Chemotherapy Treatment Consents...What Do You Need?

with Martha Polovich, PhD, RN, AOCN, Associate Director, Clinical Practice

2010-11-18 18:49:47 Marty Polovich Welcome to the ONS Hot Topics Chat.
2010-11-18 18:59:44 Stephanie@ons. Welcome to the ONS Hot Topics chat. Tonight we will be discussing treatment consents with Marty Polovich. Please feel free to ask your questions to Marty. Welcome!
2010-11-18 19:00:03 Marty Polovich Good evening, and welcome to the ONS Hot Topics Chat
2010-11-18 19:00:14 Marty Polovich This is Marty Polovich
2010-11-18 19:00:25 Marty Polovich I will facilitate the discussion
2010-11-18 19:00:37 Marty Polovich I hope that you will participate
2010-11-18 19:00:58 Marty Polovich Informed consent is most often considered a legal issue
2010-11-18 19:01:12 Marty Polovich It is also a patients rights and ethical issue
2010-11-18 19:01:32 Marty Polovich Let me stress that there is often a difference between legal and ethical issues
2010-11-18 19:01:54 Marty Polovich Just because something is legal doesn't make it ethically right, and vice versa
2010-11-18 19:02:24 Marty Polovich Because chemotherapy is given for the treatment of potentially life-threatening illness, it's both
2010-11-18 19:03:00 Marty Polovich Not all settings where chemotherapy is given require a separate consent for chemo
2010-11-18 19:03:12 Marty Polovich Does your setting have a chemo consent?
2010-11-18 19:03:25 Madelinekilby we do
2010-11-18 19:04:20 Marty Polovich OK, many states do not require a separate chemo consent
2010-11-18 19:04:59 Mosera We have separate consents, as well. We are in the process of redesigning both. Other than the ASCO sample Consent to Chemotherapy and Chemotherapy Consent Use and Discussion Guide, do you have any other literary resources you recommend?
2010-11-18 19:05:00 Marty Polovich But ONS and ASCO standards indicate that a consent is a requirement for best practice
2010-11-18 19:05:29 Marty Polovich Those that you mention are some of the best that are "out there"
2010-11-18 19:05:58 Marty Polovich The Chemotherapy SIG virtual community also has some sample consents
2010-11-18 19:06:21 Mosera Excellent! I'll look into that. Thank you!
2010-11-18 19:06:33 Marty Polovich It is important to consult with your Risk Management dept or legal dept. when designing consents
2010-11-18 19:06:46 Marty Polovich They have to be on board before you implement
2010-11-18 19:07:29 Mosera I agree.
2010-11-18 19:07:55 Marty Polovich Lets' talk about what should be in a consent for chemotherapy
2010-11-18 19:08:17 Marty Polovich First of all, it should say more than "consent for chemotherapy."
2010-11-18 19:08:34 Marty Polovich I've seen consents that are not very specific
2010-11-18 19:08:42 Stephanie@ons. Welcome to the chat dcafran!
2010-11-18 19:09:21 Marty Polovich That is really not helpful to patients and provides no documentation of consent
2010-11-18 19:09:39 Marty Polovich Informed consent is really two activities
2010-11-18 19:09:55 Stephanie@ons. Welcome nursg! We are discussing chemotherapy consents.
2010-11-18 19:09:59 Marty Polovich need to comprehend the treatment plan that’s the informed part
2010-11-18 19:10:17 nursg Do you get a different consent each time the agents change?
2010-11-18 19:10:45 Marty Polovich That is the best way to do it--because the patients need to discuss the risks of treatment
2010-11-18 19:10:56 Marty Polovich If that treatment changes, so do the potential risks
2010-11-18 19:11:15 Marty Polovich Patients need to indicate that they agree voluntarily to undergo treatment
2010-11-18 19:11:37 Marty Polovich If that treatment changes, their agreement should also be re-addressed
2010-11-18 19:11:44 Marty Polovich That's the "consent" part
2010-11-18 19:12:19 Marty Polovich People can make informed decisions only if they understand information that will affect their decision
2010-11-18 19:12:32 nursg Our consent is long and states that the treatment may or may not work etc. and the patient does not get a copy and most do not read the three paragraphs. All pts get pt education for each agent prior to treatment.
