Transcript Results - Compassus

2016 State-of-the-Art
Hospice & Palliative Medicine
Literature Review
Kurt P. Merkelz, MD, CMD
Compassus – Houston
Eitayo “Mike” Odeniyi, DNP, RN, GNP-BC
Director Palliative Care Services – St. Lukes Hospital, Houston
GeriPal: A Geriatrics and Palliative Care Blog
Trial
Randomized, double-blind, placebo-controlled trial of oral docusate in
the management of constipation in hospice patients
(Tarumi. Et.al., J. Pain Sxm Mgmt, 2013)
• 10-day, prospective, randomized, double-blind, placebo-controlled trial of
docusate and sennosides vs. placebo and sennosides in hospice patients
• Primary outcome measures were stool frequency, volume, and consistency
• Secondary outcomes were patient perceptions of BM and bowel-related
interventions
• N=74
Results
• NO significant benefit of docusate plus sennosides
compared with placebo plus sennosides in managing
constipation in hospice patients
• For patients on opioids, recommend a stimulant
laxative to increase GI motility
• Look for constipation-provoking medications – iron,
calcium, anticholinergics (oxybutynin, atropine,
scopolamine)
Study
Once daily opioids for chronic dyspnea: a dose increment and
pharmacovigilance study
(Currow et al, jpainsymman, 2011)
• Goals:
• Determine minimum effective once-daily dose of SR Morphine
• Are net clinical benefits sustained safely?
• Phase 2 dose increment study
• Morphine SR 10mg daily
• ↑ in non-responders by 10mg daily weekly up to 30mg daily
• Participants with 10% improvement over own baseline joined a long term
phase 4 effectiveness/safety study at that dose
Results
• 83 participants provided more than 30 patients-years of
data
– 53 males
– Mean age 75 years
– 54% with COPD
• 52 participants derived ≥ 10% benefit
– On average 35% improvement over baseline
– 70% - dose was 10mg/24h
– 28 participants (33%) maintained benefits at 3 months
Results
• Breathlessness significantly ↓
• Constipation ↑ despite laxatives
• No episodes of respiratory depression or
hospitalizations
• 1 in 3 people continued to derive benefit at 3 months
• Conclusion: 10 mg of SR oral Morphine once daily is
safe and effective for most people who respond
Trial
Effect of palliative oxygen vs. room air in relief of breathlessness in
patients with refractory dyspnea: a double-blind, randomized
controlled trial
(Abernathy, et.al., Lancet, 2010)
• Palliative oxygen therapy is widely used in response to dyspnea, dropping
oxygen saturations, as a routine “comfort” intervention and to support
anxious family members
• 239 terminally ill patients with refractory dyspnea
• Randomly assigned to oxygen or air via nasal cannula for 7 days for at least
15 hrs/day
Results
• Dyspnea measured by NRS (0-10) morning and evening
• Oxygen provided no additional symptomatic benefit in
non-hypoxemic, dyspneic patients
• Cochrane review (Cranston. Et.al., 2009)
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8 RCTs with 144 participants
Cancer – 97
Heart failure – 35
No consistent beneficial effect of oxygen inhalation over air
inhalation
Take Home Message
• Declining oxygen saturation is naturally occurring and
expected
• Declining oxygen saturation may predict but does not
signify respiratory distress
• The routine application of oxygen to most patients who
are near death is not supported
• An n-of-1 trial is appropriate in the face of respiratory
distress
Study
Does Feeding Tube Insertion and its Timing Improve Survival?
