Protocol for a pragmatic trial comparing navigator and automated virtual interventions for guaranteeing adherence to fecal immunochemical testing (NAVIGATE-FIT)

Background: Fecal immunochemical testing (FIT) - a non-invasive colorectal cancer (CRC) screening method offers an opportunity to bridge CRC screening gaps in underserved settings. The effectiveness of FIT as a screening tool, however, is limited by low return rates of stool samples. Patient navigation has been demonstrated to successfully improve FIT return rates in randomized trial settings, however, in real-world settings, navigation may not achieve the same impact due to resource constraints. Text-based reminders offer a low-cost alternative to patient navigation to facilitate FIT test returns. In the NAVIGATE-FIT project, we seek to use rapid randomized testing to compare a text-based intervention to patient navigation in a quality improvement effort assessing if a text-based reminder program is non-inferior to patient navigation to improve FIT return rates in a safety-net hospital system. Methods: We will randomize primary care patients (English- or Spanish-speaking) due for CRC screening at Boston Medical Center (BMC) with an unreturned FIT test (ordered 30-37 days prior) to either a text messaging system (Artera) or patient navigation. Artera is an artificial intelligence enabled system which has been programmed with conversation text flows to facilitate FIT test returns. The patient navigation arm will prioritize patients with overdue FIT tests for a navigation phone call the week of randomization. Outcomes will be assessed in accordance with the Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) framework, and the project has been powered based on the effectiveness outcome of percentage of patients with a completed FIT test within 30 days of randomization. We have selected a non-inferiority margin of 13% on the risk difference scale and anticipate 80% power with inclusion of 196 patients in each arm. Primary analysis will be intention-to-treat. The primary project goal is to generate local knowledge to select a strategy to improve screening at BMC. Conclusions: The NAVIGATE-FIT project is well-positioned to test the hypothesis that a conversational text-based reminder and follow-up system is non-inferior to the current usual care patient navigation system at BMC, a large, academic, urban, safety-net hospital, for improving return rates of FIT screening tests. This protocol can serve as a model to other health systems seeking to undertake randomized quality improvement projects.