Abstract
BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a fatal disease that results in poor quality of life due to progressive respiratory symptoms, anxiety, and depression. Palliative care improves quality of life and survival in other progressive diseases. No randomized controlled trials have investigated the impact of palliative care on quality of life, anxiety, or depression in IPF. METHODS: We conducted a randomized, controlled, pilot study to assess the feasibility of measuring the effect of a palliative care clinic referral on quality of life, anxiety, and depression in IPF. Patients were randomized to usual care (UC) or usual care + palliative care (UC + PC) with routine pulmonary follow up at 3 and 6 months. The UC + PC group received a minimum of one PC clinic visit. Primary outcome was change from baseline in quality of life, anxiety, and depression as measured by the St. George's Respiratory Questionnaire (SGRQ), the Hospital Anxiety and Depression Index (HADS), and the Patient Health Questionnaire (PHQ-9) at 6 months. RESULTS: Twenty-two patients were randomized between September 2017 through July 2018; 11 to UC and 11 to UC + PC. There was no difference in the change in SGRQ score at 3 months or 6 months, however, the symptom score trended towards a significant worsening for UC + PC at both 3 and 6 months (mean change at 3 months for UC and UC + PC was - 7.8 and + 10.7, respectively, p = 0.066; mean change at 6 months for UC and UC + PC was - 6.0 and + 4.6, respectively, p = 0.055). There was no difference in the change in HADS anxiety or depression scores. There was a significant transient worsening in PHQ-9 scores for UC + PC at 3 months (UC: -1.6, UC + PC: + 0.9, p = 0.008); this effect did not persist at 6 months. CONCLUSION: This pilot study demonstrated that a randomized controlled trial of palliative care in idiopathic pulmonary fibrosis patients is feasible. Receiving palliative care did not lead to improved quality of life, anxiety, or depression compared to usual care after 6 months. Patients in the UC + PC group trended towards worsening symptoms and a small but statistically significant transient worsening in depression. These findings should be interpreted with caution, and need to be evaluated in adequately powered clinical trials. NCT03981406, June 10, 2019, retrospectively registered.