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Update in Palliative Medicine

Update in Palliative Medicine. Erik K. Fromme, MD Oregon Health & Science University School of Medicine Mark Hughes, MD Johns Hopkins University School of Medicine Sonni Mun, MD Mount Sinai School of Medicine. Acknowledgments. AAHPM Nate Goldstein, MD, MPH Dan Fischberg, MD SGIM

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Update in Palliative Medicine

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  1. Update in Palliative Medicine Erik K. Fromme, MD Oregon Health & Science University School of Medicine Mark Hughes, MD Johns Hopkins University School of Medicine Sonni Mun, MD Mount Sinai School of Medicine

  2. Acknowledgments • AAHPM • Nate Goldstein, MD, MPH • Dan Fischberg, MD • SGIM • Bob Arnold, MD • Tim Quill, MD • Helen Fernandez, MD

  3. How Articles Were Selected • Selection criteria • Quality of science • Potential for impact • Appeal to breadth of interest • Hand search of Medline Keyword Search and Shaare-Zadek online database (3,679 articles, whew!) • Hand search of leading journals (NEJM, Annals Int Med, Lancet, BMJ, J of Clin Oncology, JGIM, J of Pall Med, J of Pain & Symptom Mgmt)

  4. Take Home Messages • Address goals of care and consider hospice when a nursing home patient’s status changes • Be aware of complicated grief, which is common and doesn’t respond to anti-depressants • Exploring creative ways for making patients’ lives meaningful is so worthwhile • Morphine and gabapentin together are better than either alone for neuropathic pain • Direct Decompressive Surgery + radiation is better than radiation alone for acute spinal cord compression due to metastatic cancer

  5. Case 1 • Myra, 83 • Alzheimer’s Dz. • FAST stage 7C • Nursing home • Aspiration pneumonia • SNF • IM clinic

  6. Improving the Use of Hospice Services in Nursing Homes Casarett D, Karlawish J, Morales K, Crowley R, Mirsch T, Asch DA. JAMA. 2005; 294:211-217

  7. Background • 1 in 4 Americans die in nursing homes • Evidence that care is often sub-optimal • 25% with daily cancer pain receive no pain meds • Frequent transfers to hospital for aggressive treatment in last weeks of life • Hospice care associated with improvements in these and other outcomes • More likely to have pain assessed, receive better pain management, and lower rates of physical restraint • Only 1 in 4 residents enroll in hospice before death • Can an intervention that promotes communication about hospice care increase hospice enrollment?

  8. Methods • RCT of residents and surrogates in 3 US nursing homes • All residents eligible unless already hospice enrolled or too cognitively impaired + no surrogate • 400 screened • 205 randomized and surrogate +/- resident interviewed • Interview assessed hospice appropriateness if • Goals of care identified as comfort • Refused CPR and mechanical ventilation • At least one need for palliative care identified

  9. Methods: Intervention vs. control • For control residents • All given description of hospice, and hospice appropriate residents told how to learn more • Intervention: • Feedback to physicians via fax that asked • Was the patient’s prognosis < 6 months? • Should NH staff contact hospice for a referral? • Outcome Measures • Hospice enrollment within 30 days • Family ratings of the quality of care for residents that died in 6 month follow-up period

  10. Results • 107 residents randomized to intervention and 98 to usual care • Physicians responded to faxes for 101/107 pts • More hospice appropriate among usual care! (50% vs. 33%) • Key findings: • 21/107 (20%) of intervention residents vs. 1/98 (1%) of usual care residents were enrolled in hospice within 30 days, P<0.001 • For patients who died, intervention families rated the quality of care higher than usual care families died (4.1/5 vs. 2.5/5, P=0.04)

  11. Key Issues • Is the question important? • Are the results valid? • Could patients whose in the control group have been subtly discouraged from enrolling in hospice? • Only 11% of study patients died within 6 mos • Can I apply the results to my patients? • Sample representative of US nursing home population

  12. Clinical Bottom Line • A screening and communication intervention in a nursing home can increase hospice referral and may improve family satisfaction with end-of-life care. • Address goals of care and consider hospice when a nursing home patient’s status changes

  13. Case 2 • Tom, 62, served as his mother’s paid caregiver for the past 10 years. • 1 month after her death following a long ICU stay, Tom called me to question whether her care had been aggressive enough. • During the phone call Tom sobbed, saying he was about to be evicted from her appt & didn’t know where he would go or what he would do.

