Objective We conducted usability sessions with publicly insured pregnant individuals living with type 2 diabetes (T2D) and unmet social needs, and their care team members to assess: (1) interface usability, (2) user experience, and (3) clinical workflow integration facets of a high-fidelity prototype of our multi-component digital solution to refine user specifications for the randomized controlled trial (RCT). Methods Five patients and eight care team members from a tertiary Diabetes in Pregnancy Program participated between March and July 2023. Data collection included think-aloud sessions, empathy mapping, and semi-structured discussions guided by the double diamond framework. Transcripts were coded by four researchers, with saturation assessed across participants. Personas were created grounded in Social Cognitive Theory. Usability feedback was synthesized using affinity diagramming and IBM prioritization matrices. We conducted a reference-based validation study in which care members addressed persona-driven scenarios; proficiency, efficiency, and concordance with expert recommendations were calculated to identify areas for refinement. Results We identified 21 desired mHealth and six dashboard topics. The top three mHealth topic frequencies were personalized prompts (85%), learning card content (62%), and glucose tracking (62%). The top three dashboard topics were prioritized clinical and social needs pathways (63%), social needs risk levels (50%), and glucose tracking (50%). Three personas emerged: (1) “hands off,” (2) “overwhelmed but trying,” and (3) “engaged.” In the validation study, concordance varied: goal setting showed 100% concordance, while social needs referrals had the highest discordance (60%). Average proficiency and efficiency scores across scenarios were 40% and 37%, respectively, with the lowest agreement for “engaged” persona scenarios. Conclusion Patients and care team members identified highly valued and implementation-challenging features using our prototypes. The personas highlighted distinct engagement needs, and validation results underscored variability in concordance for social needs management. These findings inform pre-RCT refinements of the digital solution.
Fareed et al. (Sun,) studied this question.