Dataset Information

Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial.

ABSTRACT: BACKGROUND:Advanced heart failure (HF) is characterized by high morbidity and mortality. Conventional therapy may not sufficiently reduce patient suffering and maximize quality of life. OBJECTIVES:The authors investigated whether an interdisciplinary palliative care intervention in addition to evidence-based HF care improves certain outcomes. METHODS:The authors randomized 150 patients with advanced HF between August 15, 2012, and June 25, 2015, to usual care (UC) (n = 75) or UC plus a palliative care intervention (UC + PAL) (n = 75) at a single center. Primary endpoints were 2 quality-of-life measurements, the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary and the Functional Assessment of Chronic Illness Therapy-Palliative Care scale (FACIT-Pal), assessed at 6 months. Secondary endpoints included assessments of depression and anxiety (measured via the Hospital Anxiety and Depression Scale [HADS]), spiritual well-being (measured via the FACIT-Spiritual Well-Being scale [FACIT-Sp]), hospitalizations, and mortality. RESULTS:Patients randomized to UC + PAL versus UC alone had clinically significant incremental improvement in KCCQ and FACIT-Pal scores from randomization to 6 months (KCCQ difference = 9.49 points, 95% confidence interval [CI]: 0.94 to 18.05, p = 0.030; FACIT-Pal difference = 11.77 points, 95% CI: 0.84 to 22.71, p = 0.035). Depression improved in UC + PAL patients (HADS-depression difference = -1.94 points; p = 0.020) versus UC-alone patients, with similar findings for anxiety (HADS-anxiety difference = -1.83 points; p = 0.048). Spiritual well-being was improved in UC + PAL versus UC-alone patients (FACIT-Sp difference = 3.98 points; p = 0.027). Randomization to UC + PAL did not affect rehospitalization or mortality. CONCLUSIONS:An interdisciplinary palliative care intervention in advanced HF patients showed consistently greater benefits in quality of life, anxiety, depression, and spiritual well-being compared with UC alone. (Palliative Care in Heart Failure [PAL-HF]; NCT01589601).

SUBMITTER: Rogers JG

PROVIDER: S-EPMC5664956 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial.

Rogers Joseph G JG Patel Chetan B CB Mentz Robert J RJ Granger Bradi B BB Steinhauser Karen E KE Fiuzat Mona M Adams Patricia A PA Speck Adam A Johnson Kimberly S KS Krishnamoorthy Arun A Yang Hongqiu H Anstrom Kevin J KJ Dodson Gwen C GC Taylor Donald H DH Kirchner Jerry L JL Mark Daniel B DB O'Connor Christopher M CM Tulsky James A JA

Journal of the American College of Cardiology 20170701 3

<h4>Background</h4>Advanced heart failure (HF) is characterized by high morbidity and mortality. Conventional therapy may not sufficiently reduce patient suffering and maximize quality of life.<h4>Objectives</h4>The authors investigated whether an interdisciplinary palliative care intervention in addition to evidence-based HF care improves certain outcomes.<h4>Methods</h4>The authors randomized 150 patients with advanced HF between August 15, 2012, and June 25, 2015, to usual care (UC) (n = 75) ...[more]

