients treated with rt-PA were at least 30% more likely to have minimal or no disability at 3 months as measured on the Barthel Index and modified Rankin Scale outcome assessment scales (see Boxes 1 and 2). Although symptomatic hemorrhages occurred more frequently in the treated group, the overall incidence of hemorrhage in both groups was relatively low compared with that reported by ECASS. However, symptomatic intracerebral hemorrhage within 36 hours of the onset of stroke occurred in 6.4% of patients given rt-PA, but in only 0.6% of patients receiving placebo. Also, a significant increase in death from intracerebral hemorrhage occurred in the group treated with rt-PA (6.3% versus 2.4%). 20 These studies indicate that despite the increased frequency of symptomatic hemorrhage associated with thrombolytic therapy, more patients in the treaunent groups were without major disability than in the placebo groups. The risk of intracranial hemorrhage should discourage the indiscriminate use of thrombolytic therapy when clearly defined criteria are not met. 19 These criteria include a well-defined, short interval (less than 3 hours) between the onset of symptoms and the initiation of treatment and the absence of any sign of infarction on the initial CT scan. 21

Outcomes Management of Acute lschemic Stroke Patients Outcomes management provides a framework an institution can build upon to improve patient care . The concept challenges each department to make improvements and work collaboratively to improve patient outcomes. The main factor that contributes to the success of outcomes management is the cooperation among the team and disciplines involved. Both physicians and nurses are searching for better patient outcomes, which include reduced morbidity and mortality rates. Patients and families expect improved health or symptom control from their health care providers. With more studies accumulating evidence of the safety and efficacy of thrombolysis in patients with acute ischemic stroke, the American Heart Association and the American Academy of Neurology together have developed guidelines for treatment of acute ischemic stroke. 20

Current Approach-Brain Attack Pathways Many centers are developing protocols to enhance rapid diagnosis and management of acute

ischemic stroke. Protocols vary with the available resources of each hospital, but there is a growing consensus that in order to have positive o utcomes, thrombolytic therapy for acute ischemic stroke should be readily available. Three key resources are required to achieve this outcome; development of a stroke team with expertise and experience in the diagnosis and management of stroke, 24-hour availability of rapid, highresolution cranial imaging with expert interpretation, and expertise to deal with hemorrhage, including intracranial hemorrhage.26 The success of outcomes management depends on defining and implementing the key elements that will lead to the desired outcomes.

Development of the Stroke Team University Hospitals of Cleveland began a program in late 1993 to encourage immediate intervention for victims of acute ischemic stroke. The goals of the program were to improve the quality of life after strokes with better outcomes and to decrease the length of hospital stay. The Brain Attack Team at University Hospitals consists of health care personnel who work closely with these patients. The core team includes specialists in neurology, neurosurgery, neuroradiology, emergency medicine, the neuro-head nurse, neuro-clinical nurse specialist, and the stroke care coordinator. The team identified key departments that needed to be involved in the development of protocols and pathways to facilitate rapid diagnosis and management of p atients who presented with symptoms of acute ischemic stroke (Figure 1). The biggest challenge for the team was to ensure initiation of the brain attack protocol in a timely manner. The team needed 100% cooperation from all involved departments if the protocol was to achieve positive outcomes. The resources were available . The team now needed to convince these departments that Time is Brain and acute ischemic stroke patients require immediate attention. A Protocol was developed and the key players were identified as well as the roles they would have in the protocol (Figure 2). The stroke team had a meeting with the managers of all departments that would be involved and asked for their cooperation, emphasizing the narrow window of treatment time and the importance of total cooperation of all participating departments if the protocol was to reach the desired outcomes. The team recognized that public awareness of stroke symptoms and knowledge of new treatment modalities were lacking. Emergency medical squads also lacked knowledge about stroke and

OUTCOMES MANAGEMENT FOR STROKE PATIENTS USING THROMBOLYTICS

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Stroke Team EMS

Pharmacy

Emergency Room (Triage)

Radiology

Neurology Neurosurgery Neuroradiology

Laboratory

Rehabilitation Services OT, PT, ST

Nursing

ICU

PR/Community Education

Admitting

Social Work

Administration Figure 1. Key departments that needed to be involved in the development of protocols and pathways to facilitate rapid diagnosis and management of patients who presented with symptoms of acute ischemic stroke.

the importance of rapid transport to the hospital. The team put together a comprehensive educational presentation that was offered at free public seminars in the surrounding areas. EMS squads were given inservices along with ER staff and ICU staff. All presentations emphasized the narrow time window that was allowed and the need for timely intervention in all departments involved if the protocol were to succeed.

