Caregiver Burden, Health Status, Child and Infant Care, Preventative Care Services, Primary Health Care and Access to Primary Care, Social Needs Status, Technology Use to Support Caregivers, Unmet Health-Related Social Needs and Access to Community Resources
Conditions
Keywords
Social Needs, Chatbot, Community Resources
Brief summary
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.
Interventions
BEHAVIORALDAPHNE Chatbot Intervention
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.
OTHERStandard HRSN Screening and Referral (Usual Care)
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.
Sponsors
Emre Sezgin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
(Caregivers): * 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 Inclusion Criteria (Primary Care Providers and Support Team Members): * Must be 18 years or older * Must be employed at Nationwide Children's Hospital
Exclusion criteria
\- Due to the intervention only being translated into English, non-English Speakers will be excluded from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) | 1 month post-baseline and 3 months post-baseline for Caregivers. Providers will complete this at baseline only. | 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) | 1 month and 3 months post-baseline | 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) | Caregivers will complete at 3 months and 6 months post-baseline. Providers will complete at baseline and 6 months post-baseline. | 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 | 1 month, 3 months, and 6 months post-baseline | Percentage of participants completing follow-up assessments, measured as a percentage. Target ≥70%. |
| Social Determinants of Health | Caregivers will complete at 3 months post-baseline and 6 months post-baseline. | This questionnaire is a common instrument used in clinical settings to identify health-related social needs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User Chatbot Engagement | Continuous through 6 months post-baseline | 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 | Baseline and 6 months post-baseline | 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 | 3 months and 6 months post-baseline. | Measured via qualitative themes. Caregivers will be interviewed about their perceptions of chatbot usability, acceptability, study procedures, and care experience. |
| Patient Comprehension Questionnaire (PCQ) | Baseline and 3 months post-baseline | 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. |
| Technical Performance Metrics | Continuously throughout 6 months of study involvement. | Measurement of the accuracy of chatbot's responses as a percent from 0 (no accuracy) to 100 (always accurate). Target ≥70% |
| Perceived Research Burden Assessment (PeRBA) | 1 month, 3 months, and 6 months post-baseline. | Survey measuring Caregiver burden related to study participation on a scale of 1 (most burden) to 5 (least burden). Target ≥4. |
| Recruitment rate | Continuous throughout 6 months of study involvement. | Measurment as a percentage of total recruitment goal reached over time and dropout rate. |
| Caregiver Quality of Life Survey | Baseline, 3 months post-baseline, and 6 months post-baseline. | Survey measuring caregiver-reported quality of life changes on a scale of 1 (least satisfied) to 6 (most satisfied) |
| Caregiver Stress Inventory | Baseline, 3 months post-baseline, 6 months post-baseline. | 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). |
| Caregiver Self-Efficacy Scale | Baseline, 3 months, and 6 months post-baseline. | 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). |
| Resource Access Satisfaction Survey | 3 months and 6 months post-baseline. | 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). |
| Provider Qualitative Interview. | Baseline and 6 months post-baseline | Health care providers will discuss their thoughts about using the app and offer opinions about the app and how it can improve. |
Countries
United States
Contacts
CONTACTEmre Sezgin, PhD
PRINCIPAL_INVESTIGATOREmre Sezgin, PhD
Nationwide Children's Hospital
Outcome results
None listed