PMID: 28705314

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Project description:Importance:Palliative care considerations are typically introduced late in the disease trajectory of patients with advanced heart failure (HF), and access to specialty-level palliative care may be limited. Objective:To determine if early initiation of goals of care conversations by a palliative care-trained social worker would improve prognostic understanding, elicit advanced care preferences, and influence care plans for high-risk patients discharged after HF hospitalization. Design, Setting, and Participants:This prospective, randomized clinical trial of a social worker-led palliative care intervention vs usual care analyzed patients recently hospitalized for management of acute HF who had risk factors for poor prognosis. Analyses were conducted by intention to treat. Interventions:Key components of the social worker-led intervention included a structured evaluation of prognostic understanding, end-of-life preferences, symptom burden, and quality of life with routine review by a palliative care physician; communication of this information to treating clinicians; and longitudinal follow-up in the ambulatory setting. Main Outcomes and Measures:Percentage of patients with physician-level documentation of advanced care preferences and the degree of alignment between patient and cardiologist expectations of prognosis at 6 months. Results:The study population (N?=?50) had a mean (SD) age of 72 (11) years and had a mean (SD) left ventricular ejection fraction of 0.33 (13). Of 50 patients, 41 (82%) had been hospitalized more than once for HF management within 12 months of enrollment. At enrollment, treating physicians anticipated death within a year for 32 patients (64%), but 42 patients (84%) predicted their life expectancy to be longer than 5 years. At 6 months, more patients in the intervention group than in the control group had physician-level documentation of advanced care preferences in the electronic health record (17 [65%] vs 8 [33%]; ?2?=?5.1; P?=?.02). Surviving patients allocated to intervention were also more likely to revise their baseline prognostic assessment in a direction consistent with the physician's assessment (15 [94%] vs 4 [26%]; ?2?=?14.7; P?<?.001). Among the 31 survivors at 6 months, there was no measured difference between groups in depression, anxiety, or quality-of-life scores. Conclusions and Relevance:Patients at high risk for mortality from HF frequently overestimate their life expectancy. Without an adverse impact on quality of life, prognostic understanding and patient-physician communication regarding goals of care may be enhanced by a focused, social worker-led palliative care intervention that begins in the hospital and continues in the outpatient setting. Trial Registration:clinicaltrials.gov Identifier: NCT02805712.

Project description:BackgroundPalliative care improves quality of life in patients with heart failure. Whether men and women with heart failure derive similar benefit from palliative care interventions remains unknown.MethodsIn a secondary analysis of the PAL-HF trial (Palliative Care in Heart Failure), we analyzed differences in quality of life among men and women with heart failure and assessed for differential effects of the palliative care intervention by sex. Differences in clinical characteristics and quality-of-life metrics were compared between men and women at serial time points. The primary outcome was change in Kansas City Cardiomyopathy Questionnaire score between baseline and 24 weeks.ResultsAmong the 71 women and 79 men, there was a significant difference in baseline Kansas City Cardiomyopathy Questionnaire (24.5 versus 36.2, respectively; P=0.04) but not Functional Assessment of Chronic Illness Therapy-Palliative Care scale (115.7 versus 120.3; P=0.27) scores. Among those who received the palliative care intervention (33 women and 42 men), women's quality-of-life score remained lower than that of men after enrollment. Treated men's scores were significantly higher than those untreated (6-month Kansas City Cardiomyopathy Questionnaire, 68.0 [interquartile range, 52.6-85.7] versus 41.1[interquartile range, 32.0-78.3]; P=0.047), whereas the difference between treated and untreated women was not significantly different (P=0.39). Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men.ConclusionsIn the PAL-HF trial, women with heart failure experienced a greater symptom burden and poorer quality of life as compared with men. The change in treated men's Kansas City Cardiomyopathy Questionnaire score between baseline and 24 weeks was significantly higher than those untreated; this trend was not observed in women. Thus, there may be a sex disparity in response to palliative care intervention, suggesting that sex-specific approaches to palliative care may be needed to improve outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT0158960.