2010-11-18 19:13:01 Marty Polovich Consents for chemo are necessarily long
2010-11-18 19:13:14 Marty Polovich There is a lot to document
2010-11-18 19:13:32 Marty Polovich The education is an essential part of the consent process.
2010-11-18 19:13:37 nursg Does ONS have a template form that can be used?
2010-11-18 19:14:04 Marty Polovich ONS does not have a consent template, but ASCO does on their website
2010-11-18 19:14:28 nursg I have seen that one.
2010-11-18 19:14:53 Marty Polovich I like the ASCO template because there is also a discussion guide
2010-11-18 19:15:57 Marty Polovich Not all information about treatment needs to be in the consent, but that information that may affect a patient's decision to undergo treatment
2010-11-18 19:16:12 nursg Would it stand up in court?
2010-11-18 19:16:51 Marty Polovich Actually, any consent can be "broken" in court
2010-11-18 19:17:07 Marty Polovich The process is the most important thing
2010-11-18 19:17:13 nursg One more question - there is a place for witness on our form, should it be a family member or a nursing staff along with the physician's signature?
2010-11-18 19:17:58 Marty Polovich A witness can be anyone, but an employee (nurse) is better than a family member.
2010-11-18 19:18:08 Marty Polovich The physician should also sign
2010-11-18 19:18:15 Marty Polovich They are responsible ultimately
2010-11-18 19:19:08 Marty Polovich Risks, benefits, alternatives and voluntariness are the main elements of consent
2010-11-18 19:19:30 Marty Polovich The hard part with cancer treatment is the uncertainty
2010-11-18 19:19:41 Marty Polovich Often treatment does not work
2010-11-18 19:19:55 Marty Polovich Or the side effects vary a lot from patient to patients
2010-11-18 19:20:20 Marty Polovich And patients have a hard time understanding the medical jargon that we often use
2010-11-18 19:21:11 nursg Our physician talks to the patient about the chemo and side effects, we then give written material and give the patient a chance to ask questions, then sign the consent for treatment. These are questions I have had for along time and you have answered them. Thank you.
2010-11-18 19:21:39 mosera Regarding the witnesses, we wonder if we should have at least one witness be a non-employee, in case someone feels that all the witnesses (e.g., nurse and physician) have an conflict of interest. What are your thoughts?
2010-11-18 19:21:41 Marty Polovich Patients also must be told if the treatment is time-sensitive and the consequences of not undergoing treatment
2010-11-18 19:21:59 Marty Polovich Re witnesses
2010-11-18 19:22:13 Marty Polovich The organization should decide who is an appropriate witness
2010-11-18 19:22:31 Marty Polovich But it's often seen as a witness to the signature ONLY , not the consent
2010-11-18 19:22:49 Marty Polovich And a written form is not always done
2010-11-18 19:23:14 Marty Polovich The process is most important--the discussion where the patient is informed, and that the patient agrees to treatment
2010-11-18 19:23:28 Marty Polovich That can be documented in a physician dictated note
2010-11-18 19:23:44 Marty Polovich But, it must include all of the required elements
2010-11-18 19:23:59 Marty Polovich We developed a dictation template for chemo consent
2010-11-18 19:24:18 Marty Polovich When the MD dictates the discussion, it helps them remember to include all the info
2010-11-18 19:25:09 Marty Polovich The Joint Commission lists the elements of consent in their chapter on patients rights
2010-11-18 19:25:47 Marty Polovich We audited charts in our practice for compliance and found that some did really well, and others did not
2010-11-18 19:26:06 Marty Polovich The sites that had a written consent did the best—consistency
2010-11-18 19:26:48 Marty Polovich You also have to consider the literacy of the patients and aim for low reading level
2010-11-18 19:27:06 Marty Polovich Standard approaches require fairly high literacy
2010-11-18 19:27:21 Marty Polovich Written consent forms are usually quite difficult to understand by the non-healthcare professional..
