Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care
Condition: Preventive Health Services; Health Promotion
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Parent Coach
Intervention type(s): Other
Intervention description(s): The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research