Improving Time to Palliative Care Review With Predictive Modeling: Study Protocol for a Stepped-wedge, Pragmatic Randomized Controlled Trial

Abstract

\n Background: Palliative care is a medical specialty centered on improving the quality of life (QOL) of patients with complex or life-threatening illnesses. The need for Palliative care is increasing and with that the rigorous testing of triage tools that can be used quickly and reliably to identify patients that may benefit from palliative care. Methods: To that Aim we will conduct a two-armed stepped-wedge cluster randomized trial rolled out to two inpatient hospitals to evaluate whether a machine learning algorithm accurately identifies patients who may benefit from a comprehensive review by a palliative care specialist, and decreases time to receiving a palliative care consult in hospital. This is a single-center study which will be conducted from August 2019 to November 2020 at Saint Mary’s Hospital & Methodist Hospital, Mayo Clinic, Rochester, Minnesota. Clusters will be nursing units which will be chosen to be a mix of complex patients from Cardiology, Critical Care and Oncology and had previously established relationships with palliative medicine. The stepped wedge design will have 12 units allocated to a design matrix of 5 treatment wedges. Each wedge will last 75 days resulting in a study period of 12 months unless otherwise specified. Data will be analyzed with Bayesian hierarchical models with credible intervals denoting statistical significance.Discussion: This intervention offers a pragmatic approach to delivering specialty palliative care to hospital patients in need using machine learning, thereby leading to high value care and improved outcomes. It is not enough for AI to be utilized by simply publishing research showing predictive performance; Clinical trials demonstrating better outcomes are critically needed. Furthermore, the deployment of an AI algorithm is a complex process that requires multiple teams with varying skill sets. To evaluate a deployed AI, a pragmatic clinical trial can accommodate the difficulties of clinical practice whilst retaining scientific rigor.Trial registration NCT03976297 (ClinicalTrials.gov), registered on June 6, 2019 prior to trial start.