Wednesday, April 16, 2008

Dealing with a demand for harmful or ineffective treatments

There is often a lot of commentary about physicians' overuse of medical services, using treatments that are unnecessary or wasteful. But there is also the question of how to handle the situation in which a doctor does not want to deliver a treatment s/he believes would be harmful or ineffective when a patient or a patient's family demands to receive such treatments. Our hospital has a policy on this matter, conceived with broad involvement from our faculty and with particular input from our ethics coordinator. I print it in its entirety below in case it might be useful to other places or informative to this general audience. I think it is pretty self-explanatory, but I am happy to help collect responses to questions in case it is not.

Title: Policy On Treatments That Are Harmful or Ineffective

Purpose: To ensure that medical treatment always respects the dignity and integrity of both the patient and any involved health professionals.

Policy Statement: The goal of medicine is to benefit the patient, and the process of delivering medical care should always respect the dignity and integrity of both the patient and the health care practitioner.

It is the policy of the Beth Israel Deaconess Medical Center that no patient should be forced to undergo, nor should any physician or health professional be forced to provide, a treatment that is ineffective or harmful. A medical treatment is ineffective if there is no reasonable likelihood that it will achieve a medical benefit to the patient. A medical treatment is harmful if the likely suffering or risk of other harm caused by the treatment grossly outweighs any medical benefit to the patient.

In undertaking the care of a patient, a BIDMC physician will offer all available medical treatments that have a reasonable likelihood of benefit without an overwhelming burden of suffering. If a point is reached when no further medical treatment offers any reasonable hope of benefit without an inordinate risk of suffering, the physician will continue to care for the patient, ensuring that any suffering is minimized and the patient’s dignity is respected.

Procedure(s) for Implementation:

Patients, families and providers generally agree in applying these principles of medical care to achieve patient-centered goals. In rare cases, significant disagreements may arise over whether a treatment is ineffective or is harmful. In such circumstances, if all efforts to achieve agreement fail, the following series of steps is recommended, each in a timeframe appropriate to the patient’s clinical situation, and with documentation in the medical record:

  1. The attending physician should seek a formal, independent second opinion from a physician not currently engaged in the patient’s treatment. If the consulting physician concludes that treatment is not ineffective and not harmful, the attending physician may choose to provide that treatment or the consulting physician (or another who is willing to do so) may take over care of the patient.
  1. If the attending and consulting physicians agree that the treatment is ineffective and/or harmful, the patient or family should be offered the opportunity to seek transfer to a facility willing to provide that treatment. The patient or family should be encouraged to seek support and assistance from a BIDMC Patient Relations Representative and/or Social Worker in this and any subsequent steps described below.
3. If the attending physician concludes that these efforts to resolve the disagreement have failed, s/he should notify the administrator on call, who will convene a committee consisting of:
    1. Chief(s) of the relevant medical or surgical service(s) or their designees not involved in the patient’s care
    2. Chair of the Ethics Advisory Committee (EAC) or designee
    3. Representative of the Patient Care Assessment Committee (PCAC)
    4. Senior Vice President of Patient Care Services or designee
    5. Director of Social Work or designee
    6. Director of Pastoral Services or designee
    7. Chief of Psychiatry or designee
    8. Chief Operating Officer or designee
    9. Others deemed appropriate by the committee or its chair

The EAC representative will serve as moderator and chair of the committee. A quorum will consist of a minimum of four members, including at least two physicians, since the committee’s core task is to determine, on medical grounds, whether the treatment under consideration is ineffective or harmful. The quorum must include at least one representative of the relevant medical or surgical service(s), and the representative of PCAC.

The committee will consult with the following parties:

a. The attending physician, who should explain the basis for deeming the treatment to be ineffective and/or harmful. Other members of the treatment team should be asked to add details or to offer different perspectives and interpretations.

b. The patient and/or family spokesperson(s), who should explain the patient’s perspective regarding the treatment under consideration, including hopes or expectations of benefit and views about possible harm(s). A BIDMC Patient Relations Representative and/or Social Worker should be available to the patient and/or family before, during, and after this step.

