Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC): A randomized clinical trial.

Abstract

12013 Background: Serious illness conversations (SICs) can improve quality of life and decrease intensive care utilization at the end of life for patients with cancer. Yet SIC rates for patients with cancer are low and sustainable strategies are needed to engage patients and oncology clinicians in SICs. Methods: This randomized controlled trial was conducted at a tertiary cancer center. Using a cancer treatment guideline program (Pathways), oncology subspecialists identified treatment decision points where patients have an average prognosis <1 year and they would recommend an SIC. We enrolled patients with breast, gastrointestinal, genitourinary, gynecologic, and thoracic cancers who reached these points and did not have SICs documented in the Advance Care Planning tab (ACP-SICs) of the electronic medical record in the previous 6 months. Patients were randomized to receive a patient nudge (a mailed letter encouraging discussion of their values and preferences with their oncologist; arm 1), a clinician nudge (emails sent to oncology clinicians encouraging an SIC the day prior to the clinic visit; arm 2), both nudges (arm 3), or no nudges (arm 4). The primary analysis compared ACP-SIC documentation 60 days post-randomization for the combined vs no-nudge arms (arm 3 vs 4) using a generalized estimating equation model with a logit link adjusted for disease center and prior clinician SIC training, clustered on oncologists. A pre-specified alternative primary outcome used natural language processing (NLP) to identify SICs in free text notes in the 6 months prior to randomization and 60 days after to evaluate the presence of an NLP- or ACP-SIC 60 days after randomization using the same model. Similarly-constructed Cox proportional hazards models were used to estimate time to SIC. Results: Among 1051 patients randomized (arm 1: 273, arm 2: 240, arm 3: 277, arm 4: 261), median age was 65 years (range: 25-94), 40% were male, 79% White, 52% had gastrointestinal and 20% breast cancers. The Table displays unadjusted ACP and NLP+SIC rates. In adjusted analyses, compared to patients in the no-nudge arm (arm 4), patients in the combined nudge arm (arm 3) had 79% higher odds of ACP-SIC at 60 days (odds ratio 1.79, 95% CI 1.11-2.88, p=0.02) and 59% higher odds of NLP+ACP-SIC at 60 days (odds ratio 1.59, 95% CI 1.14-2.22, p=0.006). Time to ACP-SIC was 59% faster in clinician nudge-containing arms than the no-nudge arm (adjusted HR 1.59, 95% CI 1.16-2.19, p=0.004). Conclusions: Clinician emails increased SICs within 60 days, whereas patient nudges were ineffective. NLP increased detection of SICs by 49.7%, demonstrating the importance of evaluating SICs in free-text notes in SIC interventions.Long-term analyses will evaluate the interventions’ impact on care delivery outcomes. Clinical trial information: NCT05629065 . Unadjusted SIC at 60 days. Arm 1: Patient 2: Clinician 3: Combined 4: None ACP, % 10.6 16.7 17.3 10.7 NLP+ACP, % 22.4 27.8 34.0 24.4