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临床试验/NCT06698640
NCT06698640已完成不适用

Optimization of HEDIS Gap Closure Strategies for Well-Child Visits: A Three-Arm Randomized Controlled Trial

Waymark1 个研究点 分布在 1 个国家目标入组 2,821 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,821
试验地点
1
主要终点
Number of Participants With Well-Child Visit Completion

研究概览

简要总结

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.

详细描述

Study Overview:

This three-arm randomized clinical trial evaluates whether conversational AI-powered text message outreach with appointment scheduling assistance improves well-child visit completion rates among Medicaid-enrolled children aged 0-21 years in Virginia compared with automated text messages alone or traditional passive outreach. Randomization occurred June 1, 2025. Interventions were delivered June 9-July 14, 2025. Outcomes were observed through December 31, 2025 via administrative claims.

Purpose of the Study:

The primary purpose of this study is to determine whether conversational AI-powered appointment scheduling assistance, delivered via text message, improves well-child visit completion rates in Medicaid-enrolled children compared with automated SMS reminders alone or traditional passive outreach.

A secondary purpose is to evaluate whether AI-facilitated scheduling reduces staff time per completed appointment relative to traditional care team scheduling.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
0 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Automated SMS + Conversational AI Scheduling Assistance (Behavioral)

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.

干预措施: Automated SMS (Behavioral)

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.

干预措施: Traditional Passive Outreach (Other)

结局指标

主要结局

Number of Participants With Well-Child Visit Completion

时间窗: Up to 7 months post-randomization (June 1 - December 31, 2025)

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

次要结局

  • 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)

研究者

发起方
Waymark
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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