  14. Treatment of Complicated Grief: A Randomized Controlled Trial • Shear K, Frank E, Houck PR, Reynolds III CF • JAMA. 2005;293:2601-8

  15. Background • Many physicians are uncertain how to identify bereaved individuals who need treatment and what treatment exactly is Clinical features of complicated grief • Separation distress symptoms (3 of 4) • Intrusive thoughts, yearning, searching, excess loneliness • Traumatic distress symptoms (4 of 8) • Futility/purposelessness, numbness/detachment, disbelief, life meaningless, part of oneself has died, shattered worldview, assumes harmful behaviors/symptoms of decedent, excessive irritability/anger • Duration > 6 months • Impairment in function, significant (social, job, etc.) -- Prigerson HG et al. Br J Psychiatry 1999;174:67-73

  16. Background • Complicated grief is common • 10-20% of bereaved persons • 1 million people/year • Co-occurs with depression (21% to 54%) and PTSD (30-50%) • Treatment of concomitant depression doesn’t relieve complicated grief symptoms

  17. Methods • Design: RCT comparing 2 treatments • Complicated Grief Therapy • Interpersonal Psychotherapy • Subjects: recruited from a University-based mental health clinic and a community-based clinic serving primarily low-income African Americans • Eligibility based on diagnosis of complicated grief by ‘evaluator’ and score on ‘Inventory of Complicated Grief’ instrument

  18. 1: Complicated Grief Treatment • 16 weekly sessions • ‘Exposure’ techniques based on PTSD treatments approach event as a trauma • Allows subjects exposure to aspects of the death that were persisting problems over time • Techniques to promote connection to the deceased • Imaginal conversation with deceased

  19. 2: Interpersonal Psychotherapy • 16 weekly sessions • Well established treatment for depression • Focused on grief and other interpersonal problems

  20. Results • 218 patients assessed • 116 Excluded (19 refused) • 102 Randomized • 51 Assigned to complicated grief therapy • 51 Assigned to interpersonal psychotherapy • Groups similar • Median time since loss = 2 years! • 49% currently depressed; 46% current PTSD • 1 in 3 decedents died violently • Relationship: 26% spouses, 26% parents, 26% children, 17% other

  21. Outcomes

  22. Key Questions • Is the question important? • The problem is important, but is there a solution? • First treatment that specifically targets complicated grief symptoms • Are the results valid? • By the strictest standards, this was a negative study • Can I apply the results to my patients? • Recruited from a mental health clinic, so self-referral bias applies • Complicated grief therapy may be hard to replicate

  23. Bottom line • Primary care physicians should be aware of complicated grief, which is common and doesn’t respond to anti-depressants • Complicated grief therapy shows promise

  24. Case 3 • Mr C. is a 29 year old with unresectable pancreatic cancer. • He is emotionally distraught because he has a 6 year old daughter and is fearful that she will not remember him after he dies. He also feels guilty because his wife has had quit her job to care for him. • What can you do to ease his psychosocial and existential suffering?

  25. Dignity Therapy: A Novel Psychotherapeutic Intervention for Patients Near the End-of-Life • Chochinov HM, Hack T, Kristjanson LJ, McClement S, Harlos M • Journal of Clinical Oncology 2005:23(24)5520-5

  26. Background • Although the pursuit of dignity frequently underlies various approaches to end-of-life care, its therapeutic implications are frequently uncertain • Undermining of dignity is strongly associated with depression, anxiety, desire for death, hopelessness, feeling of being a burden, and overall poorer quality of life. • Purpose of this study was to examine a brief, individualized psychotherapeutic intervention: dignity therapy

  27. Methods • Design: uncontrolled pre vs. post intervention trial • Palliative care patients in Perth, Australia and Winnipeg, Canada • Patients eligible if they had < 6 month prognosis, 18+ years old, English speaking, no cognitive impairments, and would commit to 3-4 contacts over 7-10 days • Measures pre and post included single item indicators of suffering, dignity, depression, anxiety, hopefulness, desire for death, sense of well being, will to live, and the Edmonton Symptom Assessment Scale

  28. Protocol • Visit 1-2: Dignity Psychotherapy Interview • Visit 2-3: Audiotape of interview transcribed, edited, and reviewed with patient • Non-central text removed • Clarification/correction • Ensuring nothing harmful to transcript’s recipients • Finding a statement/theme that provided an appropriate ending • Visit 3-4: Revised and edited transcripts read back to patient = ‘Generativity Document’

  29. Dignity Therapy Questions • Tell me a little about your life history, particularly the parts that you think are the most important? When did you feel most alive? • Are there specific things that you would want your family to know about you, and are there particular things you would want them to remember? • What are the most important roles you have played in life? Why were they so important to you? • What are your most important accomplishments, and what do you feel most proud of?

  30. … Dignity Therapy Questions • What are your hopes and dreams for your loved ones? • What have you learned about life that you would want to pass on to others? What advice or words of guidance would you wish to pass along to your (son, daughter, husband, etc.) • Are there words or perhaps even instructions that you would like to offer your family to help prepare them for the future? • In creating this permanent record, are there other things you would like included?