Initiation of Thrombolytic Therapy If the clinical presentation, the laboratory data, and the results of cranial CT scan are consistent with the diagnosis of acute ischemic stroke, the indications, contraindications, and relative contraindications for thrombolytic therapy must be considered (Box 3). The American Academy of Neurology, along with the American Heart Association, has provided exclusion criteria that were used as guidelines in our protocol. 21 The neurology resident is responsible for performing history and physical and verifying the time of onset of symptoms and ascertaining that an immediate CT scan is performed and interpreted.

Box 3

EXCLUSION CRITERIA

Absolute contraindications include: • CT or MRI evidence of hemorrhage Relative contraindications include: • CT or MRI evidence of extensive infarction • Age> 80 • GU or GI bleeding in previous 3 weeks • History of CPR, extensive trauma, or surgery within 2 weeks • PT > 15, platelets < 100,000 Clinical considerations influencing the decision about thrombolysis include: • Clinical presentation suggestive of SAH, even if CT negative • Clinical presentation strongly suggestive of hypertensive/diabetic lacunar disease (hypertensive and/or diabetic, age < 65, pure motor hemiplegia, or pure sensory loss) • history of recent seizures • history of suicide gestures/efforts pericarditis, vasculitis, hepatic or renal failure , peritoneal and hemodialysis possible sinus or venous disease, especially in young patients • probable recent cocaine or amphetamine use • complete resolution of symptoms within 30 minutes of onset • obtundation referable to the neurologic deficit mild deficit (NIH SS,,;: 5; not aphasic) From University Hospitals of Cleveland, Stroke Protocol, 1996; with permission.

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ROLE OF "KEY PLAYERS" IN STROKE PROTOCOL EMS • Quick Screen For Stroke •Alert Hospital and BAT Team • Immediate Transport

BRAIN ATTACK PAGE ( Team carries special pagers) * Dispatch Activates BAT (Brain Attack Team) Pagers • Neurology Attending • Neurosurgery Attending • Neurology Resident On-Call • Neurosurgery Resident On-Call • CT Scan Technician • Nursing Supervisor

EMERGENCY ROOM • Immediate Triage upon Arrival to Emergency Room • Establish Time of Onset of Symptoms • Page Neurology Resident On-Call - (Advise patient has arrived) •Lab Work (Stat CBC, Chem 7, Coag Profile, Fibrinogen) •ECG • Start #18 Angiocath • 0 2 I Pulse Oximetry • Alert CT Scan

Figure 2. Protocol that developed and key players identified and their roles.

Informed consent should be obtained whenever feasible. If the patient is aphasic o r confused, consent should be obtained from family members. The patient or family should understand the fact that thrombolytic therapy carries at least a 6.4% risk of intracerebral hemorrhage. 6 Once all initial information is assembled, patients meeting the criteria are placed on the Brain Attack Protocol (Figure 3).

Critical Pathways Several studies have shown that cost and outcomes are improved if patients with cerebrovascular disease are cared for by specially trained physicians at sites with appropriate resources and support personnel. 13 The cerebrovascular service at University Hospitals of Cleveland developed carepaths that direct and coordinate the most appropriate cost effective patient care delivery practices. All stroke patients are placed on a carepath. Ischernic and hemorrhagic stroke patients are graded by the

severity of their deficit, and separate sequences of response and timing are used, as appropriate to the patient deficits. The nursing staff in the neuroICU and neurodivision play an important role in the implementation of the carepath that serves as the nursing care plan for all stroke patients. Stroke carepaths include important guidelines for nursing assessment and interventions, speech, physical, and occupational therapies, social work, and patient education, as well as the scheduling of laboratory tests and special procedures. 13 All brain attack patients are placed on a carepath, even if they do not meet the criteria for thrombolysis. The pathway addresses all aspects of patient care that have been shown to be important for all stroke patients, including discharge planning and desired outcomes (see Figure 1).

