Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial.

CONTEXT: There are few randomized controlled trials on the effectiveness of palliative care interventions to improve the care of patients with advanced cancer. OBJECTIVE: To determine the effect of a nursing-led intervention on quality of life, symptom intensity, mood, and resource use in patients with advanced cancer. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial conducted from November 2003 through May 2008 of 322 patients with advanced cancer in a rural, National Cancer Institute-designated comprehensive cancer center in New Hampshire and affiliated outreach clinics and a VA medical center in Vermont. INTERVENTIONS: A multicomponent, psychoeducational intervention (Project ENABLE [Educate, Nurture, Advise, Before Life Ends]) conducted by advanced practice nurses consisting of 4 weekly educational sessions and monthly follow-up sessions until death or study completion (n = 161) vs usual care (n = 161). MAIN OUTCOME MEASURES: Quality of life was measured by the Functional Assessment of Chronic Illness Therapy for Palliative Care (score range, 0-184). Symptom intensity was measured by the Edmonton Symptom Assessment Scale (score range, 0-900). Mood was measured by the Center for Epidemiological Studies Depression Scale (range, 0-60). These measures were assessed at baseline, 1 month, and every 3 months until death or study completion. Intensity of service was measured as the number of days in the hospital and in the intensive care unit (ICU) and the number of emergency department visits recorded in the electronic medical record. RESULTS: A total of 322 participants with cancer of the gastrointestinal tract (41%; 67 in the usual care group vs 66 in the intervention group), lung (36%; 58 vs 59), genitourinary tract (12%; 20 vs 19), and breast (10%; 16 vs 17) were randomized. The estimated treatment effects (intervention minus usual care) for all participants were a mean (SE) of 4.6 (2) for quality of life (P = .02), -27.8 (15) for symptom intensity (P = .06), and -1.8 (0.81) for depressed mood (P = .02). The estimated treatment effects in participants who died during the study were a mean (SE) of 8.6 (3.6) for quality of life (P = .02), -24.2 (20.5) for symptom intensity (P = .24), and -2.7 (1.2) for depressed mood (P = .03). Intensity of service did not differ between the 2 groups. CONCLUSION: Compared with participants receiving usual oncology care, those receiving a nurse-led, palliative care-focused intervention addressing physical, psychosocial, and care coordination provided concurrently with oncology care had higher scores for quality of life and mood, but did not have improvements in symptom intensity scores or reduced days in the hospital or ICU or emergency department visits. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00253383.

The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions.

OBJECTIVE: There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues. METHODS: Half of the participants recruited from our rural U.S. comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, quality of life, mood, and functional status were assessed every 3 months until death. RESULTS: Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and "usual care" control group contamination are described. SIGNIFICANCE OF RESULTS: It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.

Has there been any progress in improving the quality of hospitalised death? Replication of a US chart audit study.

OBJECTIVE: To describe the experience of dying in a US tertiary academic medical centre and to compare this experience with a historical decedent sample. DESIGN: A retrospective, observational, chart audit study of adults (N=159) who died in hospital. SETTING: Component hospitals of the Dartmouth-Hitchcock Medical Center: Mary Hitchcock Memorial Hospital (MHMH), Lebanon, New Hampshire, and the affiliated Veteran's Affairs Medical Center (VAMC), White River Junction, Vermont. PARTICIPANTS: 159 hospitalised adult decedents comprising a random sample of 100 MHMH decedents and a total sample of 59 VAMC decedents. METHODS: The authors compared end-of-life (EOL) care in decedents who had a palliative care consultation (PCC) with those who did not. An exploratory analysis compared the EOL care between the 2008 decedent sample and an historical decedent sample (N=104). RESULTS: 63 of 159 inpatients received a PCC. Decedents receiving a PCC were less likely to die in an intensive care unit, had fewer invasive interventions (eg, intubation, assisted ventilation, dialysis, chemotherapy) and were more likely to have advance directives, do-not-resuscitate orders and comfort measures orders than those who did not receive a PCC. Higher rates of emotional and pastoral care were also noted. Compared with the historical sample, 2008 decedents had a higher rate of invasive interventions, but fewer invasive interventions were noted in the 2008 PCC subsample. CONCLUSIONS: Less invasive EOL care was observed in decedents who received a PCC. Ongoing monitoring of EOL care is critically important for hospital quality improvement programmes.

Proxy perspectives regarding end-of-life care for persons with cancer.

BACKGROUND: Each year, greater than a half million people die of cancer in the U.S. Despite progress in increasing access to palliative oncology services, end-of-life care still needs improvement. Measuring the quality of the end-of-life experience is difficult because of patient debility and reduced consciousness as death approaches. Family proxies have been proposed as valuable informants regarding the quality of end-of-life care. This article describes family proxy perspectives concerning care at the end of life in patients who died of advanced cancer. METHODS: In the context of a novel outpatient palliative care demonstration project, 125 family proxy respondents completed a structured survey by telephone 3 months to 6 months after the patient's death from breast, lung, or gastrointestinal cancer. Four key quality of care indicators were measured: decision-making and physician communication, location of death, hospice involvement, and end-of-life symptoms. RESULTS: Proxies reported that 78% to 81% of patients completed at least 1 form of advance directive and approximately half of them were helpful in guiding care. Communication with physicians regarding end-of-life treatment wishes occurred in 67% of cases, but only 57% of the patients actually made a plan with their physician to ensure that their wishes were followed. The majority of patients died in their location of choice, most often at home, and greater than half had hospice involvement for an average of 41.8 days before death. During the last week of life, the majority of patients experienced troublesome physical and emotional symptoms. CONCLUSIONS: Measurement of proxy perspectives is feasible as an indicator of the quality of end-of-life care, and the results of the current study provide actionable data for areas of improvement in palliative oncology care.