Randomised clinical trial of an early palliative care intervention (SUPPORT) for patients with idiopathic pulmonary fibrosis (IPF) and their caregivers: protocol and key design considerations

Abstract

IntroductionIdiopathic pulmonary fibrosis (IPF), a progressive life-limiting lung disease affects approximately 128 000 newly diagnosed individuals in the USA annually. IPF, a disease of ageing associated with intense medical and financial burden, is expected to grow in incidence globally. Median survival from diagnosis is 3.8 years, and many of these patients succumb to a rapid death within 6 months. Despite the fatal prognosis, we have found that patients and caregivers often fail to understand the poor prognosis as the disease relentlessly progresses. Based on feedback from patients and families living with IPF, we developed the S-Symptom Management, U-Understanding the Disease, P-Pulmonary Rehabilitation, P-Palliative Care, O-Oxygen Therapy, R-Research Considerations and T-Transplantation (‘SUPPORT') intervention to increase knowledge of the disease, teach self-management strategies and facilitate preparedness with end of life (EOL) planning.MethodsThis study is a randomised trial to test the efficacy of SUPPORT intervention compared with routine care in patients with IPF and their caregivers delivered after three clinical visits. We are recruiting a cohort of 64 new IPF patient/caregiver dyads (32 for each dyad).ResultsThe trial will evaluate whether the SUPPORT intervention decreases stress, improves symptom burden, quality of life, preparedness and advance care planning for patients and caregivers, quality of dying and death for caregivers if the patient dies during the course of the study, as well as assess the impact of primary palliative care on healthcare resource use near the EOL.ConclusionBy increasing knowledge of the disease, teaching self-management strategies and facilitating preparedness with EOL planning, we will address a critical gap in the care of patients with IPF.Trial registration numberNCT02929017; Pre-results.

Marked deterioration in the quality of life of patients with idiopathic pulmonary fibrosis during the last two years of life

“…Integrated palliative care in IPF patients seems to lower respiratory-related emergency room visits and hospitalisations and may allow more patients to die at home [ 55 ]. In this study, 67% of patients died in hospital and 11% in intensive care, which is in line with earlier findings, implying the necessity of improvements in advanced care planning and palliative care of patients with IPF [ 55 , 59 ]. Our results provide insight into the most important needs of end-stage IPF patients and support the use of early-integrated palliative care, which should include symptom control beyond treatment for dyspnea and psychosocial support.…”

Comprehensive Care in Pulmonary Fibrosis

“…Different interventions and programs that would include the holistic therapeutic approach individually required for each patient could be tested. Currently, there is an ongoing clinical trial that measures the potential benefit of the combination of education, self-management training for most common and distressing symptoms, caring for caregiver, and planning for future and development of shared end-oflife goals (SUPPORT, NCT02929017) comparing with routine care in IPF 66 . The only inclusion criteria for patients recruitment was the confident diagnosis of IPF.…”

The Role of Palliative Care in Reducing Symptoms and Improving Quality of Life for Patients with Idiopathic Pulmonary Fibrosis: A Review

“…Participation at two specialty referral centers has been associated with improved psychological well-being, higher frequency of palliative care referral, and lower adjusted mortality [56,57]. An ongoing IPF clinical trial includes an intervention focused on disease information, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (i.e., face-toface, printed material, digital) delivered by a nurse interventionist [58]. In one specialty referral center in Canada, a multidisciplinary collaborative model to deliver early integrated palliative care led to improvement in dyspnea management, greater engagement in advance care planning, reduced end-of-life hospitalization, reduced hospital deaths, greater adherence to patient wishes for care and place of death, and improved patient and caregiver experience.…”