Thrombolytic Administration The original University Hospitals study protocol began with use of intravenous and intraarterial uro-

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University Hospitals of Cleveland

Collaborative Problem List:

lschemic Stroke Collaborative Carepath: Inpatient

1. Potential altered mobility 2° to stroke 2. Safety related to altered mobility 3. Potential inability to perform AOL's 2° weakness or sensory deficits 4. Need for education re: signs, symptoms,

Priority 1: ELOS 4 - 6 Days. Minimum to moderate sensory/motor deficits Expected Disposition: Home

Care Coordinator- - - - - - - - - - - - - Focus

Tests, Labs, Procedures

1 - 12 Hours

13 - 24 Hours

Begin Path in ED

Post ED Admit

Date

Date

OActivate BAT Beeper once EMS Ox confirmed and sx w/in 3-6° of onset DMD:Consider exclusion criteria D Head CT w/in 10 mins arrival

OMD:Follow tests ordered w/in 24° of admit : OCXR OMRA OMRI D Trans-Esophageal ECHO OTrans-cranial doppler

STAT LABS (if not completed in ED): OCBC OChem-7 oCXR ocoag-file QFibrinogen baseline OU/AandC&S OMRI Diffusion I Perfusion completed

Stamp Patient Name and Number in Space Above

Day 2 Post Stroke Day__

Date

Post Stroke Day_

Date

Date

Day 5

Day 6

Post Stroke Day_ _

Post Stroke Day_ _

Date

Date

OTrans-Thoracic ECHO if unable to complete TEE initially

1. Onset of Symptoms > 6 hrs ago 2. Dementia requiring custodial care 3. Pregnancy

Contraindications for Brain Attack/Thrombolysis Protocol OCheck ECHO results within 24° of test

OCheck CXR results OFibrinogen levels q12° x 3

Figure 3.

Post Stroke Day_ _

Exclusion Criteria for Brain Attack/Thrombolysis Protocol DEEG if MS change OCarotid Ultrasound if on MRA r/o stenotic disease

012 Lead EKG at 24° post thromboiytic ROUTINE LABS: OChem 14 OESR

OPT/PTI q1 2° x 3

Day4

Day 3

Olnfrared spectroscopy oother studies

Obtain consent for: OAngiography OThrombolysis OAngio completed 012 Lead EKG if not completed in ED

treatment of stroke

OPT,PTI if needed

Absolute contraindications include: 1. CT or MRI evidence of hemorrhage Relative contraindications include: 1. CT or MRI evidence of extensive infarction 2. Age> 80 3. GU or GI bleeding in previous three weeks 4 . History of CPR, extensive trauma or surgery within two weeks 5. PT > 15, platelets < 100,000 Clinical considerations influencing the decision about thrombolysis include: 1. Clinical presentation suggestive of SAH, even if CT negative 2. Clinical presentation strongly suggestive of hypertensive/diabetic lacunar disease (hypertensive and/or diabetic, age 65, pure motor hemiplegia, or pure sensory loss) 3. History of recent seizures 4. History of suicide gestures/efforts 5. Pericarditis, vasculitis, hepatic or renal failure, peritoneal and hemodialysis 6. Possible sinus or venous disease, especially in young patients 7. Probable recent cocaine or amphetamine use 8. Complete resolution of symptoms within 30 minutes of onset 9. Obtundation referable to the neurological deficit

Priority 1 carepath (From University Hospital of Cleveland Stroke Protocol, 1996; with permission).

