Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness

Abstract

IntroductionEmergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysisThis is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m2, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.Ethics and disseminationInstitutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.Trial registration number NCT03325985; Pre-results.

Development and protocol for a nurse-led telephonic palliative care program

“…The nurse-led telephonic palliative care program is part of the Emergency Medicine Palliative Care Access research study, a large Patient-Centered Outcomes Research Institute-funded randomized control trial comparing facilitated, outpatient specialty palliative care to nurse-led telephonic palliative care delivery after an ED visit ( Grudzen et al, 2019 ). While the telephonic program is part of the larger trial, it operates as a pragmatic clinical initiative and not a strictly protocolized research intervention.…”

Barriers to recruitment into a randomized controlled trial comparing two modes of emergency department-initiated palliative care&nbsp;

“…Additional study details can be found in the published protocol paper. 16 The study was submitted to and approved by the NYU School of Medicine Institutional Review Board Ethics Committee.…”

Past, present, and future of palliative care in emergency medicine in the USA

“…Using Centers for Medicare and Medicaid Services data, the primary outcomes in approximately 300,000 patients will be assessed: ED disposition to an acute care setting, health‐care utilization in the 6 months following the ED visit, and survival following the index ED visit. This trial is scheduled to complete in 2022 Emergency Medicine Palliative Care Access (EMPallA): A prior randomized clinical trial found that ED‐initiated, inpatient palliative care consultation in advanced cancer improves quality of life and does not seem to shorten survival in patients with advanced cancer.…”