Transcript Document 7154812

A Transformative Year for
Palliative Care
Top Practice Changing (or Practice Validating) Articles
2013-2014
Russell Goldman MD, MPH, CCFP
Ramona Mahtani MD, CCFP
Disclosure: past 2 years
 April 2014: “pain management in the elderly” for
oncologists sponsored by Purdue
 December 2013: Advisory Board participant for Teva
Pharmaceuticals on SL fentanyl
Transformative Paradigm in Palliative Care
What’s Already Known…
 Many patients with metastatic cancer receive chemotherapy in their final
months WITHOUT information on survival, future care, quality of life and
location of death
 Patients who receive chemo within 2 weeks of death are less likely to
receive hospice services, compared with those who do not
Objective of Study:
Is there an association with chemotherapy in patients last MONTHS of life and
intensive medical care in the ICU in their last WEEK?
-More likely to die in ICU?
-More likely to receive CPR, mechanical ventilation, both?
-Late referrals to hospice (home palliative care/PCU)?
-Less likely to die in preferred place?
N = 917 eligible patients for “Coping with Cancer” Study
(Metastatic, ≥1 line chemo, <6mo prognosis, >20 y, Informal caregiver,
Adequate stamina to complete interview, English/Spanish language
N = 638 consented & enrolled
Non participation (not interested n=120; “other” n=69; caregiver refuses n=37)
N = 386 died during study interval (Oct 2002-Feb 2008)
Excluded if on clinical trials* (n=37),
Refusal from one of Patient-Caregiver dyad, Dementia or Delirium
Methods
 Participants baseline Interview
 Medical Chart Review at study enrollment:
 Confirmation with Physician: performance status and prognosis <6mo
Additional Covariates Measured at Baseline
 Sociodemographic characteristics
 Health Status Measures:
 McGill Quality of Life Index, Charlson Comorbid Index, ECOG, Karnofsky
score
 Treatment preferences
Sample Patient Interview
“If you could choose, would you prefer:
1) a course of treatment that focused on extending life as much as possible, even
if it meant more pain and discomfort, or
2) on a plan of care that focused on relieving pain and discomfort as much as
possible, even if that meant not living as long?”
“Would you take chemotherapy and risk side effects such as…or have to spend
more time in the hospital if it would keep you alive for ‘___’ time…”
Q for Patient: “Do you think it would be a bad thing for a person to
die in the ICU versus elsewhere (e.g., home, hospital, and hospice)?”
Q for Caregiver: “Do you think that (PLACE OF DEATH) was where
(PATIENT) would have most wanted to die?”
Results
 56% participants were receiving palliative chemo on study
enrollment (N=386)
 Died median of 4 months (1.8-8.3 m0) after enrollment in study
 Survival same in both groups
Total
Yes Chemo
No Chemo
What do you think?
Author’s conclusions
 Our study has important implications for oncology providers, patients
with advanced cancer, and caregivers facing decisions about treatment.
It suggests that end of life discussions may be particularly important for
patients receiving palliative chemotherapy, who should be informed by
data on the likely outcomes associated with its use. The findings also
suggest the need for oncology providers to elicit patients’ preferred site
of death to ensure that patients’ end of life experiences are congruent
with their values.
 “Palliative Chemotherapy” as an exclusion criteria for
Palliative Care Programs?
 “Time-outs” involving interdisciplinary &
interprofessional teams to reflect & avoid inadvertently
‘treating ourselves’ in offering interventions without benefit
& with potential to harm at end of life
Advance Care Planning discussions need to consider the longerterm path patient’s and family’s are sent on when decisions are
made earlier in their disease trajectory
Emerging
, Practical
Evidence
Base
Purpose
 Cancer patients at end of life majority in hospital receive
parenteral hydration; majority in “hospice” do not
 Limited evidence supporting either practice
 RCT to determine the effect of hydration on symptoms
associated with dehydration, quality of life, and survival in
patients with advanced cancer
Methods
 Intervention
 1000 ml SC daily over 4 hours
 Control
 100 ml SC daily over 4 hours
 Blinding: different nurse started infusion; pump in a backpack
with counterweight
 End point
 Unresponsive; progressive coma or died
Measures
 “fatigue, myoclonus, sedation, hallucinations, pain, nausea,
depression, anxiety, drowsiness, shortness of breath, appetite,
feelings of well-being, and sleep, was assessed using the
Edmonton Symptom Assessment Scale (ESAS)”
 Primary outcome change in sum of four dehydration symptoms
(bold) day 4 and baseline
Measures (cont)





Memorial Delirium Assessment Scale
Richmond Agitation Sedition Scale (RASS)
Nursing Delirium Screening Scale (NuDESC)
Unified Myoclonus Rating Scale (UMRS)
QoL and fatigue during the last 7 days using the Functional Assessment of Chronic
Illness Therapy–Fatigue (FACIT-F) questionnaire.
 Physical assessement (mucous membranes, axillary moisture & sunkenness of
eyes
 Baseline, day 4 and then q3-5 days
Results
Results
 No significant differences between the two groups for:
 Change in the sum of four dehydration symptoms (−3.3 v
−2.8, P = .77), ESAS (all nonsignificant)
 MDAS (1 v 3.5, P = .084),
 NuDESC (0 v 0, P = .13),
 UMRS (0 v 0, P = .54) by day 4.
