Cover This Ground with Patients to Avoid tPA-Related Suits
If you aren't going to give tPA and would like to avoid a lawsuit, you'll want to be very clear in your documentation as to why the patient didn't meet treatment criteria. "And if you do give it, you should be very clear why the patient did meet the criteria," says John Burton, MD, chair of the Department of Emergency Medicine at Carilion Clinic in Roanoke, VA.
Plaintiff attorneys are aware there is a window of opportunity for treatment options for stroke patients. "If a patient presents within that, the failure to provide that treatment is sometimes met with litigation," says Robert B. Takla, MD, MBA, FACEP, chief of the Emergency Center at St. John Hospital and Medical Center in Detroit, MI. "But there are plenty of ways around that litigation. It is an issue of documentation, or lack thereof."
Takla recently was an expert witness in a case where a patient sued because thrombolytics were not given. In this case, he does not believe it was appropriate to treat the patient with thrombolytics.
The patient's National Institutes of Health Stroke Scale (NIHSS) score was two, and symptoms were very minor. "He later had worsening of his symptoms and the stroke score increased, but the allegation was he should have received tPA on presentation, which is incorrect," says Takla.
Some additional documentation would have made it lot easier to defend the case. The ED physician did not document the decision-making process, nor did he provide the option to the patient and his wife, explaining that the NIHSS score was only two, and the risks usually outweigh the benefits of treatment with such minor strokes.
"Then any rational person would decline the tPA, and that should be documented," says Takla. "A lot of times, what ED physicians fail to do well is document the thought process in the medical decision-making portion of the chart. Explaining this in a deposition is much different than explaining it the first time in the chart itself."
In the case of a stroke patient, that includes documenting that you talked with the patient about giving, or not giving, thrombolytics, and whether the patient agreed with your decision.
Patient May Insist
What if you tell the patient, "On your CT scan it looks like you had some bleeding, and because of that it's contraindicated to give tPA," and the patient says, "I don't care, I want it anyway"?
"Document the contraindication," says Matthew Rice, MD, JD, FACEP, an ED physician with Northwest Emergency Physicians of TEAMHealth in Federal Way, WA. "If later there is a complication and the patient is angry, it is clear why you did not give it for medical reasons even though the patient wanted it."
Takla says that one of the first things he tells residents is to involve the patient and family in the decision process for everything, whenever possible. "Our job is to inform. It's not necessarily to decide for. We provide information and recommendations, but it's ultimately the patient's decision," says Takla. "That does not mean you must do what the patient says, you just cannot do something to the patient without their consent, including giving tPA."
Takla says that if he felt tPA was not appropriate, he would explain his reasons to the patient. "They typically make the right decision," he says. "Just document that."
You need to explain the risks that IV tPA carries with it. Takla says that he presents this option to patients with an NIHSS of above four and below 24. After explaining the risks and the benefits, he explains that the patient needs to make the decision right away. He documents that the patient is alert and oriented, capable of making an informed decision, that alternatives have been discussed, and that the patient either decided to proceed or does not want the treatment.
"That's what I document in my chart, and that's how I stay out of court," says Takla.
Though it doesn't happen often, Takla says that occasionally a patient will insist on treatment even if it's contraindicated. "They can insist all they want, but if I feel it's contraindicated it's my obligation to do what I think is best," he says.
In this case, Takla tells the patient, "If you were my family member, I wouldn't make this available to you because it's not appropriate."
Be Clear About Risks
Although some contraindications are absolute, such as evidence of bleeding on the CT scan, active internal bleeding, or history of intracranial hemorrhage or aneurysm, other contraindications are not as clear-cut. The patient may have had major surgery two-and-a-half weeks ago, a myocardial infarction a few months ago, a seizure with the stroke, or a spinal tap within a week.
The chart always should reflect the appropriate care that's been rendered to the patient, and the rationale behind it. "If you do the right thing, it also serves secondarily as a medical legal document. But the intent is to document the facts. Hopefully from that, your thought process and logic comes through," says Takla.
Correcting a patient's unrealistic expectations for tPA could avoid a later lawsuit.
"Patients may believe that it will just bring them back to normal again," says Hartmut Gross, MD, a professor of emergency medicine at Medical College of Georgia in Augusta. "You need to explain that the goal is to alleviate or minimize some of the stroke symptoms, but there is a possibility that this is not going to happen. Also, there is a risk of intracranial hemorrhage and other bleeding complications and death. Nobody wants to hear that, but everybody has to hear that. And make sure that is documented."
Gross says that it's not enough to simply give the patient his or her options. "There is no way they can properly process all that and come to an informed decision. A lot of times they will look to the physician and ask, 'Well, what do you recommend?' I say here's what I have to offer and the risks that come along with that, these would be my recommendations unless you have a disagreement.' That shifts that burden over to me, which I think is where it should be," Gross says.
Document your informed consent discussion with the patient, if he or she is able to participate, and with family or other legal representatives.
"Be very clear about the risks, benefits, and alternatives to proposed tPA therapy," says Victoria L. Vance, JD, a health care attorney with Tucker, Ellis & West in Cleveland, OH. "It is not a guarantee of success, and is not for every patient, regardless of what the television medical shows portray."
Sources
For more information, contact:
John Burton, MD, Chair, Department of Emergency Medicine, Carilion Clinic, 1906 Belleview Avenue, Roanoke, VA 24014. Phone: (540) 266-6331. E-mail: [email protected].
Hartmut Gross, MD, Department of Emergency Medicine, Medical College of Georgia, Augusta. Phone: (706) 721-7144. E-mail: [email protected]
Matthew Rice, MD, JD, FACEP, Northwest Emergency Physicians of TEAMHealth, 505 S. 336th Street, Suite 600, Federal Way, WA 98003. Phone: (253) 838-6180, ext. 2118. Fax: (253) 838-6418. E-mail: [email protected]
Robert B. Takla, MD, MDA, FACEP, Chief, Emergency Center, St. John Hospital and Medical Center, 22101 Moross, Detroit, MI 48236. Phone: (313) 343-7071. E-mail: [email protected].
Victoria L. Vance, Tucker Ellis & West LLP, Cleveland, OH. Phone: (216) 696.3360. Fax: (216) 592.5009. E-mail: [email protected].
Jamison G. White, Silverman, Thompson, Slutkin & White, 201 N. Charles St., Suite 2600, Baltimore, Maryland 21201. Phone: (410) 385-9104. Fax: (410) 547-2432. E-mail: [email protected].
If you aren't going to give tPA and would like to avoid a lawsuit, you'll want to be very clear in your documentation as to why the patient didn't meet treatment criteria. "And if you do give it, you should be very clear why the patient did meet the criteria," says John Burton, MD, chair of the Department of Emergency Medicine at Carilion Clinic in Roanoke, VA.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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