Hospitals adopt new protocols for stroke care
From the November ACP Observer, copyright © 2005 by the American College of Physicians.
By Gina Shaw
Neurologists have a saying about stroke patients: "Time lost is brain lost." During an all-too-brief period of only one to three hours after the onset of stroke symptoms, aggressive and appropriate treatments can spare patients' more extensive brain damage and disability.
Neurologists have a saying about stroke patients: 'Time lost is brain lost.'
But for many patients, that window slams shut without intervention. Studies have found, for example, that less than 5% of ischemic stroke patients receive tissue-plasminogen activator (tPA), a powerful thrombolytic approved for treating acute ischemic stroke. And in North Carolina—the heart of the so-called "stroke belt"—a 2003 study found that entire regions of the state lacked either a basic or advanced stroke prevention and treatment center.
That's not unique to North Carolina, said neurologist James C. Grotta, MD, director of the stroke program at the University of Texas Medical School at Houston. "The percentage of patients treated appropriately for acute stroke in the country overall is very small," he said.
Why does stroke remain undertreated? In part, it's a problem of patient education. While patients have been taught to recognize the signs of a heart attack, they're less aware of what a stroke feels like, so don't quickly get medical help.
Stroke, shown here in a colored CT scan. The red area indicates brain tissue affected by an ischemic stroke, which has reduced but not eliminated blood flow.
Undertreatment is also due to hospital and emergency services limitations. Medicare reimbursement has historically been low for stroke care—a factor that may be turning around with new Medicare tPA coverage that took effect last month.
But money is not the only issue. Many emergency physicians and hospital-based internists, who are often the physicians who first see stroke patients, are uncomfortable administering tPA because of the drug's potentially deadly downside of increasing hemorrhage risk. And according to Dr. Grotta, "You can finish an emergency medicine or internal medicine residency without having had any exposure to neurology and without ever having taken care of a stroke patient."
That may be changing. More hospitals are developing protocols that target the use of appropriate therapies and create new staffing and communication models. And a growing trend to certify designated hospitals as stroke centers is another factor working to improve the speed and effectiveness of stroke care.
Reimbursement and certification
Although tPA was first approved in 1996, Medicare didn't change its reimbursement policies for stroke treatment until last month. Hospitals that administer the thrombolytic therapy will receive a base rate of about $6,000 more per stroke case—approximately double the previous reimbursement.
"Before, there was no way to break even on a patient treated with tPA and hospitals ended up losing money," said neurologist Larry B. Goldstein, MD, director of the stroke program at Duke University Medical Center in Durham, N.C., and chair of the stroke council of the American Stroke Association (ASA).
Recommendations for administering tPA are showing up in stroke protocols being increasingly adopted by hospitals. Many protocols are based on recommendations published in 1996 by the ASA, the American Academy of Neurology and the Brain Attack Coalition, a coalition of stroke experts that includes the National Institute of Neurological Disorders and Stroke (NINDS).
Those recommendations are also being used in a new primary stroke center certification program established by the Joint Commission on Accreditation of Healthcare Organizations last year. The program has already certified more than 150 primary stroke centers in 30 states, while states—including New York and Massachusetts—are likewise moving to create designated stroke centers. (See "More hospitals get stroke center designation.")
tPA: raising the comfort level
A central element of acute stroke care, tPA poses significant challenges. The use of tPA increases the chance of converting an ischemic stroke to a bleeding stroke tenfold (from 0.6% to 6%), even when patients with contraindications are excluded. To offer tPA, a hospital must have expert consults and imaging—usually CT scanning—available around the clock to rule out hemorrhagic stroke and other contraindications.
Even with such resources, some emergency physicians remain wary of the drug. "I'm concerned that public expectation is going to be that this has become the standard of care, and it's not," said J. Brian Hancock, MD, immediate past president of the American College of Emergency Physicians and regional vice president of Ohio's Sterling Healthcare, a clinical staffing company that places emergency physicians and intensivists. "It remains controversial in the medical and scientific literature, and I'm concerned the system isn't in place to support widespread use of tPA."
Claiborne Johnston, MD, PhD, director of the stroke service at the University of California, San Francisco, acknowledged these concerns. Typically, he said, two trials are needed to demonstrate a new agent's effectiveness. However, tPA was approved based on only one trial: the NINDS study, with findings published in the Dec. 14, 1995, issue of New England Journal of Medicine.
"That trial demonstrated a very powerful treatment effect," he said. "Findings from European studies are very consistent when you look at the same time range of treatment." A post hoc analysis of the NINDS trial data published in the April 2005 issue of Annals of Emergency Medicine confirmed the earlier findings.
At Valley Medical Center in Renton, Wash., stroke protocols adopted over the past year have changed how tPA is administered—and boosted physicians' comfort level with the therapy. "The decision to treat or not to treat with tPA is completely in the ER," explained Lawrence Dell Isola, MD, Valley Medical's chief hospitalist and a member of the committee that drafted the new protocols. "As hospitalists, we don't actually get called until that treatment decision has been made." (See "Stroke protocol resources.")
The new protocols spell out the diagnostic sequence in which the drug is used. Suspected stroke patients receive a CT scan within 30 minutes of arrival, looking for an intercranial bleed or other tPA contraindications. Most Valley Medical stroke patients also receive a CT angiogram to fine-tune diagnosis.
"A thrombotic stroke doesn't appear on a CT for a couple of days, so usually a diagnosis of stroke is made on physical examination and presenting symptoms," Dr. Dell Isola said. "With the CT angiogram, we can see the thrombus." (According to Dr. Goldstein, CT angiography is not a necessary part of standard tPA treatment recommendations as the test shows only clots in relatively large cerebral arteries.)
