Developing a Framework and Electronic Tool for Communicating Diagnostic Uncertainty in Primary Care: A Qualitative Study.

Importance: Communication of information has emerged as a critical component of diagnostic quality. Communication of diagnostic uncertainty represents a key but inadequately examined element of diagnosis. Objective: To identify key elements facilitating understanding and managing diagnostic uncertainty, examine optimal ways to convey uncertainty to patients, and develop and test a novel tool to communicate diagnostic uncertainty in actual clinical encounters. Design, Setting, and Participants: A 5-stage qualitative study was performed between July 2018 and April 2020, at an academic primary care clinic in Boston, Massachusetts, with a convenience sample of 24 primary care physicians (PCPs), 40 patients, and 5 informatics and quality/safety experts. First, a literature review and panel discussion with PCPs were conducted and 4 clinical vignettes of typical diagnostic uncertainty scenarios were developed. Second, these scenarios were tested during think-aloud simulated encounters with expert PCPs to iteratively draft a patient leaflet and a clinician guide. Third, the leaflet content was evaluated with 3 patient focus groups. Fourth, additional feedback was obtained from PCPs and informatics experts to iteratively redesign the leaflet content and workflow. Fifth, the refined leaflet was integrated into an electronic health record voice-enabled dictation template that was tested by 2 PCPs during 15 patient encounters for new diagnostic problems. Data were thematically analyzed using qualitative analysis software. Main Outcomes and Measures: Perceptions and testing of content, feasibility, usability, and satisfaction with a prototype tool for communicating diagnostic uncertainty to patients. Results: Overall, 69 participants were interviewed. A clinician guide and a diagnostic uncertainty communication tool were developed based on the PCP interviews and patient feedback. The optimal tool requirements included 6 key domains: most likely diagnosis, follow-up plan, test limitations, expected improvement, contact information, and space for patient input. Patient feedback on the leaflet was iteratively incorporated into 4 successive versions, culminating in a successfully piloted prototype tool as an end-of-visit voice recognition dictation template with high levels of patient satisfaction for 15 patients with whom the tool was tested. Conclusions and Relevance: In this qualitative study, a diagnostic uncertainty communication tool was successfully designed and implemented during clinical encounters. The tool demonstrated good workflow integration and patient satisfaction.