Implementing AI-assisted, patient-friendly imaging report summaries to enhance oncology care delivery: protocol for a randomized mixed-methods quality improvement study

Background: As required by the 21st Century Cures Act, all test results, including final radiology reports, are released to patients as soon as the results are finalized. However, radiology reports are primarily intended for communication between medical professionals and can often be difficult for patients to interpret, particularly in cancer care settings. We developed a tool that leverages a large language model (LLM; ChatGPT-5.2, OpenAI, San Francisco, CA) to draft a patient-friendly plain language version of imaging results (Patient-Friendly Scan Result Generation [PFSG] tool) that oncologists can incorporate into their communication with patients via patient portals. This article describes our mixed-methods study protocol. Objective: Our primary aims are to: 1) assess whether patients who receive patient-friendly versions of scan results report better understanding of their results than patients who do not; 2) assess whether introduction of the PFSG tool affects provider workload; and 3) explain how and under what circumstances the PFSG tool enhances communication and workflows, and affects patient and provider outcomes. Methods: We will use an embedded mixed-methods, prospective cohort design within a quality improvement (QI) initiative. The PFSG tool will be implemented using a modified three-wave staircase trial design, with providers in randomized cohorts of oncology disease groups progressively gaining access to the tool over the course of the study. Approximately 60 providers from 11 oncology disease focus groups will be randomized. Longitudinal provider outcomes will be measured through surveys at one month pre-implementation, one month post-implementation, and three months post-implementation. Patient outcomes will be measured cross-sectionally through surveys at one month pre-implementation (n=350) and at post-implementation result point-of-contact (n=350). Additionally, we will conduct interviews with patients and oncologists to inform the iterative design of the tool and its implementation. Results: This study was funded in September 2025 and data collection began in February 2026. As of September 2026, the PFSG tool has been rolled out to all oncology providers, with Cohort 3 post-implementation data collection beginning in August 2026. A total of 738 patient baseline surveys have been collected and patient post-implementation data collection is in progress. Conclusions: This is the protocol for a study of the implementation of a patient-friendly results tool in oncology provider workflows to facilitate improved communication of radiology results to oncology patients. The results of this study will lend evidence to the utility and acceptability of the study tool, and tools like it, to close an important oncology care gap. If the tool is shown to improve key oncology patient and provider outcomes, it may lead to development of a wider release for more general patient populations.