Illustration continued on following page

1 -12 Hours

13 - 24 Hours

Begin Path in ED

Post ED Admit

Date

Date

Consults

DMD: PT, OT, ST evaluation ordered

Physical Assessment

ORN:Admission assessment completed ORN:Skin integrity assessed ORN:Complete vascular checks per routine if femoral sheath placed ORN:Vital signs completed q _ ORN:Neuro checks completed q_ _

ORN: Assess swallowing OST:Cognitivelinguistic evaluation and swallow test if needed ORN: Continue neuro checks q hour ORN: Assess need for Dobhoff OMD:Remove sheath ORN:Assess femoral site for hematoma/bleed ORN: Vital signs q_ _

Focus

OContinuos EKG monitoring ONIH Stroke Scale completed at admit. NIH =

Day 2 Post Stroke Day__

Day3 Post Stroke Day_

Date

Date OPT and/or DOT and/or OST evaluation completed with recommended plan of care in chart ORN: Neuro checks q shift OAssess need for long-term PEG tube

OVital signs as ordered

ONIH Stroke Scale completed at 24 hrs. Score=

Day4 Post Stroke Day_ _

Date

Days

Day 6

Post Stroke Day_ _

Post Stroke Day_ _

Date

Date

OPT.DOT, OST session(s) as scheduled

OPT.DOT.OST session(s) as scheduled

OPT.DOT.OST session(s) as scheduled

OVital signs q shift

OVital signs q shift

OVital signs q shift

ONIH Stroke Scale completed w/in 24° of discharge

ONIH Stroke Scale completed within 24° of discharge

OPT,DOT.OST sessions(s) as scheduled

OVital signs q shift

ONIH Stroke Scale completed Day 5. NIH= Barthel=

Barthel

Activity

=---

Rankin= OBedrest with head of bed flat to 30°

---

Rankin= OBedrest with HOB flat to 30°

OBedrest with HOB flat to 30° OOOB as ordered

OAssess pt.'s ability to increase activity as tolerated/ordered Olnstruct pt. re: assist needed when OOB

Figure 3 (Continued) .

OBedrest OBedrest with BRP oup with assist OOOB independent

OBedrest OBedrest with BRP OUP with assist OOOB independent

OBedrest OBedrest with BRP oup with assist OOOB independent

Focus

Treatments

1 -12 Hours

13 - 24 Hours

Begin Path in ED

Post ED Admit

Date

Date

OAdmit to NSU/T4 OAdmit to _ _ _ OIVF as ordered OEmbolism precautions as ordered: OTED hose oscD's osafety precautions

0 Foley to CD ORN: IVF's if ordered O Embolism precautions as ordered: OTED Hose osco·s osafety precautions

Day 2 Post Stroke Day__

Date

Date ORN: Assess need for IVF and Foley. o Embolism precautions as ordered: OTED Hose osCD's osafety precautions

Day 4

Day 3 Post Stroke Day_

Post Stroke Day_ _

Date

OTransfer to Tower4 ORN: DC IVF's if not already done OPlace heplock

OMaintain heplock

Continue SCD's if indicated

OD/C SCD's if ambulatory

Day 5

Day 6

Post Stroke Day_ _

Post Stroke Day_ _

Date

Date

Stroke Collaborative Carepath: Inpatient Priority One

Care Coordinator

-~~~~~~~~~~

Focus

Diet

Medications

1 -12 Hours

13 - 24 Hours

Begin Path in ED

Post ED Admit

Date

Date

ONPO upon admission ORN: Assess pt. swallowing ability

ODiet as ordered:

OThrombolytic OResearch protocol OHeparin therapy OASA therapy OTiclid therapy OHydration

ONPO Regular OSoftlPureed o J.Na+J.Chol DADA diet 1800 • 2200

a

ODobhoff tube feeds ocontinue anticoagulation or anti-platelet therapy if ordered OCheck PT/PTT/INR ostart coumadin on Day 1

