Artificial Enteral Nutrition & Time-limited Trials

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A targeted presentation looking at the literature on enteral nutrition. Seeks to expand the thinking of medical providers when a patient is having difficulty swallowing at the end of their life. …

A targeted presentation looking at the literature on enteral nutrition. Seeks to expand the thinking of medical providers when a patient is having difficulty swallowing at the end of their life. Describes the situations in which artificial nutrition is medically inappropriate.

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  • This series is designed to:
    Encapsulate a common problem in those with life-threatening illness
    Challenge your perspective on a common intervention
    Broaden your thinking surrounding goals of care

    Problem: patient can’t or won’t eat
    Likely: aspiration, inanition; death
    Options: DESTINATION THERAPY (vs. bridging therapy) WITH…NPO; NG; percutaneous FT; TPN; comfort feeding
    Benefits & Burdens: TBD

    Image: https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&docid=0h9HQsxTfnUmeM&tbnid=08TATVPZj4LO0M:&ved=0CAUQjRw&url=http%3A%2F%2Fhawaiiesquire.wordpress.com%2F2012%2F05%2F29%2Fdraw-the-law-informed-consent-form%2F&ei=qLFAUvatKOWEjAKfq4HAAg&bvm=bv.52434380,d.cGE&psig=AFQjCNGb1X_8Zffy7OokQKEVEqzjuIzdoQ&ust=1380057836904675
  • There is no ethical differentiation between withholding and withdrawing therapy even though the two may feel quite different
    The principle of autonomy affords patients (and their surrogates, when appropriate) the right to refuse medical care even if that decision may, in the opinion of the treating team, hasten their death.
    It is the duty of the team to balance risk and harm with respect to medical interventions
    Avoid interventions that will bring undue morbidity and mortality.
    WE SHOULD BE IN SUPPORT OF PATIENT/FAMILY DECISIONS, AND LEAD, BUT NOT FORCE
    It is ethical to withhold or withdraw nutrition and hydration for the patient who lacks decision-making capacity after discussion with the appropriate proxy.

    Informed Consent
    Be prepared to discuss
    The problem
    What is involved
    What is likely to happen
    The benefits & burdens

    AMA Code of Medical Ethics. Opinion 2.20: Withholding or withdrawing life-sustaining treatment. American Medical Association. Updated 1996.

    Image: https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&docid=P3Tw6PR-lZ6vfM&tbnid=xNoVog2wROKZKM:&ved=0CAUQjRw&url=http%3A%2F%2Fngcsucounselingethics.wikispaces.com%2FRelevant%2BEthical%2BCodes%2Band%2BConsiderations&ei=WqlAUqHkNcPCigKVq4DwAQ&bvm=bv.52617933,d.cGE&psig=AFQjCNHNs15vFoS4R_slsxzKDdVWt8Wnpg&ust=1380055759878909
  • All states in the United States have statutes covering issues related to withholding or withdrawing life-sustaining treatments
    The Quinlan case (1976) established that artificial nutrition could be withdrawn even from a patient in a persistent vegetative state
    In 1983, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research found that no treatments, including artificial nutrition and hydrations, were obligatory
    This was confirmed in the United States Supreme Court decision on the Cruzan case (1990) which established that artificial hydration and nutrition are like other life-sustaining treatment
    It was upheld again in Florida courts in the case of Schiavo (2005)
    It is a duty of the clinician to be aware of relevant institutional policy, law and statute for their area of practice.


    Image: https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&docid=u1hdE9LE6IrdBM&tbnid=Q10i-eWHG0meaM:&ved=0CAUQjRw&url=http%3A%2F%2Fwww.nursingcareersaustralia.com%2Fnursing-careers%2Fwhat-makes-us-different%2Fethical-recruiting-practices%2F&ei=g6lAUqGFJoGjigKIs4HQBw&bvm=bv.52617933,d.cGE&psig=AFQjCNHNs15vFoS4R_slsxzKDdVWt8Wnpg&ust=1380055759878909
  • FAST 7D: can no longer dress or bathe self; loss of continence; single word; cannot walk or sit up without assistance.
  • 25% of the rest change their minds when they hear the details.


