Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers (ENABLE CHF-PC): study protocol for a randomized controlled trial

Abstract

BackgroundPalliative care is specialized medical care for people with serious illness that is focused on providing relief from symptoms and stress and improving the quality of life (QOL) for patients and their families. To help the 6.5 million U.S. adults and families affected by heart failure manage the high symptom burden, complex decision-making, and risk of exacerbation and death, the early integration of palliative care is critical and has been recommended by numerous professional organizations. However, few trials have tested early outpatient community-based models of palliative care for patients diagnosed with advanced heart failure and their caregivers. To address this gap, through a series of formative evaluation trials, we translated an oncology early palliative care telehealth intervention for heart failure to create ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends, Comprehensive Heartcare for Patients and Caregivers).Methods/DesignThe primary objective of this multisite pragmatic randomized controlled trial is to test the efficacy of ENABLE CHF-PC plus usual heart failure care compared to usual care alone. Community-dwelling persons who are ≥50 years of age with New York Heart Association class III/IV or American Heart Association/American College of Cardiology stage C/D heart failure and their primary caregiver (if present) are being randomized to one of two study arms. The ENABLE CHF-PC intervention group receives usual heart failure care plus an in-person palliative care assessment by a board-certified palliative care provider (caregivers are invited to attend), a series of nurse coach-led, weekly psychoeducational 20 to 60 min phone sessions using a guidebook called Charting Your Course (patients: 6 sessions and caregivers: 4 sessions), and monthly check-in calls. Charting Your Course topical content includes problem-solving, coping, self-care and symptom management, communication, decision-making, advance care planning, and life review (patients only). Primary outcomes include patient QOL and mood (depressive symptoms/anxiety) and caregiver QOL, mood, and burden at 8 and 16 weeks after baseline. Outcomes will be examined using an intention-to-treat approach and mixed effects modeling for repeated measures.DiscussionThis trial will determine whether the ENABLE CHF-PC model of concurrent heart failure palliative care is superior to usual heart failure care alone in achieving higher patient and caregiver QOL, improving mood, and lowering burden.Trial registration ClinicalTrials.gov, NCT02505425. Registered on 22 July 2015.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2770-9) contains supplementary material, which is available to authorized users.

Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure

“…16 ENABLE CHF-P C is a nurse-led, predominantly telephone-based psychoeducational intervention for patients with advanced HF who are still months to years from the end of life. [17][18][19][20] The intervention is focused on teaching patients and family caregivers skills to help them cope with their serious illness (eg, problem solving, symptom and self-care management, communication, treatment and advance care decision-making, and life review). Quality of life (QOL) and mood were the primary outcomes of this single-blind randomized clinical trial comparing ENABLE CHF-PC with usual HF care.…”

The project ENABLE Cornerstone randomized pilot trial: Protocol for lay navigator-led early palliative care for African-American and rural advanced cancer family caregivers

“…The PI and a palliative care nurse practitioner study co-investigator (RAT) oversaw training of the lay navigator to deliver the intervention. The training program was approximately 70 h in length and was modeled on procedures developed by our study team over the course of several clinical trials of behavioral interventions [34,39]. The training consisted of independent readings, interactive online modules, videos including demonstration of coaching techniques (e.g., active listening, single and double-sided reflections), review of all study protocols and procedures, provision of the treatment manual, and role play of six simulated training cases.…”

Levosimendan Efficacy and Safety: 20 years of SIMDAX in Clinical Use

“…Investigations in this direction can be expected, although these are likely to be driven primarily by developments in telemedicine technologies, rather than by any focus on specific medical interventions. 150 A range of ICU situations has been identified in which levosimendan may offer clinical benefits, either as an adjunct to existing interventions or as an alternative to conventional therapies. These situations include haemodynamic support in cardiac critical care, 151 haemodynamic support in septic cardiomyopathy, 152,153 weaning from the ventilator, 154 weaning from venoarterial extracorporeal membrane oxygenation after cardiac surgery, [155][156][157][158][159] and renal failure and kidney protection in cardiorenal syndrome.…”