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临床试验/NCT06686849
NCT06686849已完成不适用

Comparing Technological and Relational Approaches to Support Families After a Missed Well Child Visit

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 3,846 人开始时间: 2025年1月9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
入组人数
3,846
试验地点
2
主要终点
Proportion of Patients of All Ages with any Completed Well-Child Visits

研究概览

简要总结

The overall goal of this study is to compare the effectiveness of different follow up protocols for scheduled but not attended ("no-show") Well-Child Visits, relative to care-as-usual (no standardized or typical follow up procedure). The main goals are to:

  • Demonstrate feasibility of merging a new referral protocol following Well-Child visit no-show into existing health system Community Health Worker resources.
  • Compare Well-Child Visit attendance following no-show between patients randomized to care-as-usual (comparison), text message only (low-touch intervention), and community health worker outreach (high-touch intervention) groups.
  • Define the costs and cost-effectiveness of different follow-up protocols.

详细描述

Well-Child visits (WCV) are at the core of preventive care in pediatrics. These Visits are an important opportunity for patients to be engaged with the healthcare system, for assessing child health and development, and for screening and counseling for prevention. Missed WCVs have been associated with negative health outcomes as well as avoidable healthcare costs and may occur for a variety of different reasons. There is room for improving follow-up with families to re-engage patients after not attending a scheduled WCV ("no-show"). This study will test and compare a text messaging intervention and community health worker outreach intervention to care-as-usual (no standard follow-up) as strategies for proactively engaging families in care after no-show to promote rescheduling and visit attendance. Evaluating effectiveness and cost-effectiveness of both interventions will inform clinical practice and decision-making in healthcare to help ultimately improve pediatric preventive care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Are 0-17 years
  • No-showed for a well-child visit scheduled at a family medicine or general pediatrics practice in Forsyth County, North Carolina
  • Have a phone number on record for a primary caregiver
  • With primary language for contact that is English or Spanish

排除标准

  • - Already rescheduled their appointment by the time the sample list was generated

研究组 & 干预措施

Care as Usual

No Intervention

In the comparison group, patients' caregivers will not be subject to any standardized follow-up procedure.

Low-touch: Text messaging only

Experimental

The patients' primary caregiver will receive a text message that includes details about the missed appointment, and guidance on rescheduling. Up to three total reminders will be sent, spaced one week apart, if the appointment is not rescheduled in the interim.

干预措施: Low-touch: texting (Behavioral)

High-touch: Community Health Worker outreach

Experimental

Regardless of rescheduling status, the Community Health Worker (CHW) will reach out to the primary phone number on file within approximately 1 week of enrollment in the study. Per usual team protocol, up to three phone call attempts will be made to the primary phone number on file, followed by an attempt to the secondary phone number on file. The CHW will screen the families' needs per their usual protocol and inquire about reasons for no-showing for the scheduled appointment; additional questions will include whether they can provide support for rescheduling the no-showed visit and helping to attend it. The CHW will also have a discretionary fund available through this project to help support the family in addressing instrumental needs if existing resources are not available through the hospital, governmental services, or other organizations.

干预措施: High-touch: Community health worker outreach (Behavioral)

结局指标

主要结局

Proportion of Patients of All Ages with any Completed Well-Child Visits

时间窗: Week 6 post missed well-child visit

Whether any Well-Child visit was completed by each patient (yes/no) following usual care, text intervention or community health worker intervention

Proportion of Patients Under 3 Years Old with any Completed Well-Child Visits

时间窗: Week 6 post missed well-child visit

Whether any Well-Child visit was completed by each patient (yes/no) following usual care, text intervention or community health worker intervention

Proportion of Patients 3 Years and Older with any Completed Well-Child Visits

时间窗: Month 3 post missed well-child visit

Whether any Well-Child visit was completed by each patient (yes/no) following usual care, text intervention or community health worker intervention

次要结局

  • Proportion of Patients of All Ages with Any Rescheduled Well-Child Visit(Week 6 post missed well-child visit)
  • Proportion of Patients 3 Years and Older with Any Rescheduled Well-Child Visit(Month 3 post missed well-child visit)
  • Proportion of Patients of All Ages with Vaccination status up-to-date(6 weeks post missed well-child visit)
  • Proportion of Patients 3 Years and Older with Vaccination status up-to-date(Month 3 post missed well-child visit)
  • Proportion of Patients of All Ages with Any Completed Encounter(6 weeks post missed well-child visit)
  • Proportion of Patients 3 Years and Older with Any Completed Encounter(Month 3 post missed well-child visit)
  • Proportion of Patients of All Ages with Any Non-Well-Child Primary Care Visit(6 weeks post missed well-child visit)
  • Proportion of Patients 3 Years and Older with Any Non-Well-Child Visit Primary Care Visit(Month 3 post missed well-child visit)
  • Proportion of Patients of All Ages with Any Specialist Visit(6 weeks post missed well-child visit)
  • Proportion of Patients 3 Years and Older with Any Specialist Visit(Month 3 post missed well-child visit)
  • Proportion of Patients of All Ages with Any Emergency Department Visit(6 weeks post missed well-child visit)
  • Proportion of Patients 3 Years and Older with Any Emergency Department Visit(Month 3 post missed well-child visit)
  • Proportion of Patients of All Ages with Any Hospitalization(6 weeks post missed well-child visit)
  • Proportion of Patients 3 Years and Older with Any Hospitalization(Month 3 post missed well-child visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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