2010-11-18 19:28:05 Marty Polovich They satisfy the legal requirement for consent,
2010-11-18 19:28:21 Marty Polovich they are rarely helpful in explaining the planned treatment or encouraging questions
2010-11-18 19:28:39 Marty Polovich Invite patients to be actively involved in the process
2010-11-18 19:28:48 mosera Do you feel the consent form should address the impact of missed treatments (alluding to no-shows)? I ask because so few of our patients really understand that they may be compromising their outcome if they don't receive treatment due to the fact that they "didn't feel like coming in" several times.
2010-11-18 19:29:38 Marty Polovich I think it is very important to include that information in the discussion. It is difficult to put that into language in a form
2010-11-18 19:30:16 Marty Polovich We're aiming for understanding--and that needs a lot of explanation
2010-11-18 19:30:30 dcafran@optonline.net Should specific side effects be listed or should a consent simply state that written information was given regarding potential side effects?
2010-11-18 19:31:03 Marty Polovich If you have a consent form, it should include specific side effects of treatment
2010-11-18 19:31:19 Marty Polovich Many people have patients sign an education ofrm
2010-11-18 19:31:21 Marty Polovich form
2010-11-18 19:31:25 Marty Polovich That's different
2010-11-18 19:32:23 Marty Polovich That may be appropriate, depending on your setting. If the MD dictates consent, for instance
2010-11-18 19:32:57 Marty Polovich I had a patient with an extravasation injury who said he would not have agreed to treatment if he knew that could happen
2010-11-18 19:33:23 Marty Polovich He had teaching about vesicant extravasation, but it was not documented
2010-11-18 19:33:35 dcafran@optonline.net I can understand that with a vesicant, however if we listed every possible side effect consent would be pages long.
2010-11-18 19:34:01 Marty Polovich So any consent can be problematic "legally"
2010-11-18 19:34:26 dcafran@optonline.net So if it was documented that education was given regarding extravasation that would suffice?
2010-11-18 19:35:00 Marty Polovich In part.
2010-11-18 19:35:21 Marty Polovich You need to decide what is right for your facility and patients
2010-11-18 19:35:40 Marty Polovich There should be documentation somewhere about what the treatment IS
2010-11-18 19:35:47 Marty Polovich The main risks (side effects)
2010-11-18 19:35:55 Marty Polovich And that the patient agrees
2010-11-18 19:36:08 Marty Polovich The level of detail varies a lot,
2010-11-18 19:36:36 Marty Polovich I've seen statements like "The side effects of treatment have been explained to me"
2010-11-18 19:37:28 dcafran@optonline.net Would you consider it acceptable to given written info using a web site like chemocare as I find it uses lay terms for easy understanding. And I will highlight key elements.
2010-11-18 19:37:52 Marty Polovich A little more detail might be helpful, but the process is most important--that the patient indicates understanding and has had an opportunity to have questions answered
2010-11-18 19:38:11 Marty Polovich Chemocare is great for teaching
2010-11-18 19:38:32 Marty Polovich It provides information about treatment in very patient-friendly language
2010-11-18 19:38:51 Marty Polovich Teaching is important when obtaining consent
2010-11-18 19:39:41 Marty Polovich But the consent process is bigger than that--patient has to indicate agreeing to treatment
2010-11-18 19:39:58 Marty Polovich That should be documented somewhere in the record.
2010-11-18 19:40:25 Marty Polovich Don’t' forget that research REQUIRES a signed consent form
2010-11-18 19:40:50 Marty Polovich Nurses play a big role in consent
2010-11-18 19:41:15 Marty Polovich Advocating for patients and their families
2010-11-18 19:41:26 Marty Polovich Experienced oncology nurses know how to do that
2010-11-18 19:41:42 Marty Polovich Nurses work with patients receiving cancer treatment daily
2010-11-18 19:42:16 Marty Polovich Our experience is helpful in providing education and information that can help patients make decisions about their care
2010-11-18 19:42:45 Marty Polovich Nurses can also recognize situations where patients have unrealistic expectations about care
2010-11-18 19:42:57 dcafran@optonline.net Presently, our small hospital uses a pre-op check-list as a consent form and it needs to change...that's my goal here.