Day 2

Day3 Post Stroke Day_

Post Stroke Day__

Date

Date OAssess pt.'s ability to tolerate regular diet

Day4 Post Stroke Day_ _

Date

Days

Day 6

Post Stroke Day_ _

Post Stroke Day_ _

Date

Date

OMaintain diet as ordered

OMaintain diet as ordered

OMaintain diet as ordered

OMaintain diet as ordered

ocontinue anticoagulation or antiplatelet therapy if ordered OCheck PT/PTT/INR

ocontinue anticoagulation or antiplatelet therapy if ordered OCheck PT/PTT/INR

ocontinue anticoagulation or antiplatelet therapy if ordered OCheck PT/PTT/INR OResume anti-htn's by time of discharge

ocontinue anticoagulation or antiplatelet therapy if ordered OCheck PT/PTT/INR OResume anti-htn's by time of discharge

OAssess pt.'s Dobhoff tube feeds ocontinue anticoagulation or anti-platelet therapy if ordered OCheck PT/PTT/INR

Figure 3 (Continued).

Focus

Discharge Planning

Intermediate Outcomes

1 -12 Hours

13 - 24 Hours

Begin Path in ED

Post ED Admit

Date

Date

ORN: Give stroke information to patient and family ORN: Consult SW if: 1. Pt. lives alone and has an expected new impairment at discharge 2. No insurance 3. Unusually anxious or depressed pt. or family 4. Other concerns as identified by team

ORN,OMD,OOT, oPT,osw.osT: Start Gold Form if indicated and F/U on MD disposition orders ORN: Contact SW if not already done DMD: Discuss DIC date and probable needs with patient and family

OPt. on Brain Attack protocol w/in 3-6° Of SX ostroke carepath documentation initiated in ED at time of diagnosis ostroke protocol admission orders used OP!. prioritized at time of admission DIV heparin initiated when appropriate 01 °care MD contacted

ostroke scales x3 completed on day of admission OAnticoagulant or anti-platelet agent ordered by Day 1 OMRI ordered OMRA ordered OTEEITTE ordered oswallowing assessed ODiet recommendations ordered based on swallow test results

ORN:Send f/u letter to EMS delivery system re: patient outcomes

Day 2

Day 3 Post Stroke Day_

Post Stroke Day__

Date

Date ORN,OMD,OOT, OPT,OSW,OST: Start Gold Form if indicated and if not already started ORN:Contact Home Care if home care or home rehab needed ORN:Assess pt. transportation needs for D/C and refer to SW if needed ORN,OPT,OOT: Assess need for homegoing equipment and notify SW ORN,OPT,OOT, OST: Begin DIC teaching with pt. and family OSW:Order homegoing equipment as needed OPT/OT/ST eval with recommended plan of care in chart O Dobhoff placed if indicated OHeparin adjusted to obtain therapeutic PTT ocoumadin tx begun osw consult initiated OD/C disposition recommended

ORN,OMD,OOT, OPT,OSW,OST: Complete Gold Form DMD: Write DIC orders and prescriptions ORN,OPT,oOT, OST: D/C teaching Home Care: Confirm home care plan with pt. and family OSW: Arrange transportation if needed OSW: Confirm equipment delivery oPrimary care MD or designated attending MD: Follow patient for therapeutic PT/INR

OSW/RN/MD:Gold Form completed OSNF/Rehab/Home Team confirmed patient disposition OFamily/pt in agreement with plan ocoumadin therapy initiated DMD documents

Figure 3 (Continued).

Day 5

Day 6

Post Stroke Day _ _

Post Stroke Day_ _

Date

Date

Day4 Post Stroke Day_ _

Date OPrepare pt. for discharge to: OHome OTraditional Rehab OSkilled Nursing DMD/RN: If pt. on coumadin, schedule F/U coag study or DMD/RN: If pt. on Ticlid, schedule F/U WBC studies

OHome die with home: ORNOPTOOTOST OHome die with outpatient: OPTOOTOST OSNF confirmed patient acceptance ORehab confirmed patient acceptance OFamily/pt in agreement with plan OHeparin d/c'd 2° therapeutic PTT ocoumadin therapy initiated