(Teno et al, J Am Geriatr Soc, 2012)
• Prospective cohort study
• 36,492 NH residents with advanced cognitive impairment from dementia
and new eating problems
• 88.4% white, mean age 84.9, 87.4% with 1 TF risk factor
• 1999 and 2007
• Goals:
• Examine survival with and without a PEG feeding tube
• Examine whether the timing of feeding tube insertion affected survival
• Measurements: Survival after development of the need for eating
assistance and feeding tube insertion
Results
• 1,957 (5.4%) had a feeding tube inserted within 1 year of
developing a eating problem
• No difference was found in survival between the two
groups
• No association with survival between timing of PEG tube
insertion relative to onset of eating problems
• Conclusion: Neither insertion of PEG tube nor timing of
insertion affect survival
Trial
Parenteral hydration in patients with advanced cancer: a multicenter,
double-blind, placebo-controlled randomized trial
(Bruera,et.al., Jan 2013)
• The vast majority of patients with cancer at the end of life receive
parenteral hydration in hospitals, and no hydration in hospice, with limited
data supporting either practice
• Many reasons why families request this practice:
• Misconception about the value vs. burden
• Cultural beliefs
• Belief it’s the standard of care
Expanded on previous report…
Development of a National Clinical Guideline for Artificial Hydration
Therapy for Terminally Ill Patients with Cancer
(Morita. Et.al., 2007)
• Fluids worsen condition in presence of ascites, pleural effusion, edema,
bronchial secretions
• Thirst – mouth care is more effective
• Nausea – benefit if bowel obstruction
• Fatigue – benefit if several months of life left
• N=102 hospice patients with cancer diagnosis and life
expectancy > 1 week randomized to two groups
– Normal saline at 1 liter/day infused over 4 hrs (n=49)
– Normal saline at 100 cc/day infused over 4 hrs (n=53)
• Measures
– Dehydration symptoms (fatigue, myoclonus, sedation,
hallucinations)
– Delirium
– Survival
Results
• No difference between groups
• Hydration did not improve symptoms
• Hydration did not improve quality of life or survival
compared to placebo
• Largely non-beneficial in patients who are close to
death (1-2 weeks)
Trial
Effect of duloxetine on pain, function and quality of life among patients
with chemotherapy-induced painful peripheral neuropathy:
a random clinical trial
(Smith et al, JAMA, 2013)
• Objective: Determine effect of duloxetine 60mg daily, on average pain
severity
• Randomized, double-blind, placebo-controlled crossover trial
• 8 National Cancer Institute
• 231 patients, 25years old or >
• April 2008 and March 2011
• Patients were randomized to receive either duloxetine followed by placebo
or placebo followed by duloxetine
Results
• Intervention:
– Duloxetine 30mg daily or placebo for first week
– Duloxetine 60mg daily or placebo for additional 4 weeks
• Results: 59% of patients who initially received duloxetine vs.
38% of patients who initially received placebo reported
decreased pain of any amount
• Conclusion: Among patients with painful chemotherapyinduced peripheral neuropathy, the use of duloxetine
compared with placebo for 5 weeks resulted in a greater
reduction of pain
Trial
Randomized double-blind trial of sublingual atropine vs. placebo for
the management of death rattle
(Heisler, et.al., J Pain Sxm Mgmt, 2013)
• Naturally occurring upper airway sounds due to pooling of pharyngeal
secretions
• Common, with multiple studies confirming the presence in up to 45% of all
patients in inpatient units
Trial
It is a source of distress for families!
Bereaved Relatives – Semi-structured Interviews
(Wee. Et.al., J Pall Med, 2006)
50% surveyed were distressed by the sound
50% found it helpful/neutral
Results
• N= 137, terminally ill adult hospice patients
randomized to treatment with atropine or placebo
• Given single sublingual dose
• Noise from breathing measured at 2 and 4 hours
• Differences between two groups were not significant
at either point of time
Results
• Cochrane review in 2012 looked at all studies with
medications including atropine, hyoscine and
glycopyrrolate
• No evidence that any treatment was superior over
placebo
• Advise on side-lying as tolerated
• Advise patients are often unable to report side-effects,
which can be distressing
• Advice on the “naturalness” of the process
Trial
A controlled trial to improve care for seriously ill hospitalized patients.