    So what do we get from feeding tubes…?

    Image credit: http://news.brown.edu/files/article_images/intubation1.jpg
  • NEJM article on outcomes in advanced dementia from 2009.
  • Sentinel events rarely precipitated death — only seven events occurred during the last 3 months of life among residents who died: two strokes, two seizures, one hip fracture, one episode of gastrointestinal bleeding, and one myocardial infarction.
  • Nausea with PO food or fluid
    Most experts feel that dehydration in the last hours of living does not cause distress and may stimulate endorphin release that promotes the patient’s sense of well-being
    Loss of sphincter control is distressing to all involve and threatens skin integrity
  • Patients, family, and some clinicians erroneously believe that the patient is weak because he or she is not eating
    They erroneously attribute not eating as the reason for decline or death
    There are reasons to believe that the patient with anorexia associated with advanced cancer or dementia is not suffering because of it
    In most cases, it is the meaning of not eating which distresses patients and families; finding meaning is an emotional and spiritual, not a biological, issue

    Image: https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&docid=-J8TURYb7rMSZM&tbnid=eaX3Cn7smOZppM:&ved=0CAUQjRw&url=http%3A%2F%2Fwww.bpc.edu%2Fnews_and_info%2Fnews%2F2006%2F2006-08-aug%2F08-04_bpc_liberty_campus_block_party.html&ei=PqtAUozlCuH8iwK74YCYAQ&psig=AFQjCNG387qce5xyAPIlUEEXIpApHAukWw&ust=1380056209481441
  • Amount of control afforded to providers differs based upon how moral the decision seems to patients
    Demonstrates that therapeutic paternalism has a limit with regard to what are considered highly moral choices.
    Also indicates a need for providers to frame options in a proper light (medical vs. moral)
    limit choices proactively to those that are medically reasonable.
    “Life-sustaining/supporting” vs. “death-prolonging”
    I.E. when the long-term family caregivers of patients are asked about…“The term ‘life-sustaining treatment measures’ was often interpreted differently than how it would be defined medically. ANH or administration of antibiotics was not seen as a medical but ‘normal’ or ‘basic’ treatment by the family caregivers in this study.” (Kuehlmeyer et al., 2012.)
  • Make sure that family members and caregivers know that artificial fluids and nutrition may make edema, ascites, pulmonary and other secretions, and dyspnea worse
    Ensure that family and caregivers know that a state of dehydration in a patient who is bed-bound and imminently dying may have some benefits
    Pulmonary secretions, vomit­ing, and urinary incontinence may be less
    Dehydration may actually stimulate the production of endorphins and other anesthetic compounds that help to contribute to a peaceful, comfortable death for many patients
    Both high-volume infusions and excessive urination may be a source of discomfort to the patient

    Image: http://www.google.com/url?sa=i&source=images&cd=&cad=rja&docid=v8WxncypcHmziM&tbnid=PAh8rcBHSUDIoM:&ved=0CAgQjRwwAA&url=http%3A%2F%2Ftgenp.pointclick.net%2FHomepage%2Ftabid%2F36%2FarticleType%2FArchiveView%2Fmonth%2F5%2Fyear%2F2009%2FDefault.aspx&ei=36pAUtLUJcSYiAKl5oGIAg&psig=AFQjCNGrivoTVwOWiv3TSQ-OTTfKryz61Q&ust=1380056159671255

  • The use of feeding tubes is associated with higher mortality than those not RECEIVING ONE (78% of end-stage dementia patients die within three months following placement of a feeding tube)

    JAMA: in peds and animal models, PEG tubes lower LES tone; tubes are an independent risk factor for Asp PNA; a nonrandomized, prospective study demonstrated high rates of death from PNA in pts with PEGs. (Fincucane et al. 1999.)

    Of patients with feeding tubes:
    29% required chemical restraint
    26% required physical restraint
    14% reported that there was no discussion prior to placing tube (Teno, 2011.)