Following as free an interchange of perspectives as possible, the committee will meet alone to determine whether the treatment is ineffective or harmful.* If the committee does not conclude that the treatment is ineffective or harmful, it may offer suggestions for identifying BIDMC staff that may be willing to assume responsibility for the patient’s care. If the committee does conclude that the treatment is ineffective or harmful, it may offer suggestions to the involved clinical service(s) and BIDMC administration regarding steps that may be taken to ensure that BIDMC staff are not forced to provide the treatment.

One or more representatives of the committee will communicate the committee’s conclusion, any related suggestions, and its reasoning to the concerned parties, with documentation in the medical record.

If the patient or family are not in agreement with a determination by the committee that the treatment is ineffective or harmful, and are unable or unwilling to arrange for transfer to another facility, they should be informed of their options for seeking, within a reasonable timeframe, court involvement. Unless there are legal barriers to doing so, however, BIDMC administration shall take steps to support implementation of the committee's conclusion.

* Finding a treatment ineffective or harmful is a positive finding; in the absence of a clear consensus, the committee should conclude there was inadequate evidence on which to decide that the treatment was ineffective or harmful.


Christian Sinclair said...

This is a pretty sound policy and mirrors many that I have seen. It is important for hospital staff to feel comfortable in saying "No" and knowing the hospital will be able to support them after an appropriate evaluation and process is undertaken.

One thing to note is that these disagreements are between physician and patient/family. What about the nurses or other staff members who actually have to administer the treatment? Is there a way for other staff to raise an objection?

The policy mentions: "nor should any physician or health professional be forced to provide, a treatment that is ineffective or harmful." but in the IMPLEMENTATION section I could not see clearly where a non-physician staff member may enter an objection.

Just wondering if that needs clarification.

Thanks for posting your policy. Yet another demonstration of transparency.

Have you found your ethics consults or activation of this policy has decreased since implementation of an active palliative care team? Some colleagues of mine are looking at how palliative care team growth in hospitals has changed the role for ethics cmtes.

Anonymous said...

Thanks, Christian. I have asked a couple of our folks to respond directly to your questions.

Anonymous said...

Our Palliative Care Service and Ethics Consult Service work very closely together, and I think that has led to them both being very busy. Regarding the issue of non-physician clinicians (such as nurses) ability to activate the "treatments that are harmful or ineffective" that is very much the intent and how the policy has worked in some actual cases; perhaps we need to look at making that even clearer in the policy.
Ken Sands, MD
Senior VP, Health Care Quality

Anonymous said...

I'd be interested in knowing any statistics that might be kept on this policy, e.g.:

* what percentage of patients seek ineffective or harmful care as determined by the treating medical professional?

*of these, how many are moved on to step one of the process (as opposed to merely working it out with their health care professional)?

* how many second opinions come back in conflict with the first? In how many cases does the care move to the health care professional who has deemed the care not ineffective and/or harmful? How many move out of BIDMC all together?

* what percentage of cases ultimately end up at stage three and what are the typical resolutions?

Also, I note that the policy refers to neither patients nor health care professionals being "forced" to do something, but I'd be curious to know how often drugs that a health care professional believes are ineffective are prescribed because a patient wants them due to the happy TV commercials they see and their health care professional rationalizes this by saying to themselves, "it probably won't work but it won't hurt either"?

Lachlan Forrow, MD, FACP said...

Dr. Sinclair is exactly right. In all of our ethics activities (rounds, consultations, other education) we emphasize that NO BIDMC staff member should EVER do anything that s/he thinks is seriously wrong, most of all in the care of a patient. (Minor disagreements within a clinical team about treatments are common and another issue.) This policy is broadly inclusive: “nor should ANY…health professional be forced to provide a treatment that is ineffective or harmful...” If an attending physician has been willing to authorize a treatment, but nurses or others who would administer it believe it is seriously wrong, then nursing and other managers consistently (I hope and believe) support their staff. The Ethics Support Service is available 24/7 as well to reinforce that respect for individual professional conscience is sacrosanct at BIDMC. Sometimes we find another nurse whose professional judgment is different, allowing her or him to participate in the treatment in good conscience. As a practical matter, it is often the perspective of the bedside nurses that leads the attending physician to the conclusion that a treatment is or would be inhumane. But the bottom line for the patient’s care is that the attending physician is ultimately responsible, morally and legally.