The study to understand prognoses and preferences for outcomes and
risks of treatments (SUPPORT)
(Connors et al, JAMA 1995)
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Aim: To improve end-of-life decision making and reduce the frequency of a mechanically
supported, painful and prolonged process of dying
Phase 1 - 2 yr prospective observational study (4301) patients
• Determine objective measure of quality of death
Phase 2 – 2 yr controlled clinical trial (intervention group n-2652; control group
n= 2152) patients
• Models developed to aid MDs in prognostication
• Trained RNs deployed to facilitate pt/family wishes/goals and encourage attention to
pain control
• Physicians provided with detailed written instructions about wishes
Results: Phase 1
• 46% of DNR orders were written within the last 2 days of life, suggesting
little advance planning
• 53% of MDs did not understand that a patient wanted to avoid CPR
• 38% of patients experienced 10+ days in the ICU, in a coma or on a
ventilator
• Half experienced moderate or severe pain at least half the time within last
few days
• Family impact: 55% had at least one of the following
– ↑ family care giving; lost most of family savings/major source of income; major life
change; other family illness R/T stress
• Significant deficiencies in care of seriously ill hospitalized patients
confirmed
Results: Phase 2
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Compared to control group:
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No difference in time in ICU, coma, or on ventilator
MDs still unaware of pt’s wishes
Pain levels remained disturbingly high
No difference in cost
1/3 families lost savings
Intervention failed to improve care or patient outcomes
Conclusion:
– Patient-physician communication is advocated as a major method for improving patient
outcomes
– It may be inadequate to change established practices
– Greater individual and societal commitment may be needed
– Proactive and forceful measures may be needed
Study
Factors considered important at the end of life by patients, family,
physicians, and other care providers
(Steinhauser, et. al., JAMA, 2000)
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Scope: A clear understanding of what patients, families and health care practitioners view as
important at the end of life is integral to the success of improving care of dying patients
Results
• Random national survey
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340 seriously ill patients
332 bereaved family
361 physicians
429 other care providers (nurses, social workers, chaplains,
volunteers)
Results
• Asked to rate the importance of 44 attributes of
experience at end of life
• 26 items were rated as being important (>70%) across all
four groups including:
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Pain and symptom management
Preparation for death
Achieving a sense of completion
Decisions about treatment preferences
Being treated as a “whole person”
Results
• Response rate to the survey was strong: 77% patients to
96% chaplains
• There was a second category, attributes rated as high by
more than 70% of patients, but not by physicians:
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Being mentally aware
Having funeral arrangements planned
Feeling that one’s life was complete
Not being burden
Coming to peace with God, and praying
Results
• Rank-ordered responses showed that coming to peace
with God and pain control were nearly identical in
importance for
• Fewer than half of all participants agreed that dying at
home was an important attribute in quality of dying;
Highest response rates were from the “other” category
• Clearly one should recognize that there is no one
definition of a good death
Communication Strategy
A Communication Strategy and Brochure for
Relatives of Patients Dying in the ICU
(Lautrette, et al, NEJM 2007)
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Family members of 126 patients dying in the ICUs in France (May 2005 to October 2005)
Randomly assigned to:
• Usual end-of-life conference at each center AND
• Intervention format
• Brochure on bereavement
• Family conference guidelines developed by one of the authors (VALUE)
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To value and appreciate what family members say
To acknowledge the family members’ emotions
To listen
To ask questions that would allow the caregiver to understand who the patient was as a person
To elicit questions from family members
Methods
• Telephone interview 90 days after death
• Impact of event Scale (IES)
– Score range 0-75
– Indicating no symptoms to severe symptoms
– Related to PTSD
• Hospital Anxiety and Depression Scale (HADS)
– 0-21
– Indicating no distress to maximum distress
Results
Group
Conference
Time Median
Talking Time
Median
IES Median
score
HADS Median
Score
Intervention
30 mins
12 minutes
27
11
Control
20 mins
5 minutes
39
17
Group
PTSD Symptoms
Anxiety
Depression
Intervention
45%
45%
29%
Control
69%
67%
56%
Study
Advance directives and outcomes of surrogate
decision-making before death
(Silveira. Et.al., NEJM 2010)
• The study which comprised 3,746 subjects looked at elderly patients
decision-making capacity
Results
• 42.5 % required decision-making
• 70.3% lacked decision-making capacity
• Nearly half of all sampled needed to make healthcare
decisions and majority lacked capacity to do so
• The article states that the majority who had living
wills received care consistent with their wishes
Study
Family satisfaction with family conferences about end-of-life care in
the intensive care unit: increased proportion of family speech is
associated with increased satisfaction
