A Trial of AI-Powered Text Message Outreach on Well-Child Visit Completion
HEDIS
Optimization of HEDIS Gap Closure Strategies for Well-Child Visits: A Three-Arm Randomized Controlled Trial
1 other identifier
interventional
2,821
1 country
1
Brief Summary
The goal of this clinical trial is to evaluate whether conversational AI-powered text message outreach with appointment scheduling assistance improves well-child visit completion rates in Medicaid-enrolled children aged 0-21 years compared with automated text messages alone or traditional passive outreach. The main questions it aims to answer are: Does automated SMS outreach improve well-child visit completion rates compared to traditional passive outreach? Does conversational AI-powered scheduling assistance lead to higher completion rates than automated SMS alone? Researchers will compare three groups: Control Group: Participants receive traditional passive outreach (mailed reminders). Automated SMS Group: Participants receive standardized automated text message reminders. Automated SMS + Conversational AI Scheduling Assistance Group: Participants receive automated text messages plus AI-powered appointment scheduling assistance that contacts primary care providers directly to book appointments on behalf of families. Participants will: Be randomized into one of three study groups at the household level. Receive outreach from June 9-July 14, 2025. Have well-child visit completion ascertained through administrative claims through December 31, 2025. This study tests whether concrete scheduling support - rather than reminders alone - drives preventive care utilization in pediatric Medicaid populations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2024
CompletedFirst Posted
Study publicly available on registry
November 21, 2024
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2026
CompletedResults Posted
Study results publicly available
June 22, 2026
CompletedJune 22, 2026
May 1, 2026
7 months
November 18, 2024
March 17, 2026
May 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Well-Child Visit Completion
Binary indicator of whether each participant completed at least one well-child visit by December 31, 2025, ascertained through administrative claims using HEDIS technical specifications
Up to 7 months post-randomization (June 1 - December 31, 2025)
Secondary Outcomes (2)
Staff Time Per Successfully Scheduled Appointment
Up to 7 months post-randomization (June 1 - December 31, 2025)
Human Escalation Rate for Automated Scheduling Attempts
Up to 2 weeks from initiation of first automated scheduling attempt
Study Arms (3)
Control
OTHERParticipants received standard health plan outreach consisting of periodic mailed reminders. Families retained access to all standard appointment scheduling methods including telephone calls to provider offices.
Automated SMS
ACTIVE COMPARATORParticipants received standardized automated text message reminders at predetermined intervals (initial contact, 2-week follow-up, 4-week follow-up). Messages provided general information about visit importance and instructions to call providers to schedule. Messages did not include interactive scheduling or conversational capabilities.
Automated SMS + Conversational AI Scheduling Assistance
EXPERIMENTALParticipants received automated text message reminders with response options. When families expressed interest, structured follow-up texts collected appointment preferences (preferred dates, times, locations, number of children needing visits). An AI-powered telephone scheduling system (GPT-4o, OpenAI) then contacted the child's primary care provider directly to book appointments on behalf of families. The system disclosed its automated nature at call initiation and escalated to human staff when clinic policies were incompatible with automated scheduling or technical failures occurred.
Interventions
Participants received standardized automated text message reminders at predetermined intervals (initial contact, 2-week follow-up, 4-week follow-up). Messages provided general information about visit importance and instructions to call providers to schedule. Messages did not include interactive scheduling or conversational capabilities.
Participants received automated text message reminders with response options. When families expressed interest, structured follow-up texts collected appointment preferences. An AI-powered telephone scheduling system (GPT-4o, OpenAI) then contacted the child's primary care provider directly to book appointments on behalf of families. The system disclosed its automated nature at call initiation and escalated to human staff when clinic policies were incompatible with automated scheduling or technical failures occurred.
Participants received standard health plan outreach consisting of periodic mailed reminders. Families retained access to all standard appointment scheduling methods including telephone calls to provider offices.
Eligibility Criteria
You may qualify if:
- Medicaid beneficiary aged 0-21 years
- Had not completed a well-child visit in 2025
- Enrolled through the managed care organization with authorization for health plan outreach
- Valid mobile phone number capable of receiving SMS
You may not qualify if:
- Do-not-contact designation
- Inactive phone service
- Documented request for no contact from healthcare provider or health plan
- Prior SMS well-child visit outreach earlier in the 2025 measurement year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Waymarklead
Study Sites (1)
Waymark
San Francisco, California, 94115, United States
Limitations and Caveats
Single managed care organization setting in Virginia limits generalizability of effect estimates to other states, provider networks, or HEDIS bonus structures. English-only delivery may have excluded linguistically diverse families. Participants and clinical staff were not blinded. Six-month follow-up may not capture longer-term effects. Visit completion was a binary HEDIS indicator and does not reflect visit quality.
Results Point of Contact
- Title
- Sanjay Basu, MD PhD
- Organization
- Waymark
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2024
First Posted
November 21, 2024
Study Start
June 1, 2025
Primary Completion
December 31, 2025
Study Completion
March 17, 2026
Last Updated
June 22, 2026
Results First Posted
June 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share