Please stamp patient name and number below

Focus

Caregiver Signatures

1 -12 Hours

13 - 24 Hours

Begin Path in ED

Post ED Admit

Date

Date

Day

Day

Day

Day

Day

Eve

Eve

Eve

Eve

Eve

Night

Night

MD:

Day 2

Day3 Post Stroke Day_

Post Stroke Day_

Date

Date

Night

SW:

Night

PT:

Discharge Outcomes

Day4 Post Stroke Day_ _

Date

Day 5

Day 6

Post Stroke Day_ _

Post Stroke Day_ _

Date

Date

Night

OT:

ST:

Date/Signature

1. Appropriate anti-coagulant or anti-platelet therapy initiated. 2.Patient can complete AOL's with minimal assistance. 3.Patient is able to transfer and walk with min assist. 4 .Patient is maintaining adequate nutritional intake. 5.Patient can state the risk factors of CVA and describe the symptoms of a TIA. 6.Patient can explain the use of homegoing medication. 7.NIH, Barthel and Rankin Scales completed within 24° of discharge. 8. Pt. with documented plan for flu of anti-coagulation therapy (PT/INR levels). 9. Pt. has follow-up appt. scheduled at time of discharge.

Figure 3 (Continued).

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kinase (Abbokinase). Treatment was offered if the patient met the criteria. The patient or family member signed consent, with treatment being offered on a compassionate use basis. The time window was less than 6 hours since onset of symptoms. This was based on review of literature of previous research studies. One year after the University Hospitals protocol was in place, a study by Lanzieri et al assessed the clinical efficacy and cost-effectiveness of emergency thrombolysis in stroke patients. 14 The initial neurologic examination was performed using the 42-point (NIHSS)4 (Box 4). This method has been validated and is used widely for stroke trials. 15 A four-point improvement is generally considered to be of significance. 4 More than 60 patients were initially entered into the study protocol, which included only patients with ischemic symptoms referable to the middle cerebral artery, as this is the most common distribution for strokes. Thirty-four patients were proven to have middle cerebral artery thromboembolic disease, and eight were treated according to the protocol guidelines with intra-arterial urokinase. This allowed for comparison of a control group of 26 patients with treated population of eight patients. Changes in the NIHSS between the initial and 24hour evaluations were compared for both groups. Direct and indirect hospital costs along with hospital length of stay (LOS) were also measured for both groups.

Results The average treated patient entered the study with a NIHSS of 15.6 with improvement to 10.5 (P = 0.008) an average improvement of 5.125 points. A four-point improvement on the NIHSS represents a considerable improvement in neurologic status. These results indicated a clinically and statistically significant improvement in the treated population when compared with controls, whose score showed a deterioration in stroke score 8.9 to 9.4 at 24 hours, an average change of -0.5. Importantly, treated patients had one-third risk of being discharged to extended care facilities when compared with their matched controls. The average LOS was 9.5 in the treated population and 10. 75 days in matched controls (NS). Total costs for the initial stay in the treated population averaged $15,202 versus control patients with an average cost of $13,478 (P = 0.65, NS). 14

Ongoing Data- New Treatment Options The results of the NINDS study and FDA approval of intravenous tPA (Activase Alteplase) in the treat-

ment of stroke given within 3 hours of symptom onset prompted University Hospitals Stroke Center to seek approval for t-PA (Activase) use in their study protocol.

University Hospitals' Stroke Protocol Experience Data gathered through Spring of 1997 evaluated 368 patients over 41 months; 78 were treated with t-PA within 6 hours of symptom onset. There were more men than women in the study (men 60%, women 40%), ages ranging from 30-82, with a mean age of 56. The majority of the patients experienced an anterior cerebral territory stroke. Of the entire group, 40% improved by four points on the NIHSS stroke scale in 24 hours, 64% of the patients treated in the first 3 hours improved by four points. Five percent of patients treated w ith thrombolytic agents suffered parencymal hemorrhages during the arterial thrombolytic therapy and 7% had hemorrhages in the first 24 hours. Data are presently being analyzed looking at disposition of patients following stroke treatment with thrombolytics. Options for disposition include home, skilled nursing facilities, rehabilitation centers, or long-term care facilities. Analysis of NIHSS, Rankin, and Barthel scores are also being done. When evaluating outcomes, University Hospitals of Cleveland's first and foremost goal is improvement of clinical outcomes. Although this study involved a relatively small number of patients, the improvement in stroke scores for patients receiving thrombolytics showed the benefit of continuing this protocol.

