ORLANDO (FRONTLINE MEDICAL NEWS) – Systematic introduction of palliative care interventions for patients with advanced heart failure improved patients’ quality of life and spurred their development of advanced-care preferences in a pair of independently performed, controlled, pilot studies.

But, despite demonstrating the ability of palliative-care interventions to help heart failure patients during their final months of life, the findings raised questions about the generalizability and reproducibility of palliative-care interventions that may depend on the skills and experience of the individual specialists who deliver the palliative care.

“The question is, can you take this intervention and standardize it so you could apply it to patients elsewhere with similar results,” wondered Joseph G. Rogers, MD , lead investigator for one of the studies. “I have a special group of people who work on this, and that’s why I don’t know if it is applicable to other centers. That’s why we are doing a multicenter trial with care providers at different skill levels using a well-defined protocol” Dr. Rogers said as he discussed his findings at the annual scientific meeting of the Heart Failure Society of America.

“Palliative care for patients with cardiovascular disease is in desperate need of good-quality evidence,” commented Larry A, Allen, MD , a heart failure cardiologist at the University of Colorado in Aurora and designated discussant for one of the two studies presented at the meeting. “We need large, randomized trials with clinical outcomes to look at patient outcomes from palliative-care interventions.”

The Palliative Care in Heart Failure ( PAL-HF ) trial, led by Dr. Rogers, enrolled 150 patients at a single center – Duke University in Durham, N.C. The patients primarily had diagnosed heart failure with any level of ejection fraction plus dyspnea at rest or minimal exertion, a hospitalization for heart failure during the past year, and a projected 50% risk for death during the next 6 months based on a standardized assessment. The researchers randomized patients to guideline-directed medical therapy alone or in combination with a palliative intervention delivered by an experienced nurse practitioner and a palliative-care physician who together addressed the patient’s symptoms, psychosocial and spiritual concerns, end-of-life preparation, and assessment of the goals of care.

The patients average 71 years old, about half were women, and about 40% were African Americans. They had been diagnosed with heart failure for an average of more than 5 years, all had advanced heart failure, about 60% spent at least half of their time awake immobilized in a bed or chair, and they had average NT-proBNP blood levels of greater than 10,000 pg/mL.

After 24 weeks of intervention, the palliative-care program produced both statistically significant and clinically meaningful improvements in two different measures of health-related quality of life, the Kansas City Cardiomyopathy Questionnaire ( KCCQ ) and the Functional Assessment of Chronic Illness Therapy – Palliative Care ( FACIT-PAL ). The KCCQ showed the palliative care intervention linked with an average rise of more than 9 points compared with patients in the control arm after adjustment for age and sex, a statistically significant increase on a scale where a 5-point rise is considered clinically meaningful. The FACIT-PAL showed an average, adjusted 11-point rise linked with the intervention, a statistically significant increase on a scale where an increase of at least 10 is judged clinically meaningful, reported Dr. Rogers, a heart failure cardiologist and professor of medicine at Duke University.

The palliative-care intervention also led to significant improvements in measures of spirituality, depression, and anxiety, but intervention had no impact on mortality.

“I like these endpoints and the idea that we can make quality-of-life better. These are very sick patients, with a predicted 6-month mortality of 50%. Patients reach a time when they don’t want to live longer but want better life quality for the days they still have,” he said in an interview.

The second report came from a single-center pilot study of 50 patients enrolled when they were hospitalized for acute decompensated heart failure and had at least one addition risk factor for poor prognosis such as age of at least 81 years, renal dysfunction, or a prior heart failure hospitalization within the past year. Patients randomized to the intervention arm underwent a structured evaluation based on the Serious Illness Conversation Guide and performed by a social worker experienced in palliative care and embedded in the heart failure clinical team. The primary endpoint of the SWAP-HF (Social Worker–Aided Palliative Care Intervention in High Risk Patients with Heart Failure) study was clinical-level documentation of advanced-care preferences by 6 months after the program began.

This outcome occurred in 65% of the 26 patients in the intervention arm and in 33% of the 24 patients in the control group, a statistically significant difference, reported Akshay S. Desai, MD , a heart failure cardiologist at Brigham and Women’s Hospital in Boston. In a secondary outcome, the palliative intervention also led to improved alignment between the patients’ understanding of their prognosis and their physicians’ opinions. After 6 months, good alignment existed for 94% of patients in the intervention group and for 26% of those in the control group.

“Although more comprehensive, multidisciplinary palliative care interventions may also be effective, the focused approach [used in this study] may represent a cost-effective and scalable method for shepherding limited specialty resources to enhance the delivery of patient-centered care,” Dr. Desai said. In other words, a program with a social worker costs less than a two-person staff with a palliative-care physician and nurse practitioner.

Despite its relative simplicity, the SWAP-HF intervention had some unique aspects that make it generalizability uncertain, commented Dr. Allen. The embedding of a social worker on the heart failure team placed a professional with a “good understanding of social context” right on the scene with everyone else delivering care to the heart failure patient, a good strategy for minimizing fragmentation, he said. In addition, the place where the study was done, Brigham and Women’s Hospital, “is not your average hospital,” he noted,

In addition, the timing of the intervention studied during hospitalization may be problematic. Clinicians need to “be careful about patients making long-term decisions” about their care while they are hospitalized, a time when patients can be “ill, confused, and scared.” He cited recent findings from a study of hospital-based palliative-care interventions for family members of patients with chronic critical illness that did not reduce anxiety or depression symptoms among the treated family members and may have increased symptoms of posttraumatic stress disorder ( JAMA. 2016 July 5;374[1]:51-62 ).

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