Results from a racially diverse clinical trial show that despite bringing palliative care to rural and minority populations with heart failure facing hurdles to accessing such care, using telehealth delivery methods to improve access does not improve the mood or quality of life of patients or their caregivers.
Results from a racially diverse, single-blind, randomized clinical trial show that despite using telehealth delivery methods to bring palliative care to rural and minority populations, who shoulder a greater burden of heart failure, improving access to such care does not improve the mood or quality of life (QOL) of patients or their caregivers, reports JAMA Internal Medicine. The authors took up this study to address the dearth of culturally based models of palliative care in heart failure that specifically address the needs of these populations, as they often face hurdles when it comes to accessing adequate health care.
The study compared outcomes between 2 groups:
The primary outcome of QOL was measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Functional Assessment of Chronic Illness Therapy—Palliative-14 (FACIT-Pal-14); the primary outcome of mood over 16 weeks utilized the Hospital Anxiety and Depression Scale (HADS); and the secondary outcomes of global health, pain, and resource use used Patient Reported Outcome Measurement System Global Health, Patient Reported Outcome Measurement System Pain Intensity and Interference, and hospital days and emergency department visits, respectively.
All of the patients in the study, which took place between October 1, 2015, and May 31, 2019, had New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure and presented at University of Alabama at Birmingham or Birmingham Veterans Affairs Medical Center. Their mean (SD) age was 63.8 (8.5) years, most (54.5%) were African American, over a quarter (26.0%) lived in a rural area, and close to half (45.8%) had a high school education or less.
Results show that the mean (SD) baseline KCCQ score was 52.6 (21.0), but this had only improved by a mean (SE) 3.9 (1.3) and 2.3 (1.2) (difference, 1.6 [1.7]; d = 0.07; 95% CI, −0.09 to 0.24) points for the intervention and usual care groups respectively, by week 16, the authors report.
The mean (SD) baseline FACIT-Pal-14 score of 36.4 (9.5) barely improved as well: the ENABLE CHF-PC group saw a scant 1.4 (0.6) improvement vs 0.2 (0.5) (difference, 1.2 [0.8]; d = 0.12; 95% CI, −0.03 to 0.28) for the usual care group.
Evaluating mood change at 16 weeks did not produce any relevant difference for either group in the HADS-anxiety (d = −0.02; 95% CI, —0.20 to 0.16) or HADS-depression measures (d = —0.09; 95% CI, –0.24 to 0.06). The mean (SD) baseline scores here were 6.7 (3.6) and 5.7 (4.3), respectively, which indicate low levels of anxiety and depression.
Possible reasons for why the ENABLE CHF-PC intervention did not produce any meaningful results include that among the intervention group, almost half could not make their initial in-person consultation while 39% failed to complete the 6 nurse-led telephone session. An additional reason from the study authors include that the good baseline KCCQ and FACIT-Pal-14 scores indicate existing good QOL and high functional status.
Meanwhile, a commentary on the study results points to how advancements in heart failure treatment are outpacing those in palliative care, so that the measures of improvement the authors evaluated were not accurate measures of patient needs for palliative care. Palliative care needs to be more dynamic, Nathan Goldstein, MD, from the Icahn School of Medicine at Mount Sinai in New York, noted.
“This trial raises a key question about the likely influence of baseline QOL as a key element in determining which populations might show the greatest benefit from the scarce palliative care specialty resource,” the authors conclude. “Future analyses and studies will examine both the patient factors and intervention components to find the right palliative care dose, for the right patient, at the right time.”
Bakitas MA, Dionne-Odom N, Ejem DE, et al. Effect of an early palliative care telehealth intervention vs usual care on patients with heart failure: the ENABLE CHF-PC randomized clinical trial. JAMA Intern Med. Published online July 27, 2020. doi:10.1001/jamainternmed.2020.2861