    Image: https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&docid=uOWTC_bHNS3pBM&tbnid=ttyZAzC-WHtGGM:&ved=0CAUQjRw&url=http%3A%2F%2Fblog.oregonlive.com%2Foregonianextra%2F2008%2F01%2Fprevious_stories_about_the_ore.html&ei=KqxAUtf_AsfxiwKN8ICQDA&psig=AFQjCNGUpf3_gCH1hVJcvlAMPleZjKbK3w&ust=1380056459008539
  • (The first four are in NH patients with PEG tubes and the last one is in GI cancer patients.)
    No study has demonstrated improved outcomes over oral feeding alone
    Percutaneous endoscopic gastrostomy (PEG) tubes increase the risk for aspiration; they do not reduce it
    Enteral feeding tubes can make matters worse and are associated with infection, obstruction, edema, ascites, and aspiration pneumonia as well as more time in restraints
    There is no evidence that enteral nutrition improves survival or improves quality of life for the advanced oncology patient or those with end-stage dementia
  • What is your diagnosis?

    What are the options? (Note she’s FAST 7D, so hospice eligible.)
  • Most patients lose their appetite
    families and professional caregivers may interpret cessation of eating as ‘giving in’ or ‘starving to death’
    Physicians can help families understand that loss of appetite is normal at this stage
    Help direct families and caregivers to find alternate ways to express their need to provide appropriate physical care and emotional support to the patient
    Remind family:
    patient is not hungry,
    food either is not appealing or may be nauseating,
    patient would likely eat if he or she could,
    clenching of teeth may be the only way for the patient to express desires
    food forced on the unwilling patient may cause problems such as aspiration and be anxiety-provoking
    Help them to find alternate ways to provide appropriate care
  • Patients and families do not want to feel like they made this decision alone. Using language such as “this is not medically appropriate” takes some of the decisional burden away from them.

    Alternatives
    There is no evidence that enteral nutrition improves energy level or survival in many patients
    With the exception of patients with a mechanical reason for not being able to eat, eg, an obstructing cancer or stroke involving deglutition, cancer patients who report anorexia and cachexia do so for a number of complex reasons
    These reasons are not reversible if the underlying cancer cannot be reversed
    Comfort feeding with speech therapy input. Risks: aspiration & infection (plan: abx or no in this case?...”Are abx a contraindication to hospice?”), increased secretions, dyspnea, etc.

    Image: https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&docid=NWT6988cBH0F8M&tbnid=gUakVFK0qWvfzM:&ved=0CAUQjRw&url=http%3A%2F%2Fwww.photojournale.com%2Fcategories.php%3Fcat_id%3D124&ei=rqxAUpu9Aa_EiwKa34CIAQ&psig=AFQjCNGeMqnKluE8J31pprFV-tcS43MmPQ&ust=1380056556545790
  • Also referred to as the fair-process approach.

    Reevaluation, then, is an assessment and sharing the plan rather than another question-and-answer session. Save the family from the hard decision.

