Early integration of palliative care did not significantly improve FACIT-PAL (MD 0.98; 95% CI -1.28 to 3.23) or KCCQ scores (MD -2.06; 95% CI -7.89 to 3.78) compared to standard care alone.
RCT (n=205)
Open-label
1:1
Yes
Does early integration of palliative care combined with standard cardiac care improve health status and mood in patients with non-terminal heart failure compared to standard cardiac care alone?
Early integration of palliative care did not provide additional benefits to health status or mood compared to optimized standard cardiac care alone in patients with non-terminal heart failure.
Mean Difference: 0.98 (95% CI -1.28–3.23)
p-value: p=0.40
BACKGROUND: Heart failure is a substantial global health concern that severely affects patients' quality of life. We aimed to compare the effects of early integration of palliative care (EIPC) and standard cardiac care on health status and mood of patients with non-terminal heart failure. METHODS: EPCHF was a multicentre, parallel, two-arm, open-label, randomised controlled trial carried out at University Hospital Bonn and University Hospital Düsseldorf in Germany. Eligible patients (aged 18 years or older) had heart failure, with New York Heart Association class II or more and NT-proBNP concentrations greater than or equal to 400 pg/mL. Patients were randomly assigned (1:1) to receive EIPC with standard cardiac care or standard cardiac care alone. Randomisation was computer-generated with allocation concealment, variable block sizes, and stratification by investigational site. The primary endpoints were health status and mood, measured every 3 months over 12 months using the Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-PAL) and the Kansas City Cardiomyopathy Questionnaire (KCCQ), analysed by intention to treat. This trial is registered with DRKS.de, DRKS00013922. FINDINGS: Between May 21, 2019, and Nov 15, 2021, 843 patients were assessed for eligibility, 205 of whom were enrolled (100 assigned to EIPC and 105 assigned to standard cardiac care). 143 (70%) patients were male and 62 (30%) were female. Over 12 months, both groups significantly improved in FACIT-PAL and KCCQ Overall Summary Score (OSS) with no significant differences between the groups (FACIT-PAL adjusted mean difference 0·98 points 95% CI -1·28 to 3·23; p=0·40; KCCQ-OSS adjusted mean difference -2·06 points -7·89 to 3·78; p=0·49). Nine (9%) patients in the EIPC group and seven (7%) patients in the standard cardiac care group died from any cause, with no significant differences in time to death between the two groups (hazard ratio HR 1·32 95% CI 0·49 to 3·54; p=0·58). 22 (22%) patients in the EIPC group and 21 (21%) patients in the standard cardiac care group were hospitalised at least once due to heart failure, with no significant differences in time to heart-failure-related hospitalisation between the two groups (HR 1·09 0·61 to 1·98; p=0·77). 70 (70%) patients in the EIPC group and 62 (59%) in the standard cardiac care group had any adverse events (p=0·10). INTERPRETATION: In this open-label, randomised clinical trial, standard cardiac care, featuring guideline-directed optimisation of medical therapy and regular 3-monthly follow-ups was found to be as effective as when combined with EIPC in improving health status and mood in patients with non-terminal heart failure. Future clinical practices should consider EIPC based on individual patient needs. FUNDING: Federal Ministry of Education and Research.
Balata et al. (2024) conducted an RCT in Heart failure (n=205). Early integration of palliative care (EIPC) vs. Standard cardiac care alone was evaluated on Health status and mood measured by FACIT-PAL and KCCQ (MD 0.98, 95% CI -1.28 to 3.23, p=0.40). Early integration of palliative care did not significantly improve FACIT-PAL (MD 0.98; 95% CI -1.28 to 3.23) or KCCQ scores (MD -2.06; 95% CI -7.89 to 3.78) compared to standard care alone.