A patient-centered, coordinated care approach delivered by community and pediatric primary care providers to promote responsive parenting: pragmatic randomized clinical trial rationale and protocol

Abstract

Background: Economically disadvantaged families receive care in both clinical and community settings, but this care is rarely coordinated and can result in conflicting educational messaging. WEE Baby Care is a pragmatic randomized clinical trial evaluating a patient-centered responsive parenting (RP) intervention that uses health information technology (HIT) strategies to coordinate care between pediatric primary care providers (PCPs) and the Special Supplemental Nutrition Program for Women, Infant and Children (WIC) community nutritionists to prevent rapid weight gain from birth to 6 months. It is hypothesized that data integration and coordination will improve consistency in RP messaging and parent self-efficacy, promoting shared decision making and infant self-regulation, to reduce infant rapid weight gain from birth to 6 months.

Methods/design: Two hundred and ninety mothers and their full-term newborns will be recruited and randomized to the "RP intervention" or "standard care control" groups. The RP intervention includes: 1) parenting and nutrition education developed using the American Academy of Pediatrics Healthy Active Living for Families curriculum in conjunction with portions of a previously tested RP curriculum delivered by trained pediatric PCPs and WIC nutritionists during regularly scheduled appointments; 2) parent-reported data using the Early Healthy Lifestyles (EHL) risk assessment tool; and 3) data integration into child's electronic health records with display and documentation features to inform counseling and coordinate care between pediatric PCPs and WIC nutritionists. The primary study outcome is rapid infant weight gain from birth to 6 months derived from sex-specific World Health Organization adjusted weight-for-age z-scores. Additional outcomes include care coordination, messaging consistency, parenting behaviors (e.g., food to soothe), self-efficacy, and infant sleep health. Infant temperament and parent depression will be explored as moderators of RP effects on infant outcomes.

Discussion: This pragmatic patient-centered RP intervention integrates and coordinates care across clinical and community sectors, potentially offering a fundamental change in the delivery of pediatric care for prevention and health promotion. Findings from this trial can inform large scale dissemination of obesity prevention programs.

Trial registration: Restrospective Clinical Trial Registration: NCT03482908 . Registered March 29, 2018.

Keywords: And children program; Clinical care; Coordination of care; Early obesity prevention; Health information technology; Infants; Responsive parenting; The special supplemental women.

Conflict of interest statement

Ethics approval and consent to participate

Participants completed an electronic consent form prior to being enrolled into the study. The process of data sharing was possible between Geisinger and the Pennsylvania Department of Health and Human Services (i.e., WIC) given an executed data sharing agreement between institutions. This study was approved by the Institutional Review Boards of Geisinger, a large integrated health system, and The Pennsylvania State University.

Consent for publication

Uploaded in submission process using BMC pediatrics consent form.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

WEE Baby Care CONSORT as of 4/17/18

Fig. 2

An illustration of a framework that integrates clinical and community systems to prevent and manage obesity

Fig. 3

WEE Baby Care flow chart for care coordination and data sharing