Future Goals of Stroke Management Studies using thrombolytics in treatment of acute ischemic stroke continue to progress.3 Faster recovery time may shorten hospital stay if treatment is initiated within the window of opportunity. The cost of rehabilitation of stroke patients is in the $30,000 to 50,000 range per patient. If stays can be minimized and physical deficits reduced, the potential for saving millions of dollars per year on stroke recovery is dramatic. This alone is a persuasive argument to continue the study of thrombolytics in acute ischemic stroke. Health care providers should take responsibility for helping to educate the public that there are treatment options for stroke but that they must be administered in a timely manner if we are to achieve positive outcomes for ischemic stroke victims. Brain destruction following an ischemic stroke is gradual and often caused by an intravascular clot. If diagnosed in a timely manner, these clots

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Box 4 NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) 15 The NIHSS is a 42-point scale that quantifies neurologic function in 11 categories, providing a measure of neurologic deficit. NIHSS Assessment Items: 1a. Level of consciousness

0 =Alert 1 = Not alert, arousable 2 =Not alert 3 = Unresponsive 0 = Answers both questions correctly 1b. Level of consciousness questions 1 = Answers one question correctly 2 = Answers neither correctly 0 = Performs both tasks correctly 1c. Level of consciousness commands 1 = Performs one task correctly 2 = Performs neither task 0 =Normal 2. Gaze 1 = Partial gaze palsy 2 = Total gaze paresis 0 = No visual loss 3. Visual fields 1 = Partial hemianopia 2 = Complete hemianopia 3 = Bilateral hemianopia 0 =Normal 4. Facial palsy 1 = Minor paralysis 2 = Partial paralysis 3 = Complete paralysis 0 =No drift 5. Motor arm 1 = Drift before 10 sec 2 = Falls before 10 sec 3 = No effort against gravity 4 = No movement 9 = Amputation , joint fusion O =No drift 6. Motor leg 1 = Drift before 5 sec 2 = Falls before 5 sec 3 = No effort against gravity 4 = No movement 9 = Amputation , joint fusion 0 =Absent 7. Limb ataxia 1 =One limb 2 =Two limbs 9 = Amputation , joint fusion 0 =Normal 8. Sensory 1 = Mild to moderate loss 2 = Severe to total loss O =Normal 9. Language 1 = Mild aphasia 2 = Severe aphasia 3 = Mute or global aphasia O =Normal 10. Dysarthria 1 = Mild to moderate slurring 2 = Severe unintelligible 9 = Intubated or other physical barrier O = Normalphasia 11 . Extinction and inattention 1 = Mildre aphasia 2 =Severe 0 =Normal 12. Distal motor function 1 = Some extension after 5 sec 2 = No voluntary extension after 5 sec Data from Lyden P, Brott T, Tilley B, et al : Improved reliability of the NIH Stroke Scale using video training. Stroke 25 :2220-2226, 1994.

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may be successfully lysed with thrombolytic drugs, thus rescuing otherwise destructed brain tissue. Health care personnel and the general public must learn about this new treatment option and the need to regard stroke as a medical emergency if stroke outcomes are to improve. The Stroke Team at University Hospitals continues to use the stroke pathway protocol as a means of achieving the desired outcomes, with revisions as needed. The stroke team meets monthly, discussing ways to enhance the existing protocol. Public education remains a top priority. Staff nurses

are asked for their input and help fix the glitches in the protocol. Ongoing inservices are conducted when there are changes in the protocol. The core team believes that collaboration among the involved disciplines has played an essential part in the success of this protocol. Administration continues to support the Stroke Protocol because it has proven cost effective and spares treated patients disability and loss of income. As use of this protocol illustrates, quality of care and patient satisfaction can drive us towards goal oriented outcomes.

