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临床试验/NCT03797898
NCT03797898已完成不适用

Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care for Young Children

Seattle Children's Hospital4 个研究点 分布在 1 个国家目标入组 937 人开始时间: 2019年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
937
试验地点
4
主要终点
Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits

研究概览

简要总结

Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care using a health educator ("Parent Coach") to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial and social needs screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician's attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines.

The investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset.

详细描述

Well-Child Care (WCC) visits for child preventive care during the first three years of life are critical because they may be the only opportunity before a child reaches preschool to identify and address important social, developmental, behavioral, and health issues that could have significant impact and long-lasting effects on children's lives as adults. Despite its potential, multiple studies have demonstrated that pediatric providers fail to provide all recommended preventive and developmental services at these visits and that most parents leave the visit with unaddressed psychosocial, developmental, and behavioral concerns. Further, these missed opportunities are more pronounced for children in low-income families.

A critical problem is that the structure of WCC in the U.S. cannot support the vast array of WCC needs of families. Key structural problems include (a) reliance on clinicians (pediatricians, family physicians, or nurse practitioners) for basic, routine WCC services, (b) limitation to a 15-minute face-to-face clinician-directed WCC visit for the wide array of education and guidance services in WCC, and (c) lack of a systematic, patient-driven method for visit customization to meet families' needs. These structural problems contribute to the wide variations in processes of care and preventive care outcomes, resulting in poorer quality of WCC and perhaps worse health outcomes, particularly for children in low-income communities.

To address the gaps in current WCC this study introduces a new model of care to meet the needs of children in low-income communities: Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT). PARENT is a team-based approach to care using a health educator ("Parent Coach") to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician's attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines.

To assess the efficacy of PARENT, the investigators will conduct a cluster randomized controlled trial (RCT). The study will be conducted in partnership with 10 clinics.

In preparation for the trial, investigators will use a Community Engagement & Intervention Implementation process that has been successful in previous studies to guide the intervention adaptation process, Parent Coach training, practice workflow, and intervention implementation in the practices. For the study trial, the investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset. The project's community partners include two federally-qualified health centers (FQHC). FQHC #1 has 4 clinics participating in the study and FQHC #2 has 6 clinics participating in the study. The total number of clinics participating in the study is 10 clinics randomized at the clinic level to intervention or control condition. The intervention clinics will implement PARENT for all well-visits through age 2 years at their clinical site, and the control clinics will continue usual care (clinician directed well-visit). 1,000 families will be enrolled at infant age ≤12 months and remain in the study for a period of 12 months. Parents will complete a survey at baseline and at 6 and 12-months post enrollment.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parent/legal guardian-Child dyad attending well child check-up visits for a 2-week to 12- month WCC visit.
  • Parent is English or Spanish proficient
  • For multiple gestations, one infant will be randomly selected as the index child. Infants with special health care needs will not be excluded from the study, since these children generally need the same recommended preventive care services.

排除标准

  • More than one child attending Well-Child Care
  • Legal guardian of child is under 18 years of age
  • Parents who are employed by one of the federally-qualified health centers (FQHCs)
  • Parents/legal guardian not planning to continue receiving well child care services at this clinic for their child in the next 12 months

结局指标

主要结局

Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits

时间窗: 12 months post enrollment

Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics. scale, 0-100, higher is better

Healthcare Utilization: Emergency Department Utilization

时间窗: 12 months post enrollment

any emergency department care visit for the index child in past 12 months (parent report)

次要结局

  • Experiences of Care: Helpfulness of Care Assessment by Parent Report(12 months post enrollment)
  • Healthcare Utilization: Hospitalizations(12 months post enrollment)
  • Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit(Data not collected due to COVID Pandemic restrictions on in clinic observations.)
  • Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits(12 months post enrollment)
  • Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits.(12 months post enrollment)
  • Healthcare Utilization: Well Child Care Visits Up to Date(12 months post enrollment)
  • Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report(12 months post enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tumaini Coker

Associate Professor

Seattle Children's Hospital

研究点 (4)

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