Transcript

  • 1. Kyle P. Edmonds, MD Assistant Clinical Professor Doris A. Howell, MD, Palliative Care Service UC San Diego Health System
  • 2. Informed consent Series • The problem • What is likely • Benefits & burdens • Medically-appropriate options
  • 3. Ethical Principles • Withdrawing = withholding • Autonomy allows for pt refusal of medical care • Clinicians balance benefit & harm Ganzini M. 2006.
  • 4. Legal principles • US case law: artificial nutrition is a medical intervention & can be refused (Cruzan) • Specific requirements will vary state-to-state Ganzini M. 2006.
  • 5. Case 86 year old woman with FAST 7D Alzheimer-type dementia is on her third admission from her board & care in six months for sepsis of urinary origin. Her infection has improved and she is nearing discharge. As you are leaving the room early in the morning on her final day the daughter says “oh, doc, she’s not eating very much and when she does, she coughs. Oh and she’s been losing weight…”
  • 6. AD Likely course • Eating problems develop in 86% w advanced dementia  39% die w/in 6 mos  2/3 of NH residents don’t want a FT Teno, 2011.
  • 7. AD Likely course Mitchell SL. 2009. No dysphagia Dysphagia
  • 8. AD Last 3 Months: morbidity • Pneumonia (37%) • Fever (32%) • Eating problems (90%) Mitchell SL. 2009.
  • 9. Physiology in Dying • Constitutional  Weakness  Fatigue • GI:  Loss of ability to swallow  Dehydration  Ileus  Symptoms: anorexia; nausea; dry mouth
  • 10. What are pt / family goals? • Desire to  Improve strength  Avoid “starvation” • Meaning of food / eating
  • 11. Patient/Family Meaning •“Food” = ?
  • 12. Patient/Family Meaning •No! “Food” =
  • 13. Patient/Family Meaning-Making Johnson et al., 2011.
  • 14. Specific Disease States • Artificial nutrition may be a “Bridge” therapy in: • Severe mucositis (H&N CA, BMT) • Acute stroke with dysphagia • Early ALS (before Resp Failure) • Obstructions (H&N CA or GI CA)
  • 15. Burden of ANH • Breathlessness • Edema • Ascites • Nausea / vomiting • Polyuria
  • 16. Outcomes… Ganzini M. 2006.; Teno J. 2011. •IncreasedMortality •IncreasedTime in restraints •IncreasedIn-hospital mortality •IncreasedComplication rate
  • 17. …Outcomes Ganzini M. 2006. •Increased Aspiration PNA •Same (worse?) Skin integrity •Same (worse?) Wound healing •Same (worse?) Symptom control
  • 18. Case 86 yoF with advanced dementia & recurrent infections now with weight loss and anorexia Found by SLP to have aspiration with all consistencies. Diagnosis? Options?
  • 19. Decreasing food intake • Fear: Starvation • Management  Normalize & Reframe  Food for comfort  Aspiration risk
  • 20. Role of the team 1. Diagnose dying 2. Use “not medically appropriate” 3. Assure comfort, non-abandonment 4. Discuss alternatives 5. Develop clear time-limited trials 6. Involve, inform other members (RN, SLP)
  • 21. Potential Goals of Care Restorative or Cure Return to Baseline Improve Survival Improve Function Relieve Symptoms Allow Natural Death Adapted from Mulkerin, 2011.
  • 22. Decision-making Pendulum Paternalism Autonomy
  • 23. Values Hopes Wishes Personhood Lifestory Goals of Care Medical Options Patient/Family Clinicians Ventilator Pressors Code Status Antibiotics Disposition The Plan of Care
  • 24. Time-Limited Trials • A structured medical intervention • Gather all parties • Agree on:  Exact length of time  Specific goals (reasons to continue)  Specific burdens (reasons to stop)  What will happen if goals not met • Reevaluation
  • 25. Evidence conclusion Destination therapy with artificial enteral nutrition is a burdensome intervention with very limited medical-appropriateness. In cases where family is resistant to this recommendation, a structured time- limited trial would be appropriate.
  • 26. Palliative Care is… • A team that can help your patients and families manage the pain, symptoms, and stress of serious illness. • Available at any age and at any stage in a serious illness and can be provided along with curative treatment. • Expert communication for challenging situations. • Partnering with you for better outcomes by helping your patients tolerate curative treatment.
  • 27. References • Finucane TE, Christmas C, Travis K. Tube feeding in patients with advanced dementia: A review of the evidence. JAMA 1999;282:1365–1370. • Ganzini, Linda. "Artificial Nutrition and Hydration at the End of Life: Ethics and Evidence."Palliative and Supportive Care 4 (2006): 135-43. PMID: 16903584 • Koretz, Ronald L., MD. "Do Data Support Nutrition Support? Part I: Intravenous Nutrition."Journal of the American Dietetic Association 107 (2007): 988-96. PMID: 17524720 • Koretz, Ronald L., MD. "Do Data Support Nutrition Support? Part II: Enteral Artificial Nutrition."Journal of the American Dietetic Association 107 (2007): 1374-1380. PMID: 17659905 • Mitchell, SL et al (2009). The Clinical Course of Advanced Dementia. NEJM. 361 (16). 1529-1538. • Teno JM et al. (2011). Decision-making and outcomes of feeding tube insertion: A five- state study. J Am Geriatr Soc. 59: 881-886.