(McDonagh JR et al, Crit Care Med, 2004)
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Cross-sectional study
Family conferences in 4 Seattle hospitals
Discussions about withdrawing life support
214 family members
51 conferences were audiotaped
Measurements:
– Duration of time physicians spoke
– Duration of time family members spoke
– Survey assessing satisfaction with communication
Results
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Mean conference time was 32 minutes
Family members spoke an average of 29%
Clinicians spoke an average of 71%
Increased proportion of family speech was:
– Associated with increased family satisfaction with physician
communication
– Associated with decreased family ratings of conflict with physicians
– No association between duration and family satisfaction
• Study suggests that allowing family members more opportunity
speak during conferences may improve satisfaction
Study
Provision of spiritual support to patients with advanced cancer by
religious communities and associations
with medical care at the end of life
(Balboni. Et. al., JAMA Intern Med 2013)
•
To determine whether spiritual support from religious communities influences
terminally ill patients’ medical care and quality of life near death
Results
• 343 patients with advanced cancer followed until
death
• End-of-life medical care included: hospice, hospital,
ICU, aggressive EoL measures (resuscitation and
ventilation) and ICU death
• EoL QoL was assessed by caregiver ratings of patients
QoL in the last week of life
Results
• Patients reporting high spiritual support from religious
communities (43%) were less likely to receive hospice,
and more likely to receive aggressive EoL measures and
more likely to die in an ICU
• Among patients well-supported by religious
communities, receiving spiritual support from the
medical team was associated with higher rates of hospice
use, fewer aggressive interventions and fewer ICU deaths
Survey
Family perspective on end-of-life care at the last place of care
(Teno JM, et al, JAMA, 2004)
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To evaluate the US dying experience at home and in institutional settings
1578 decedents
Mortality follow-back telephone survey
Assessing whether health care workers:
– Provided desired physical comfort and emotional support to the dying person
– Supported shared decision-making
– Treated the dying person with respect
– Attended to emotional needs of family
– Provided coordinated care
Results
• 1057 (67.1%) died in an institution
• 519 (32.9%) died at home
– 198 (38.2%) had no home nursing services
– 65 (12.5%) had home nursing services
– 256 (49.3%) had home hospice services
• Responders reported inadequate help with pain (24.2%) and dyspnea
(22.4% ) management – higher rate reported with NH/HHC compared
to home hospice
• 1 in 4 families reported concerns with physician communication
• Recipients of home hospice care reported fewer concerns with the
amount of emotional support provided to them compared to care from
home health agency, nursing home or hospital
Results
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Nursing home residents (68.2%) compared to those cared for by home hospice
(96.2%) and in the hospital (79.6%) were less likely to be treated with respect
Family members of patients who received home hospice care were more satisfied
with overall quality of care:
– 70.7% rated care as “excellent”
– Compared with < 50% of those dying in an institutional setting or with home
health services
Conclusion: Family members of decedents who received care at home with
hospice were more likely to report a favorable dying experience
Many people dying in institutions have unmet needs for symptom amelioration,
physician communication, emotional support, and being treated with respect
Study
Extent and determinants of error in doctors’ prognoses in terminally ill
patients: prospective cohort study
(Christakis. Et. al., BMJ 2000)
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Doctors commonly have to prognosticate, most feel uncomfortable and most do it
poorly…
Many studies to date that show doctors’ predictions of survival are often
erroneous and optimistic
Results
• This was a large, prospective cohort study of terminally ill
patients in 5 hospice programs
• Final results included 343 doctors caring for 468 patients
• Only 20% of prognoses were accurate
• Most predictions (63%) were overestimates
• Doctors overall overestimated survival by a factor of 5
Results
• Moreover, the better the doctor knew the patient –
as measured, for example, by the length and
recentness of their contact – the more likely the
doctor was to err
• Matoni’s palliative predictive score (PaP)
– Prognostic variables:
• Dyspnea, anorexia, karnofsky, clinician prediction, total white cell
count, lymphocyte percentage
Study
A review of physician’s survival predictions in
terminally ill cancer patients
(Christakis, BMJ 2003)
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Review of 8 studies from 3 different countries over 30 years
Doctors consistently over predict survival in all studies, but better than
conventional performance status and symptoms
Study
Other factors that influence prognosis…
“It’s not just what the doctor tells me:” factors that influence surrogate
decision-makers’ perceptions of prognosis
(Boyd, et.al., Crit Care Med. 2010)
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Less than 2% reported that their beliefs about prognoses hinged exclusively on
information provided to them by the physician
Other factors: patients will, previous experiences, unique history, surrogates
optimism, faith, etc.