Project description:ImportanceHealth care services that support the hospital-to-home transition can improve outcomes in patients with heart failure (HF).ObjectiveTo test the effectiveness of the Patient-Centered Care Transitions in HF transitional care model in patients hospitalized for HF.Design, setting, and participantsStepped-wedge cluster randomized trial of 2494 adults hospitalized for HF across 10 hospitals in Ontario, Canada, from February 2015 to March 2016, with follow-up until November 2016.InterventionsHospitals were randomized to receive the intervention (n = 1104 patients), in which nurse-led self-care education, a structured hospital discharge summary, a family physician follow-up appointment less than 1 week after discharge, and, for high-risk patients, structured nurse homevisits and heart function clinic care were provided to patients, or usual care (n = 1390 patients), in which transitional care was left to the discretion of clinicians.Main outcomes and measuresPrimary outcomes were hierarchically ordered as composite all-cause readmission, emergency department (ED) visit, or death at 3 months; and composite all-cause readmission or ED visit at 30 days. Secondary outcomes were B-PREPARED score for discharge preparedness (range: 0 [most prepared] to 22 [least prepared]); the 3-Item Care Transitions Measure (CTM-3) for quality of transition (range: 0 [worst transition] to 100 [best transition]); the 5-level EQ-5D version (EQ-5D-5L) for quality of life (range: 0 [dead] to 1 [full health]); and quality-adjusted life-years (QALY; range: 0 [dead] to 0.5 [full health at 6 months]).ResultsAmong eligible patients, all 2494 (mean age, 77.7 years; 1258 [50.4%] women) completed the trial. There was no significant difference between the intervention and usual care groups in the first primary composite outcome (545 [49.4%] vs 698 [50.2%] events, respectively; hazard ratio [HR], 0.99 [95% CI, 0.83-1.19]) or in the second primary composite outcome (304 [27.5%] vs 408 [29.3%] events, respectively; HR, 0.93 [95% CI, 0.73-1.18]). There were significant differences between the intervention and usual care groups in the secondary outcomes of mean B-PREPARED score at 6 weeks (16.6 vs 13.9; difference, 2.65 [95% CI, 1.37-3.92]; P < .001); mean CTM-3 score at 6 weeks (76.5 vs 70.3; difference, 6.16 [95% CI, 0.90-11.43]; P = .02); and mean EQ-5D-5L score at 6 weeks (0.7 vs 0.7; difference, 0.06 [95% CI, 0.01 to 0.11]; P = .02) and 6 months (0.7 vs 0.6; difference, 0.06 [95% CI, 0.01-0.12]; P = .02). There was no significant difference in mean QALY between groups at 6 months (0.3 vs 0.3; difference, 0.00 [95% CI, -0.02 to 0.02]; P = .98).Conclusions and relevanceAmong patients with HF in Ontario, Canada, implementation of a patient-centered transitional care model compared with usual care did not improve a composite of clinical outcomes. Whether this type of intervention could be effective in other health care systems or locations would require further research.Trial registrationClinicalTrials.gov Identifier: NCT02112227.

Project description:ImportancePersistent congestion is associated with worse outcomes in acute heart failure (AHF). Mineralocorticoid receptor antagonists administered at high doses may relieve congestion, overcome diuretic resistance, and mitigate the effects of adverse neurohormonal activation in AHF.ObjectiveTo assess the effect of high-dose spironolactone and usual care on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels compared with usual care alone.Design, setting, and participantsThis double-blind and placebo (or low-dose)-controlled randomized clinical trial was conducted in 22 US acute care hospitals among patients with AHF who were previously receiving no or low-dose (12.5 mg or 25 mg daily) spironolactone and had NT-proBNP levels of 1000 pg/mL or more or B-type natriuretic peptide levels of 250 pg/mL or more, regardless of ejection fraction.InterventionsHigh-dose spironolactone (100 mg) vs placebo or 25 mg spironolactone (usual care) daily for 96 hours.Main outcomes and measuresThe primary end point was the change in NT-proBNP levels from baseline to 96 hours. Secondary end points included the clinical congestion score, dyspnea assessment, net urine output, and net weight change. Safety end points included hyperkalemia and changes in renal function.ResultsA total of 360 patients were randomized, of whom the median age was 65 years, 129 (36%) were women, 200 (55.5%) were white, 151 (42%) were black, 8 (2%) were Hispanic or Latino, 9 (2.5%) were of other race/ethnicity, and the median left ventricular ejection fraction was 34%. Baseline median (interquartile range) NT-proBNP levels were 4601 (2697-9596) pg/mL among the group treated with high-dose spironolactone and 3753 (1968-7633) pg/mL among the group who received usual care. There was no significant difference in the log NT-proBNP reduction between the 2 groups (-0.55 [95% CI, -0.92 to -0.18] with high-dose spironolactone and -0.49 [95% CI, -0.98 to -0.14] with usual care, P = .57). None of the secondary end point or day-30 all-cause mortality or heart failure hospitalization rate differed between the 2 groups. The changes in serum potassium and estimated glomerular filtration rate at 24, 48, 72, and 96 hours. were similar between the 2 groups.Conclusions and relevanceAdding treatment with high-dose spironolactone to usual care for patients with AHF for 96 hours was well tolerated but did not improve the primary or secondary efficacy end points.Trial registrationclinicaltrials.gov Identifier: NCT02235077.

Dataset Information

Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial.

Publications

Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial.

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