Interestingly, in four years we have never had to invoke the last phase of this policy (convening a meeting of clinical chiefs and others to make an institutional determination). When there is family-physician conflict, we regularly seek a second opinion from an independent attending physician, and then perhaps a few times a year invite the family, with help from us, to try to find another facility that would consider the requested treatment(s) appropriate. In my memory finding such a facility and arranging transfer has never happened. In every case so far, family have ultimately accepted our view that “Of course you understand, no one can force a doctor or nurse to do something that s/he thinks is wrong.”

As Dr. Sands points out, another very important and frequent dimension of our care in these cases is involvement of our Palliative Care Service at the earliest possible stage. This team can be enormously helpful to families in understanding that moving to a focus on comfort and dignity is the most caring and loving thing to do. They are involved in several ICU cases every week.

One final and extremely important point is that neither in this policy nor in any other at BIDMC is there any support for making these decisions on the basis of COST. In more than 20 years of work with critically ill patients at our medical center, I have never seen consideration of cost drive any decision, even when there is no insurance to pay for treatment that is hugely expensive, and BIDMC will swallow the expense. Our Finance Department has always unequivocally insisted that this should be true. Yes, even finance people (I sometimes sense that it is especially finance people) would not take any pride in working in an institution where money ever takes precedence over a patient’s life. And professional pride in one’s work is BIDMC’s greatest fuel.

Lachlan Forrow, MD
Director, BIDMC Ethics Support Service
Director, BIDMC Palliative Care Programs

The Happy Hospitalist said...

This is a great policy. However, what kind of legal teeth does it have. I have had futile care in 95 year olds getting trached and vented and PEG'd because, in spite of an ethics committee's recommendation for implementation of comfort care measures, the family refused to accept it. And our hospital legal team made it very clear to us that our state laws would not give us any legal protection should we, as physicians, order the removal of life support and allow a futile care patient the right to die, against the wishes of the POA. It is purely absurd. So while this policy is great in spirit, in practice, I want to know how your hospital would respond in the last stage of your plan. Would you stand by your physicians and support them financially in a lawsuit if they removed care against the will of the family, or would you separate yourselves from the actions of your physicians. Does your state have laws which protect a physician from legal punishment if they remove life support against the wishes of the POA?

Anonymous said...

I think, but I am not sure, that withdrawal of life support without approval of the family, once begun, is a different issue altogether. Perhaps Lachlan or someone else will comment.

However, on the general issue, yes, rest assured that our hospital would stand by any doctor or nurse who followed the policy.

Lachlan Forrow, MD, FACP said...

This policy is intended to establish and support the general principle that no health professional should ever be forced to do something ineffective or harmful, whether that involves life support or not. In practice the intense disputes between (usually) family and physician(s) does involve life support, and the question of whether it should be discontinued in circumstances where the physician(s) (and nurses and others) believe it is inflicting suffering or other burdens that are grossly disproportionate to any medical benefits. As I mentioned in an earlier post, in four years we have not yet needed to implement the phase of convening a hospital committee -- family have always accepted that they cannot force the physician to do something s/he thinks is wrong. We expect that at some point in the future a family will not accept that and then legal adjudication in a court may be necessary. We expect our Legal Department, as stated in the policy, will support our medical staff. We believe that it would be fundamentally wrong for a court to (a) hear the physician say that s/he morally objects to participating in continued life support, and (b) hear that every other physician consulted also morally objects to participating, but then (c) orders a physician to violate his or her personal or professional conscience. We may one day find out.

There is no statute in Massachusetts that provides legal immunity to a physician in this situation. Texas does have such a statute, which allows family a period of time (I think ten days) to find another physician or facility willing to provide the continued life support. If no such physician/facility is found, then the patient's current physician/facility has legal immunity if/when they do discontinue life support. I think that that is a law that other states should replicate.

Lachlan Forrow, MD
Director, Ethics Programs

The Happy Hospitalist said...

Lachlan. Thank you very much for your answer. It is that last stage where all avenues have been exhausted that results in indefinite futile care. As you state, only Texas has protection from going against the wishes of the POA. And no physician is willing to sacrifice their financial well being to get dragged into a lawsuit with irrational POA's. What I commend you in this policy is the lengths your hospital will go to support your physicians if they should ever get to that last step in the process and proceed to withdraw support against the wishes of the POA.