SUMMARY In the current health care market, there is a sharp awareness by both consumers and managed care providers that hospitals are only as good as the outcomes they can produce. 17 Collaboration among disciplines that provide services, in this case treatment for stroke has enhanced patient outcomes. The synergy that has developed among those involved has thus far created a win-win situation. The key to successful outcomes is to have all those involved possessing a clear picture of their role, accepting it, and taking ownership of it.

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Current advances and treatments. American Heart Association, 1996 Barthel DW, Mahoney FI: Functional evaluation: The Barthel index. Maryland State Medica!Journal 14:6165, 1965 Boisse! JP: Is thrombolytic therapy benefical in acute stroke patients' European Heart Journal 17:17731774, 1996 Brott T, Adams HP, Olinger CP, et al: Measurements of acute cerebral infarction and clinical examination scale. Stroke 20:864- 870, 1989 Camarta PJ, Heras, RC, Latcheau RE: Brain attack: The rational for treating stroke as an emergency. Neurosurgery 34(1): 144-158, 1994 de! Zoppo GJ: Acute stroke-on the threshold of therapy? N Engl J Med 333:1632-1633, 1996 de! Zoppo GJ, Poechk K, Pessin MS, et al: Recombinant tissue plasminogen activator in acute thrombotic and embolic stroke. Ann Neurol 32:78- 86, 1992 Goldstein LB, Matcher DB: Clinical assessment of stroke. JAMA 271 (4):1114-1119, 1996 Hachinski V: Thrombolysis in stroke: Between promise and peril (editorial). JAMA 276:995-996, 1996 Hacke W, Kaste M, Freschi C, et al: Intravenous thrombolysis recombinant tissue plasminogen activator acute hemispheric stroke. The European Cooperative Acute Stroke Study (ECASS). JAMA 274:10171025, 1995 Hommel M, Boisse! JP, Cornus C, et al (for the Study Group): Termination of trial of streptokinase in severe ischemic stroke. Lancet 345:57, 1995 Italian acute stroke study group: Hemodilution in

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acute stroke: Results of the Italian hemodilution trial. Lancet 1:318-321, 1988 Jones KR: Outcomes analysis methods and issues. Nursing Economics 11:145-182, 1993 Lanzieri C, Tarr R, Landis D, et al: Cost-effectiveness of emergency intra-arterial intracerebral thrombolysis: A Pilot Study. AJNRL 16(11):1987-1993 Lyden P, Brott T, Tilley B, et al: Improved reliability of the NIH Stroke Scale using video training. Stroke 25:2220- 2226, 1994 Macabasco A, Hickman J: Thrombolytic therapy for brain attack. ] Neurosci Nurs 27(3):138-151, 1995 Microlo l\1A, Spanier AH: Critical care management in the 1990s: Making collaborative practice work. Crit Care Clin 9:443-452, 1993 Ogler MN, Materson RS, Coplan R: Management of persons with stroke. St. Louis, CV Mosby, 1994, pp 51- 58 Overgaard K: Thrombolytic therapy in experime ntal embolic stroke. Cerebrovascular Brain Metab Rev 6:257-286, 1994 Practice Advisory: Thrombolytic therapy for acute ischemic stroke-summary statement report of the quality standards committees of the American Academy of Neurology. Neurology 47:835- 839, 1996 Selman WR, Tarr R, Landis D: Brain attackemergency treatment of ischemic stroke. J Fam Pract 55(8):2655-2665, 1997 Siejso BK: Pathophysiology and treatment of focal cerebral ischemia, Part I. ] Neurosurg 77:169-184, 1992 Siejso BK: Pathophysiology and treatment of focal

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1059, 1995 26. Wity K, Stein BJ: Ischemic stroke: Today and tomorrow. Crit Care Med 22(6):1278-1289, 1994 Address reprint requests to Janice L. Hickman, RN, MSN, CS 4036 Kenyon Avenue Lorain, OH 44053