  31. Results • Enrolled 100/181 patients (50 in each site) • 50 too ill, 31 refused • 97% cancer, mean age 64, 37% less than high school education, mean survival 51 days • Post assessment: • 91% satisfied or highly satisfied w. process • 76% heightened their sense of dignity • 68% increased sense of purpose • 67% increased sense of meaning

  32. Key Findings • Pre-post comparisons • Suffering and depressed mood showed significant improvements • Dignity, hopelessness, desire for death, anxiety, will to live, and ESAS showed non-significant changes favoring improvement • Well-being and current QOL worsened but not significant

  33. …Key Findings • Patients with more initial psychosocial despair more likely to find the intervention helpful and/or satisfactory • Finding dignity therapy helpful was significantly correlated with: • Feeling life more meaningful P<0.0001 • Heightened sense of purpose P<0.0001 • Lessened suffering P=0.008 • Increasing will to live P=0.004

  34. Key Issues • Is the question important? • Psychosocial and existential suffering common at end of life • Few non-pharmacologic interventions • Current therapies provide emotional analgesia/anesthesia without addressing source or cause

  35. …Key Findings • Are the results valid? • Feasibility study • International RCT underway to evaluate dignity therapy • What are the results? • Promising results showing significant improvements in some measures of psychosocial suffering • No harm

  36. …Key Findings • Can apply the results to my patients? • Cancer patients • Older patients • Practitioners’ ability to learn proper techniques of this therapy (not a pill)

  37. Clinical Bottom Line • Dignity therapy is feasible and appears effective but more studies are necessary • Practitioners should use every clinical encounter as an opportunity to acknowledge, reinforce, and where possible, reaffirm the personhood of their patients

  38. Case 4: • Mrs S. is a 76 year old patient with diabetes mellitis for twenty years who you are seeing for the first time. • She complains of burning pain in her feet. She rates the pain as 6 out of 10. • She has previously tried amitryptilline, Percocet, and gabapentin but had inadequate analgesia or dose limiting side effects with each. • She wants to know if there is another option.

  39. Morphine, gabapentin, or their combination for neuropathic pain • Gilron I, Bailey JM, Tu D, Holden RR, Weaver DF, Houlden RL. • N Engl J Med. 2005; 352: 1324-34.

  40. “If you remember, I did mention possible side effects.”

  41. Background • Neuropathic pain is a common problem in primary care • First line therapies only reduce pain 26 to 38 percent due to incomplete efficacy, dose limiting side effects, or both • Opioids often combined with gabapentin in clinical practice but no RCT to show this is efficacious

  42. Methods • Randomized, double-blind, cross-over trial • Active placebo (lorazepam) control • Not paid for by Pfizer (but lead author has served on a paid advisory board for Pfizer…) • Subjects with daily moderate pain > 3 months • Diabetic neuropathy • Post-herpetic neuralgia

  43. …Methods • Additional inclusion criteria • Age 18 – 89 • Normal hepatic and renal function • English speaking • Exclusion criteria • Another condition resulting in > pain • Unstable cardiac disease • Any central neurological diseas • Serious mood disorder • History of substance abuse • Lack of primary care physician

  44. …Methods • Randomized to 4 blocks • Each block is 5 weeks • 1st to 3rd weeks: Titration of drug to target dose or maximum tolerated dose • 4th week: Maintenance • 5th week: Taper and washout

  45. Target Daily Drug Dose (mg) for each of the 4 groups: Standard > 60 yrs or < 60 kg

  46. Measures • Primary outcome Measure: • Mean pain score on maximal tolerated dose • Scale of 0 to 10 rated three times a day • Averaged daily ratings for week 4 (max dose) • Secondary outcome measures • Adverse effects • Short-Form McGill Pain Questionnaire • Pain interference (Brief Pain Inventory) • Mood (Beck Depression Inventory) • Health status (SF 36 Health Status • Mental status (Mini Mental Status Exam) • Global pain relief (pain worse, no relief, slight relief, moderate relief, a lot of relief, complete relief)

  47. Results • 57 subjects randomized • No baseline group differences • Only one non-white subject • 41 subjects completed trial

  48. Key Findings: Mean Pain Score% with Mod. Relief (Baseline = 5.7)

  49. Adverse Effects at Max Dose • Combination less constipating than morphine • 21% Combo • 39% Morphine • 2% Gabapentin • But more dry mouth than morphine or gabapentin • 21% Combo • 5 % Morphine • 6% Gabapentin • Sedation and cognitive dysfunction worse, but not statistically significantly worse

  50. Key Issues • Is the question important? • Neuropathic pain common and challenging • Are the results valid? • Blinding not entirely effective • Adequate dosing? • Can I apply the results to my patients? • Extrapolation to other neuropathic conditions? • Moderate pain at baseline • Tolerated doses may be different • Adherence concerns • Adverse effects may be greater • Costs significant

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