A Transformative Year for Palliative Care Top Practice Changing (or Practice Validating) Articles 2013-2014 Russell Goldman MD, MPH, CCFP Ramona Mahtani.

A Transformative Year for Palliative Care

Top Practice Changing (or Practice Validating) Articles 2013-2014

Russell Goldman MD, MPH, CCFPRamona Mahtani MD, CCFP

April 2014: “pain management in the elderly” for oncologists sponsored by Purdue

December 2013: Advisory Board participant for Teva Pharmaceuticals on SL fentanyl

Disclosure: past 2 years

Transformative Paradigm in Palliative Care

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

What’s Already Known…

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?

Objective of Study:

Participants baseline Interview

Medical Chart Review at study enrollment:

Confirmation with Physician: performance status and prognosis <6mo

Methods

Sociodemographic characteristics

Health Status Measures: McGill Quality of Life Index, Charlson Comorbid Index, ECOG,

Karnofsky score

Treatment preferences

Additional Covariates Measured at Baseline

“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…”

Sample Patient Interview

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?”

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

Results

Total Yes Chemo No Chemo

What do you think?

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.

Author’s conclusions

“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 longer-term 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”

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

What’s already known

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

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

Inclusion Criteria

Dexamethasone 4mg OR Placebo po bid x 14d

Intervention

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)

Outcome Measures

‘No interest’ + ‘Too much burden’=25%

Mean Difference =5.9

Mean difference= -6.0

What do you think?

Dose Duration Beyond 2 weeks -- Effects wane, Adverse effects

increase Cluster Symptoms Not assessing an integrated holistic,

multidisciplinary approach

Limitations!

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

“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”

Implications for the Health Care System

Summary