The goal of this clinical trial is to learn if the DAPHNE chatbot can improve caregiver engagement, usability, and integration of social care support tools into clinical workflows in caregivers of pediatric patients receiving care at the Nationwide Children's Hospital Primary Care Center (NCH PCC). This is a pilot randomized clinical trial.
The main questions it aims to answer are:
* Is the DAPHNE chatbot usable, acceptable, and minimally burdensome for caregivers over a 6-month period? * Can the DAPHNE chatbot be effectively integrated into primary care provider workflows?
Researchers will compare the DAPHNE chatbot intervention arm to the standard of care control arm to see if the intervention improves caregiver-reported outcomes and provider workflow integration.
Participants that are patients will be randomly assigned to either the DAPHNE chatbot group or the standard of care group. Complete surveys assessing usability, acceptability, and burden and participate in brief qualitative interviews to share feedback on their experience.
Participants that are Primary Care providers will discuss integration of DAPHNE into clinical workflows and complete workflow integration assessments.
Must be a caregiver of a child seen within the NCH primary care network who self-identifies with at least one unmet social need
Must be 18 years of age or older
Must be English-speaking
Must have a device that connects to the internet
None
Parallel
DAPHNE Chatbot Intervention
BehavioralThe DAPHNE intervention consists of a conversational, AI-powered chatbot designed to identify and address health-related social needs (HRSNs) among caregivers of pediatric patients. Delivered via a secure mobile and web-based application, the chatbot facilitates natural language interactions to assess needs, generate personalized resource recommendations, and support real-time navigation to community-based services. Participants assigned to the intervention arm will have continuous access to the chatbot over a six-month period, including automated nudges, tailored prompts, and context-aware suggestions. The intervention is non-invasive and participant-driven.
Standard HRSN Screening and Referral (Usual Care)
Other interventionParticipants randomized to the control group will receive the standard-of-care HRSN screening and referral services as currently implemented in Nationwide Children's Hospital Primary Care Clinics. These services include in-clinic social needs assessments conducted during routine visits and referrals to internal or external resources, such as social work or care coordination teams. Participants in this group will not receive access to the DAPHNE chatbot.
System Usability Scale (SUS)
Survey measuring the participant usability of the chatbot on a range of 0 (lowest usability) to 100 (highest usability). Target ≥68.
Web Evaluation Questionnaire (WEQ)
Survey measuring the Caregiver's acceptability of the chatbot on a scale of 0% (lowest acceptability) to 100% (highest acceptability). Target ≥80%.
Feasibility of Intervention Measure (FIM)
Survey measuring participant ratings of feasibility of the study implementation on a scale of 0% (least feasible) to 100% (most feasible). Target ≥80%.
Retention Rate
Percentage of participants completing follow-up assessments, measured as a percentage. Target ≥70%.
User Chatbot Engagement
Measured via a log that captures total minutes participants spent using the chatbot, total number of logins, session durations, screenings completed, and number of resources accessed.
Provider Workflow Integration Expectancy
Survey measuring Provider rating of ease of chatbot workflow integration on a scale of 1 (lowest ease of integration) to 5 (highest ease of integration). Target ≥4.
Caregiver Qualitative interview
Measured via qualitative themes. Caregivers will be interviewed about their perceptions of chatbot usability, acceptability, study procedures, and care experience.
Patient Comprehension Questionnaire (PCQ)
Survey measuring the Caregiver's comprehension of the chatbot prompts and recommendations on a scale of 1 (least comprehension) to 5 (most comprehension). Target ≥ 4.
Provider Survey on Standard of Care
Survey detailing providers pre-intervention standard workflows for addressing Health-Related Social Needs.
Electronic Health Record Review of Health-Related Social Needs (HRSN) Interventions
Frequency and types of HRSN interventions documented in Caregiver's EHR
Completed Health-Related Social Needs (HRSN) referrals.
Number of HRSN referrals completed by Caregiver (e.g., social services, specialty care).
Primary Care Visit Completion.
Percentage of completed primary care visits (i.e., Caregiver visit adherence).
Click on the lead sponsor to view all of their trials.
Emre Sezgin
Lead sponsor
Nationwide Children's Hospital
Sponsor institution
