Effect of an Artificial Intelligence Decision Support Tool on Palliative Care Referral in Hospitalized Patients: A Randomized Clinical Trial.

CONTEXT: Palliative care services are commonly provided to hospitalized patients, but accurately predicting who needs them remains a challenge. OBJECTIVES: To assess the effectiveness on clinical outcomes of an artificial intelligence (AI)/machine learning (ML) decision support tool for predicting patient need for palliative care services in the hospital. METHODS: The study design was a pragmatic, cluster-randomized, stepped-wedge clinical trial in 12 nursing units at two hospitals over a 15-month period between August 19, 2019, and November 17, 2020. Eligible patients were randomly assigned to either a medical service consultation recommendation triggered by an AI/ML tool predicting the need for palliative care services or usual care. The primary outcome was palliative care consultation note. Secondary outcomes included: hospital readmissions, length of stay, transfer to intensive care and palliative care consultation note by unit. RESULTS: A total of 3183 patient hospitalizations were enrolled. Of eligible patients, A total of 2544 patients were randomized to the decision support tool (1212; 48%) and usual care (1332; 52%). Of these, 1717 patients (67%) were retained for analyses. Patients randomized to the intervention had a statistically significant higher incidence rate of palliative care consultation compared to the control group (IRR, 1.44 [95% CI, 1.11-1.92]). Exploratory evidence suggested that the decision support tool group reduced 60-day and 90-day hospital readmissions (OR, 0.75 [95% CI, 0.57, 0.97]) and (OR, 0.72 [95% CI, 0.55-0.93]) respectively. CONCLUSION: A decision support tool integrated into palliative care practice and leveraging AI/ML demonstrated an increased palliative care consultation rate among hospitalized patients and reductions in hospitalizations.

Improving time to palliative care review with predictive modeling in an inpatient adult population: study protocol for a stepped-wedge, pragmatic randomized controlled trial.

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 both within Mayo Clinic Rochester in 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 of recruitment 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 while retaining scientific rigor. TRIAL REGISTRATION: ClinicalTrials.gov NCT03976297 . Registered on 6 June 2019, prior to trial start.