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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
70
The 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.
Participants 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.
Nationwide Children's Hospital
Columbus, Ohio, United States
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.
Time frame: 1 month post-baseline and 3 months post-baseline for Caregivers. Providers will complete this at baseline only.
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%.
Time frame: 1 month and 3 months post-baseline
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.
Time frame: Baseline and 3 months post-baseline
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%.
Time frame: Caregivers will complete at 3 months and 6 months post-baseline. Providers will complete at baseline and 6 months post-baseline.
Retention Rate
Percentage of participants completing follow-up assessments, measured as a percentage. Target ≥70%.
Time frame: 1 month, 3 months, and 6 months post-baseline
Social Determinants of Health
This questionnaire is a common instrument used in clinical settings to identify health-related social needs.
Time frame: Caregivers will complete at baseline, 3 months post-baseline, and 6 months post-baseline.
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.
Time frame: Continuous through 6 months post-baseline
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.
Time frame: Baseline and 6 months post-baseline
Caregiver Qualitative interview
Measured via qualitative themes. Caregivers will be interviewed about their perceptions of chatbot usability, acceptability, study procedures, and care experience.
Time frame: 3 months and 6 months post-baseline.
Technical Performance Metrics
Measurement of the accuracy of chatbot's responses as a percent from 0 (no accuracy) to 100 (always accurate). Target ≥70%
Time frame: Continuously throughout 6 months of study involvement.
Perceived Research Burden Assessment (PeRBA)
Survey measuring Caregiver burden related to study participation on a scale of 1 (most burden) to 5 (least burden). Target ≥4.
Time frame: 1 month, 3 months, and 6 months post-baseline.
Recruitment rate
Measurment as a percentage of total recruitment goal reached over time and dropout rate.
Time frame: Continuous throughout 6 months of study involvement.
Caregiver Quality of Life Survey
Survey measuring caregiver-reported quality of life changes on a scale of 1 (least satisfied) to 6 (most satisfied)
Time frame: Baseline, 3 months post-baseline, and 6 months post-baseline.
Caregiver Stress Inventory
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Survey measuring caregiver stress levels and contributors to stress over time. Survey is a series of statements and caregivers record how much they agree with the statement on a scale of 1 (strongly disagree) to 5 (strongly agree).
Time frame: Baseline, 3 months post-baseline, 6 months post-baseline.
Caregiver Self-Efficacy Scale
Survey measuring Caregiver levels of self-efficacy in managing care and navigating resources. Survey is a series of statements and caregivers record how much they agree with the statement on a scale of 1 (strongly disagree) to 5 (strongly agree).
Time frame: Baseline, 3 months, and 6 months post-baseline.
Resource Access Satisfaction Survey
Survey completed by a Caregiver measuring how likely they are to recommend the intervention to someone who needs help finding health and/or social resources on a scale of 1 (least likely) to 10 (most likely).
Time frame: 3 months and 6 months post-baseline.
Provider Qualitative Interview.
Health care providers will discuss their thoughts about using the app and offer opinions about the app and how it can improve.
Time frame: Baseline and 6 months post-baseline