2010-11-18 19:43:29 Marty Polovich A pre-op checklist is quite different from pre-chemo
2010-11-18 19:44:17 dcafran@optonline.net Agreed...We do have a particular oncologist who would give a pt chemo in their casket if they consented to it. That's when we've advocated many times...there was no benefit for the pt.
2010-11-18 19:44:47 Marty Polovich That's a difficult situation
2010-11-18 19:45:13 Marty Polovich Only the patient can determine if a benefit is important enough to undergo treatment
2010-11-18 19:45:13 dcafran@optonline.net He just has a difficult time giving up sometimes and has accused us of giving up too quickly.
2010-11-18 19:45:30 Marty Polovich A lot of that has to do with how the treatment is explained to a patient
2010-11-18 19:45:49 Marty Polovich "This will help" is not good enough
2010-11-18 19:46:18 Marty Polovich How the nurse is involve In the informed consent process:
2010-11-18 19:46:32 Marty Polovich Observe and document the informed consent process
2010-11-18 19:46:43 Marty Polovich Provide informed consent document (if there is one)
2010-11-18 19:46:53 Marty Polovich Provide time for the patient to read the form
2010-11-18 19:47:05 Marty Polovich Assess the patient’s understanding of the consent document
2010-11-18 19:47:12 dcafran@optonline.net Would you recommend that the MD has signed consent before starting chemo or it is OK for that to wait?
2010-11-18 19:47:15 Marty Polovich Clarify information
2010-11-18 19:47:33 Marty Polovich Notify the MD if a patient has questions about the treatment
2010-11-18 19:47:46 Marty Polovich Explain procedures and provide education as needed
2010-11-18 19:48:16 Marty Polovich Some nurses obtain verbal assent before each treatment
2010-11-18 19:48:37 Marty Polovich Others figure if the patient "shows up" they consent
2010-11-18 19:48:43 mosera I have the same question as dcafran. Is it okay to have the physician sign the consent after treatment has started, even on a different day than treatment started?
2010-11-18 19:48:53 dcafran@optonline.net So a written consent is not even needed? Or is that by institution?
2010-11-18 19:49:15 Marty Polovich States vary in the legal requirement for chemo consents.
2010-11-18 19:49:30 Marty Polovich Some may use a "consent for treatment"
2010-11-18 19:49:52 Marty Polovich Others may document consent in the record in progress notes
2010-11-18 19:49:59 dcafran@optonline.net Where might we find legal requirements specific to our state?
2010-11-18 19:50:16 Marty Polovich Ask your legal department or Risk Manager
2010-11-18 19:50:36 Marty Polovich Chemo is usually seen differently from surgery
2010-11-18 19:51:41 Marty Polovich We have an ethical responsibility to make sure patients consent to treatment
2010-11-18 19:51:52 dcafran@optonline.net I'm sorry, I was called away before. Where did you say there was a consent template?
2010-11-18 19:52:12 Marty Polovich ASCO website, ONS chemo virtual community
2010-11-18 19:52:38 Marty Polovich I posted a dictation template on the Chemo discussion page, too
2010-11-18 19:53:02 Stephanie@ons. What other questions might you have for Marty as our time is coming to a close?
2010-11-18 19:54:09 Marty Polovich If you have a "good" consent, consider sharing on the Chemo discussion
2010-11-18 19:54:32 dcafran@optonline.net Will do...thanks for the info!
2010-11-18 19:55:02 madeliekilby thank you
2010-11-18 19:55:14 Marty Polovich Your welcome, and good night!
2010-11-18 19:55:18 mosera Thank you, Marty!
2010-11-18 19:55:24 Stephanie@ons. The transcript for the chat will be posted on the ONS website within the next few days.
2010-11-18 19:55:34 Stephanie@ons. Thank you all for joining us.