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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chatbot Access | Experimental | The intervention consists of a conversational, AI-powered chatbot designed to identify and address health-related social needs (HRSN) 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 6-month period, including automated messages, tailored prompts, and context-aware suggestions. The intervention is non-invasive and participant driven. |
|
| Standard of Care | Active Comparator | Participants randomized to the control group will receive the standard of care health-related social needs (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. Study-related surveys and outcome assessments will be equivalent across both groups. |
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| Health Care Providers | Experimental | All health care providers will receive access to the chatbot. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAPHNE Chatbot Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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%. | 1 month 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%. | 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%. | 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. | Caregivers will complete at 3 months post-baseline and 6 months post-baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Continuous through 6 months post-baseline |
| Provider Workflow Integration Expectancy |
| Measure | Description | Time Frame |
|---|---|---|
| Provider Survey on Standard of Care | Survey detailing providers pre-intervention standard workflows for addressing Health-Related Social Needs. | Baseline and 6 months post-baseline. |
| Electronic Health Record Review of Health-Related Social Needs (HRSN) Interventions |
Inclusion Criteria (Caregivers):
Inclusion Criteria (Primary Care Providers and Support Team Members):
Exclusion Criteria:
- Due to the intervention only being translated into English, non-English Speakers will be excluded from this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emre Sezgin, PhD | Contact | (614) 722-3179 | Emre.Sezgin@nationwidechildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Emre Sezgin, PhD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42008466 | Derived | Sezgin E, Clarkson E, Logan F, Jackson DI, Hussain SA, Stokes J, Bunger A, Brock G, Fosler-Lussier E, Kemper AR, Pai AL. An AI-based chatbot to support health-related social needs among pediatric primary care population: Protocol for a pilot randomized controlled trial. PLoS One. 2026 Apr 20;21(4):e0337868. doi: 10.1371/journal.pone.0337868. eCollection 2026. | |
| 41332826 |
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| Standard HRSN Screening and Referral (Usual Care) | Other | 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. |
|
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. |
| 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. | 3 months and 6 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. | Baseline and 3 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% | 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. | 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. | 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) | Baseline, 3 months post-baseline, and 6 months post-baseline. |
| Caregiver Stress Inventory | 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). | 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). | 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). | 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. | Baseline and 6 months post-baseline |
Frequency and types of HRSN interventions documented in Caregiver's EHR |
| 3 months and 6 months post-baseline |
| Completed Health-Related Social Needs (HRSN) referrals. | Number of HRSN referrals completed by Caregiver (e.g., social services, specialty care). | 3 months and 6 months post-baseline |
| Primary Care Visit Completion. | Percentage of completed primary care visits (i.e., Caregiver visit adherence). | 3 months and 6 months post-baseline |
| Missed Appointments | Number of caregiver missed/no-show clinic visits | 3 months and 6 months post-baseline. |
| Emergency Department Visits | Number of Emergency Department Visits per Caregiver | 3 months and 6 months post-baseline |
| Healthcare Cost Avoidance | Estimated cost avoidance from improved visit adherence and reduced ED utilization. Reported by Caregivers in USD. | 3 months and 6 months post-baseline |
| Sezgin E, Clarkson E, Logan F, Jackson DI, Hussain SA, Stokes J, Bunger A, Brock G, Fosler-Lussier E, Kemper AR, Pai AL. An AI-Based Chatbot to Support Health-Related Social Needs among Pediatric Primary Care Population: Protocol for a Pilot Randomized Controlled Trial. medRxiv [Preprint]. 2025 Nov 19:2025.11.17.25340433. doi: 10.1101/2025.11.17.25340433. |
| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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