 Results for day 7, including FACIT-F, were similar
 Survival did not differ between the two groups (median, 21 v 15
days, P = .83).
What do you think?
Author’s Conclusions
“In conclusion, our results suggest that in patients with
advanced cancer who are mildly to moderately dehydrated and
within days to weeks of death, parenteral hydration at 1,000 mL
per day does not improve symptoms associated with
dehydration, QoL, or survival as compared with placebo”.
Author’s Conclusions (cont)
“Our study supports current hospice practice of not
administering hydration routinely. Further studies are required
to determine whether any subgroups, such as delirious patients
or those with longer survival, would benefit from parenteral
hydration”
What’s already known
 Cochrane Review (2010) – mixed results for all pharmacologic
treatment vs. placebo for CRF
 Prior positive studies did not use validated outcome measures,
not adequately powered
 No Double-Blind, Randomized Placebo Controlled Trial
 Primary Objective: Effect of Dexamethasone and Placebo on CRF
using validated instrument
 Secondary Objective: Role of Dexamethasone in anorexia,
anxiety, depression and symptom distress scores
 Location: Outpatient clinic for pain management, palliative care,
Oncology at 4 unique sites
Inclusion Criteria
 Advanced cancer
 Moderate to Severe CRF clinical cluster symptoms = ≥ 3 symptoms
during previous 24hrs (pain, fatigue, nausea, anorexia/cachexia, sleep
problems, depression, poor appetite) with ≥ 4 on ESAS
 Normal cognition
 No infection
 Hemoglobin >90 within week of enrollment
 Life expectancy ≥4 weeks
 No AIDS
 ANC ≥750 within week of enrollment
 No diabetes in last 2 weeks and no surgery in last 2 weeks
Intervention
Dexamethasone 4mg OR Placebo po bid x 14d
Outcome Measures
 FACIT-F:
 validated, quality of life instrument (CRF clinical trials)
 27 general quality of life questions divided into 4 domains (physical, social,
emotional, functional)
 13 item FACIT-F fatigue subscale
 FAACT
 ESAS
 HADS
 Monitored for Adverse Events (National Cancer Institute Common Toxicity
Criteria)
‘No interest’ + ‘Too much
burden’=25%
Mean Difference =5.9
Mean
difference= -6.0
What do you think?
Limitations!
 Dose
 Duration
 Beyond 2 weeks -- Effects wane, Adverse effects increase
 Cluster Symptoms
 Not assessing an integrated holistic, multidisciplinary
approach
Diagnose underlying multifaceted processes involved in fatigue:
 Physical (dexamethasone responsive?) VS. Emotional,
Relationships, Spiritual, Functional
 Consider pain control, exercise, sleep hygiene, nutrition
Transforming Care through Development of
Quality Indicators
 IMPORTANCE Characterizing the quality of supportive cancer
care can guide quality improvement.
 OBJECTIVE: To evaluate nonhospice supportive cancer care
comprehensively in a national sample of veterans.
Design Setting and Participants
 Retrospective cohort stage IV pancreatic, colorectal and lung
cancer
 719 Veterans in 2008
 Measured evidence based supportive care using Cancer
Quality ASSIST Indicators
 pain, nonpain symptoms, and information and care planning
Cancer Quality ASSIST Examples
 If a cancer patient has a cancer-related outpatient visit then there
should be screening for the presence or absence and intensity of
pain using a numeric pain score
 If a patient with cancer pain is started on a long-acting opioid
formulation, then a short-acting opioid formulation for
breakthrough pain should also be provided
 If an outpatient with cancer not receiving chemotherapy or radiation is
treated for nausea or vomiting with an antiemetic medication, then the
effectiveness of treatment should be evaluated before or on the next visit
to the same outpatient site
 If a patient with advanced cancer dies an expected death, then s/he should
have been referred for palliative care prior to death (hospital-based or
community hospice) or there should be documentation why there was no
referral
Results (just a sample)
 719 veterans triggered a mean of 11.7 quality indicators (range,
1-22) and received a mean 49.5% of appropriate care.
 inpatient pain screening 96.5% vs outpatients 58.1%
 Few patients had a timely dyspnea evaluation (15.8%) or
treatment (10.8%)
Results
 With opioids, bowel prophylaxis 52.2% of outpatients vs 70.5% of inpatients.
 Of patients at high risk for diarrhea from chemotherapy, 24.2% were offered
appropriate antidiarrheals
 17.7% of veterans had goals of care addressed in the month after a diagnosis
of advanced cancer, and 63.7% had timely discussion of goals following
intensive care unit admission.
 86.4% of decedents were referred to palliative care or hospice before death.
What do you think?
 Indicators?
 Applicability to our cancer centres?
 Take aways?
Conclusions
Development of a toolkit to support quality improvement in supportive
and palliative care
Implications for the Health Care System
“One important implication is that tools are available to assess the extent
to which supportive care quality might be better or worse outside the VA.
Given the National Quality Forum endorsement of Cancer Quality–ASSIST
indicators as well as other similar measures, such as those from the Quality
Oncology Practice Initiative in recent standards, our results support the
application of the Cancer Quality–ASSIST indicators more widely”
Summary