In cases of middle cerebral artery or internal carotid artery thrombus, Dr. Dell Isola added, neurosurgeons may be called in to deliver tPA intra-arterially.
"Injecting the drug right into the artery involves much less systemic risk and more effectiveness," he said. "This can be done outside the usual three-hour time frame for tPA, if an interventional neurologist is available." He made it clear, however, that intra-arterial tPA is used only for patients who aren't candidates for intravenous tPA—and only after an appropriate discussion of risks and benefits.
New care models aren't just about tPA, explained the ASA's Dr. Goldstein. "Many other components of the stroke center protocol should lead to improved patient outcomes, whether [patients] receive tPA or not," he said.
At Valley Medical, for instance, other stroke protocol components address blood pressure management, as well as tight glucose control and the use of angiotensin-converting enzyme inhibitors, aspirin and statins.
"Blood pressure management for stroke patients is tricky, because you can cause damage either way," said Dr. Dell Isola. "You don't want to let their blood pressure get too high, but if you bring down their blood pressure too rapidly, you can increase the size of the stroke."
Prior to the new protocols being adopted, he said, caring for stroke patients was frustrating. "You would have people who didn't do anything about blood pressure," he explained. "tPA would be administered based on who happened to be on call. Nothing was formalized, but now we have a rational plan for what we're doing and that makes an enormous difference."
Protocols being adopted also include:
Creating an acute care stroke team. A team does not have to be led by a neurologist or neurosurgeon, but should include personnel with expertise in cerebrovascular disease. At a minimum, a stroke team should include a physician and another health care professional—a nurse, physician assistant or nurse practitioner—who can be available around the clock. A team member should be at the patient's bedside within 15 minutes of being called.
Establishing written care protocols. These should include protocols for the emergency care of patients with ischemic and hemorrhagic stroke, including stabilization of vital functions; initial diagnostic testing, including 24-hour CT scanning and lab service availability; and use of medications, including but not limited to tPA. Studies have shown that clear protocols reduce tPA-related complications and improve stroke care in general.
Directing emergency medical services (EMS). Hospital staff should be able to communicate effectively with EMS personnel while they're transporting a stroke patient—and should have written plans and cooperative educational activities in place.
Creating a stroke unit. European studies show that patients cared for in multidisciplinary stroke units that include rehabilitative services have a 17% lower death rate and a 7% increase in being able to live at home compared to those treated on general wards. Stroke units do not have to be distinct wards but should include expert staff and written care protocols.
Offering neurosurgical services. Not all hospitals have on-site access to a neurosurgeon. But hospitals treating stroke patients should be able to get neurosurgical care for these patients within two hours—either by transfer to another facility or through an on-call neurosurgeon.
Increasing patient awareness
Then there's the X factor: the patient. State-of-the-art protocols will be less effective if people don't dial 911 at the first sign of a stroke.
Dr. Johnston led a study that examined tPA treatment in the San Francisco metropolitan area and found that, much like the national average, only between 4% and 5% of patients got the drug. The researchers then modeled what would happen if tPA candidates who arrived within three hours of the onset of symptoms all received it—and found that treatment rates would go up to only 8%.
"But if everyone called 911 at the moment they had a stroke symptom and was taken to a stroke center, treatment rates would rise to about 50%," said Dr. Grotta. How to make that happen, he said, is the million-dollar question, particularly when public education efforts on stroke awareness haven't to date had much effect.
Meanwhile, Dr. Goldstein said that new interventions on the horizon—including new thrombolytic drugs, endovascular and experimental intra-arterial approaches—make the stroke center concept an idea whose time has come.
"Stroke isn't what it was a decade ago," he said. "Before, we had nothing that had proven efficacy to manage patients with acute stroke." He pointed out, however, that "it does no good to have these new options if you don't have systems in place to be able to implement them safely."
Gina Shaw is a freelance health care writer based in Montclair, N.J.
The information included herein should never be used as a substitute for clinical judgment and does not represent an official position of ACP.
The Brain Attack Coalition's Web site offers practical tools to help hospitals establish guidelines for stroke care, including sample physician checklists, standing order sheets and step-by-step clinical pathways. More information is online.
According to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), a major step forward in providing stroke care is designating certain hospitals as stroke centers.
More and more states seem to agree, with New York, Massachusetts and Florida establishing state stroke-center programs. Emergency responders in those states are required to take stroke patients directly to a state-designated stroke service.
This year, Texas passed legislation establishing a mechanism for identifying regional stroke centers. And "Colorado is also moving in this direction," said neurologist Larry B. Goldstein, MD, chair of the American Stroke Association's stroke council.
Although more stroke centers—both JCAHO-designated and others—are being created, gaps in care still remain. Some experts advocate regional stroke care systems much like the trauma networks that have been set up for victims of violence and accidents.
At the same time, the stroke center model is meeting some resistance. Richard Stennes, MD, a past president of the American College of Emergency Physicians (ACEP), told the Sept. 21, 2005, San Diego Union-Tribune that for every patient who did have a stroke, paramedics might divert as many as 10 patients with migraines, seizures, metabolic problems, drug reactions or hypoglycemia—all conditions with symptoms that can mimic stroke—to stroke center hospitals unnecessarily.
"To the extent that stroke centers help emergency physicians do what needs to be done as part of an overall system approach, that's something we can support," said J. Brian Hancock, MD, ACEP's immediate past president. "But if it's confusing to the public, or if it causes delays in care because people drive further than they should to get to a stroke center, then that could be a problem." According to Dr. Hancock, not every patient who has a stroke needs to go to a stroke center—"and I don't think every hospital needs to be a stroke center."
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