Telemedicine Plus Standard Care Versus Standard Care Only in Specialized Outpatient Palliative Care: A Randomized Controlled Noninferiority Trial.

Abstract

Background: Patients suffering from incurable diseases are more likely to die in the hospital than at home. Specialized outpatient palliative care (PC) may be able to counteract this tendency. Similarly, potential benefits of telemedicine in health care were scientifically reported. The aim of this research was to compare patients receiving specialized outpatient PC plus telemedicine with those receiving standard specialized outpatient PC only. In this study, telemedicine is assumed to decrease the number of home visits and therefore should not be considered a mere add-on. Methods: This is a randomized controlled noninferiority trial. Recruitment lasted between January 2020 and October 2021. Quality of care was evaluated using the Integrated Palliative Care Outcome Scale (IPOS) at day 0, 7, and 14 after randomization. Change from day 0 to 7 was defined as the primary outcome (noninferiority margin = 4 points). This study was conducted in an urban setting in collaboration with a university hospital and a local specialized outpatient PC service. Results: A total of 196 patients were screened with 34 patients included (18 telemedicine/16 standard care). The mean change in the total score of the IPOS from day 0 to 7 amounted to -1.8 ± 3.9 (telemedicine) versus 1.2 ± 5.7 (standard care). The telemedicine group was statistically not relevantly inferior to the standard care group (t-test for noninferiority, p = 0.005). Conclusions: Although, due to COVID-19, the sample size remained rather small, our findings indicate that telemedical approaches offer a promising and equally effective option to provide specialized outpatient PC. Clinical Trial Registration Number: NCT06054048.