Study
Trends in Survival after In-Hospital Cardiac Arrest
(Girotra S et al, NJEM 2012)
• 84,625 hospitalized patients who had an in-hospital cardiac arrest
• At 374 Hospitals participating in the Get with the Guidelines-Resuscitation
registry
• Between 2000-2009
• Conclusions:
– Survival after in-hospital cardiac arrest improved substantially
– Decrease in the rate of clinically significant neurologic disability among
survivors
Study
Functional status of elderly adults before and after initiation of dialysis
(Tamura, et.al., NEJM 2009)
• Looked at 3702 nursing home residents who were starting dialysis
between 1998 and 2000
• Functional status was measured by assessing the degree of dependence in
7 ADLs
Results
• Within 3 months after the start of dialysis, 61% of
the nursing home residents had died or had a
decrease in functional status
• By 12 months, 87% had died or had a decrease in
functional status; close to 75% had died
Study
Patients' expectations about Effects of Chemotherapy for
Advanced Cancer
(Weeks JC, NEJM 2012)
• 1193 patients participating in the Cancer Care Outcomes Research and
Surveillance (CanCORS) study
• Newly diagnosed metastatic (stage IV) lung or colorectal cancer
• Received chemotherapy and was alive 4 months after diagnosis
• Professional interviewers utilized computer-assisted telephone interview
software
Results
• Answers not consistent with understanding that chemotherapy was
unlikely to cure their cancer
– 69% of patients with lung cancer
– 81% of those with colorectal cancer
– Non-white and Hispanics > non-Hispanic White
• Conclusions:
– Many patients with incurable cancers may not understand that chemotherapy
is unlikely to be curative
– Can compromise ability to make informed treatment decisions
– Need for physician-targeted education
Study
Cost savings associated with US hospital
palliative care consultation programs
(Morrison RS et al, Arch Intern Med, 2008)
• Administrative data from 8 hospitals with established palliative care
programs (2002 through 2004)
• Patients receiving palliative care were matched by propensity score to
patients receiving usual care
– 2966 PC patients discharged alive matched with 18,427 usual care
– 2388 PC patients who died were matched to 2124 usual care patients
Results
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Palliative care patients discharged alive compared to usual care patients
– Had an adjusted net savings of $1696 in direct costs per admission and $279 in
direct costs per day
– Including significant reductions in laboratory and intensive care unit costs
•
Palliative care who died compared to usual care
– Had adjusted net savings of $4908 in direct costs per admission
– $374 in direct costs per day
– Including significant reductions in pharmacy, laboratory and intensive care unit
costs
•
Conclusion: Hospital palliative care consultation teams are associated with
significant hospital costs savings
Study
Hospice enrollment saves money for Medicare and improves care
quality across a number of different lengths-of-stay
(Kelley; Morrison, et.al., Health Affairs 2013)
• Using data from the health and retirement study, 2002-2008, and
individual Medicare claims
• $2,561 in savings to Medicare for each patient enrolled in hospice 53-105
days before death compared to matched non-hospice control
Results
• Even higher savings were seen, however, with more common,
shorter enrollment periods: $2650, $5,040, and $6430 per
patient enrolled 1-7, 8-14, and 15-30 days prior to death,
respectively
• Within all periods examined, hospice patients also had
significantly lower rates of hospital service use, intensive care
use, hospital readmissions and in-hospital death than
matched controls
• Savings are present in both cancer and non-cancer patients
Do palliative consultations improve patient outcomes
(Casaret D et al, J Am Geriatr Soc., 2008)
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Retrospective telephone surveys
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524 Family members of veterans
Received inpatient and outpatient care
Department of Veterans affairs medical facility
Last month of life
Survey assessed 9 aspects of care
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Well being and dignity
Adequacy of communication
Respect for treatment preferences
Emotional and spiritual support
