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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

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slide1

A Transformative Year for Palliative CareTop Practice Changing (or Practice Validating) Articles2013-2014

Russell Goldman MD, MPH, CCFP

Ramona Mahtani MD, CCFP

disclosure past 2 years
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

what s already known
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
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?

methods
Methods
  • Participants baseline Interview
  • Medical Chart Review at study enrollment:
  • Confirmation with Physician: performance status and prognosis <6mo
additional covariates measured at baseline
Additional Covariates Measured at Baseline
  • Sociodemographic characteristics
  • Health Status Measures:
    • McGill Quality of Life Index, Charlson Comorbid Index, ECOG, Karnofskyscore
  • Treatment preferences
sample patient interview
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…”

slide15

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?”

slide16

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

author s conclusions
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.

slide24

“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

slide25

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

purpose
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

methods1
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
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
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

results1
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).
author s conclusions1
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
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 known1
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

slide39

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
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
Intervention

Dexamethasone 4mg OR Placebo po bid x 14d

outcome measures
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)
limitations
Limitations!

Dose

Duration

Beyond 2 weeks -- Effects wane, Adverse effects increase

Cluster Symptoms

Not assessing an integrated holistic, multidisciplinary approach

slide51

Diagnose underlying multifaceted processes involved in fatigue:

Physical (dexamethasone responsive?) VS. Emotional, Relationships, Spiritual, Functional

Consider pain control, exercise, sleep hygiene, nutrition

slide53

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
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
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

Ifa 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

slide56

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
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%)

results2
Results

With opioids, bowel prophylaxis 52.2% of outpatients vs70.5% 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 think1
What do you think?

Indicators?

Applicability to our cancer centres?

Take aways?

conclusions
Conclusions

Development of a toolkit to support quality improvement in supportive and palliative care

implications for the health c are s ystem
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”