Emergency Department-Initiated Palliative Care in Advanced Cancer: A Randomized Clinical Trial

Abstract

Importance: The delivery of palliative care is not standard of care within most emergency departments (EDs).

Objective: To compare quality of life, depression, health care utilization, and survival in ED patients with advanced cancer randomized to ED-initiated palliative care consultation vs care as usual.

Design, setting, and participants: A single-blind, randomized clinical trial of ED-initiated palliative care consultation for patients with advanced cancer vs usual care took place from June 2011 to April 2014 at an urban, academic ED at a quaternary care referral center. Adult patients with advanced cancer who were able to pass a cognitive screen, had never been seen by palliative care, spoke English or Spanish, and presented to the ED met eligibility criteria; 136 of 298 eligible patients were approached and enrolled in the ED and randomized via balanced block randomization.

Interventions: Intervention participants received a comprehensive palliative care consultation by the inpatient team, including an assessment of symptoms, spiritual and/or social needs, and goals of care.

Main outcomes and measures: The primary outcome was quality of life as measured by the change in Functional Assessment of Cancer Therapy-General Measure (FACT-G) score at 12 weeks. Secondary outcomes included major depressive disorder as measured by the Patient Health Questionnaire-9, health care utilization at 180 days, and survival at 1 year.

Results: A total of 136 participants were enrolled, and 69 allocated to palliative care (mean [SD], 55.1 [13.1] years) and 67 were randomized to usual care (mean [SD], 57.8 [14.7] years). Quality of life, as measured by a change in FACT-G score from enrollment to 12 weeks, was significantly higher in patients randomized to the intervention group, who demonstrated a mean (SD) increase of 5.91 (16.65) points compared with 1.08 (16.00) in controls (P = .03 using the nonparametric Wilcoxon test). Median estimates of survival were longer in the intervention group than the control group: 289 (95% CI, 128-453) days vs 132 (95% CI, 80-302) days, although this did not reach statistical significance (P = .20). There were no statistically significant differences in depression, admission to the intensive care unit, and discharge to hospice.

Conclusions and relevance: Emergency department-initiated palliative care consultation in advanced cancer improves quality of life in patients with advanced cancer and does not seem to shorten survival; the impact on health care utilization and depression is less clear and warrants further study.

Trial registration: clinicaltrials.gov Identifier: NCT01358110.

Figure 1.. Kaplan-Meier Estimates of Survival According to Study Group of 136 Patients

Survival was calculated from the time of enrollment to the time of death, if it occurred during the study period, or to the time of censoring of data. Median estimates of survival were 289 (95% CI, 128-453) days and 132 (95% CI, 80-302) days for the intervention and the usual care group, respectively. Tick marks indicate censoring of data. Shaded areas are 95% CIs.

Figure 2.. Mean Change in Quality-of-Life (QOL) Scores Among the Intervention and the Usual Care Groups, at 6 and 12 Weeks

Diamonds show the mean change, and error bars, the 95% CI. We assessed QOL with the use of the Functional Assessment of Chronic Illness Therapy–General Measure (FACT-G) scale, on which scores range from 0 to 108, with higher scores indicating a better QOL. Study group is the independent variable. Wilcoxon rank test showed a trend toward significant between group differences. Data are from 67 participants in the usual care group and 69 patients in the intervention group.

Figure 3.. Mood Assessment of Major Depressive Disorder (MDD) With Outcomes at Baseline, Week 6, and Week 12

Depressive symptoms indicating the presence of MDD were assessed with the use of the Patient Health Questionnaire 9 (PHQ-9), a 9-item measure that evaluates symptoms of major depressive disorder according to the criteria of the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Major depressive disorder was coded as a binary variable (yes/no). A major depressive disorder was noted as a Yes if a patient reported at least 5 of the 9 symptoms of depression on the PHQ-9, with 1 of the 5 symptoms being depressed mood or a lack of pleasure. Symptoms had to be present for more than half the time over the past 2 weeks, except for the symptom of suicidal thoughts, which was included in the notation of major depressive disorder, if it was present at any time. The percentages of patients with noted MDD mood symptoms at 3 different time points, assigned to intervention group, and those assigned to the usual care group are shown. The analyses were performed with an intention to treat, and we chose a conservative method of carrying baseline values forward to account for all missing data.