Management of symptoms
Access to inpatient facility of choice
Care around the time of death
Access to home services
Access to benefits and services after the patient’s death
Results
• Palliative care patients had a higher overall score 65 vs. 54
• And higher scores for almost all domains
• Earlier consultations were independently associated with better overall
scores
• Attributed primarily to:
– Improvements in communication
– Emotional support
• Conclusion: Palliative consultations improve outcomes of care, and earlier
consultations may confer additional benefit
Study
Change in End-of-Life Care for Medicare beneficiaries. Site of death,
place of care, and heath care transitions in 2000, 2005, and 2009
(Teno et.al., JAMA 2013)
• Among Medicare beneficiaries who died in 2009 and 2005 compared with
2000, a lower proportion died in an acute care hospital, although both ICU
use and the rate of health care transitions in the last month of life
• Hospice use increased, but 28.4% of those decedents used a hospice for 3
days or less in 2009, about 1/3 of these short stay hospice stays were
preceded by an ICU stay in the last month of life
Early Palliative Care for Patients with Metastatic Non-Small –
Cell Lung Cancer
(Temel JS et al, NEJM, 2010)
• June 7, 2006 to July 15, 2007
• Massachusetts General Hospital in Boston
• Goal: To examine the effect of introducing PC early after diagnosis on
patient-reported outcomes and end-of-life care
• 151 newly diagnosed metastatic NSCLC
– 27 died by 12 weeks
– 107 completed assessments
• Enrolled in a nonblinded, randomized, controlled trial of early PC
integrated with standard oncologic care, as compared with standard
oncologic care alone
Methods
• Health related QOL was measured with the use of the Functional
Assessment of Cancer Therapy-Lung (FACT-L) scale
– Assess multiple dimensions of QOL (Physical, functional, emotional, and social
well-being)
– The lung cancer subscale (LCS) of the FACT-L scale evaluates 7 symptoms
specific to lung cancer
• The primary outcome of the study was the change in the score on the Trial
Outcome Index (TOI) from baseline to 12 weeks
– The sum of the scores on the LCS and the physical well-being and functional
well-being subscales of the FACT-L scale
Methods
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Mood was assessed with the use of both the Hospital Anxiety and Depression
Scale (HADS) and the Patient Health Questionnaire 9 (PHQ-9)
HADS (14 item)
– Screens for anxiety and depression in the previous week
– 0 (no distress) to 21 (maximum distress)
– A score higher than 7 on either subscale is considered significant
•
PHQ-9 (9 item)
– Evaluates symptoms of major depressive disorder according to the criteria of the DSMIV
– 5 of 9  MDD, with 1 of the 5 symptoms being either anhedonia or depressed mood
– Symptoms present for more than 1/2 of the time
– Suicidal thoughts included if present at any time
Methods
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Measures of health care use
– EMR for health services, resuscitation preferences and EOL care
– Aggressive care
• Chemotherapy within 14 days prior to death
• No hospice care
• Admission to hospice 3 days or less prior to death
Data collection
– Baseline questionnaire completed before randomization
– Follow up assessment at 12 weeks
Results
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Patient assigned to early PC had better QOL compared to standard group (98.0 vs.
91.5)
Patients assigned to early PC has less depressive moods compared to standard
group (16% vs. 38%)
Median survival 11.6 months PC group vs. 8.9 months standard group despite
– PC group elected to forgo aggressive chemotherapy
– Most in PC group elected to be a DNR
Conclusion: Patients receiving early PC:
– Demonstrated significant improvements in both QOL and mood
– Less aggressive care
– Longer survival
“Death is the enemy. But the enemy has superior
forces. Eventually, it wins. And in a war that you
cannot win, you don’t want a general who fights
to the point of total annihilation. You don’t want
Custer. You want Robert E. Lee, someone who
knows how to fight for territory that can be won
and how to surrender it when it can’t, someone
who understands that the damage is greatest if all
you do is battle to the bitter end.”
Atul Guwande, MD, MPH 1965- (Being Mortal)