NCT06698640

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,821

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2026

Completed
3 months until next milestone

Results Posted

Study results publicly available

June 22, 2026

Completed
Last Updated

June 22, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

November 18, 2024

Results QC Date

March 17, 2026

Last Update Submit

May 22, 2026

Conditions

Keywords

gaps in carepreventive caretext messaging

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

OTHER

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.

Other: Traditional Passive Outreach

Automated SMS

ACTIVE COMPARATOR

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.

Behavioral: Automated SMS

Automated SMS + Conversational AI Scheduling Assistance

EXPERIMENTAL

Participants 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.

Behavioral: Automated SMS + Conversational AI Scheduling Assistance

Interventions

Automated SMSBEHAVIORAL

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.

Automated SMS

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.

Automated SMS + Conversational AI Scheduling Assistance

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.

Control

Eligibility Criteria

Age0 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (1)

Waymark

San Francisco, California, 94115, United States

Location

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

Locations