Addressing adverse social determinants of health in pediatric primary care: Study protocol for a hybrid type 2 effectiveness-implementation randomized controlled trial in two national pediatric practice-based research networks

Abstract

Background: Growing evidence linking social determinants of health (SDOH) to child health outcomes has prompted widespread recommendations for pediatricians to screen and refer for adverse SDOH at primary care visits. Yet there is little evidence to date demonstrating the effectiveness of practice-based SDOH screening and referral interventions on increasing family engagement with resources. This hybrid type 2 effectiveness-implementation trial aims to demonstrate the non-inferiority of a low-touch implementation strategy in order to facilitate dissemination of an existing SDOH screening and referral system (WE CARE) and demonstrate its effectiveness and sustainability in various pediatric practices.

Methods: We recruited eighteen pediatric practices in fourteen US states through two pediatric practice-based research networks. For this stepped wedge cluster RCT, practices serve as their own controls during the Usual Care phase and implement WE CARE during the intervention phase via one of two randomized implementation strategies: self-directed, pre-recorded webinar vs. study team-facilitated, live webinar. We collect data at practice, clinician/staff, and parent levels to assess outcomes grounded in the Proctor Conceptual Model of Implementation Research. We use generalized mixed effects models and differences in proportions to compare rates of resource referrals by implementation strategy, and intention-to-treat analysis to compare odds of engagement with new resources among families enrolled in the Usual Care vs. WE CARE phases.

Discussion: Findings from this trial may inform decisions about broader dissemination of SDOH screening systems into a diverse spectrum of pediatric practices across the US and potentially minimize the impact of adverse SDOH on children and families.

Keywords: Pediatrics; Social determinants of health; Social needs; Social risks; Social screening tools.

Figure 1.

Proctor Conceptual Model of Implementation Research, applied to WE CARE Study.

Figure 2.

Map of WE CARE study sites, coded by urbanicity, practice-based research network, and randomized implementation strategy assignment.

Figure 3.

Stepped-wedge cluster randomized trial design with multiple data collection points for the WE CARE study. Please note that this figure is not to scale. The dotted line signifies when the COVID-19 pandemic began (March 2020) during the study period. Study Phases and Activities:

1. 1^st phase is Usual Care

2. 2^nd phase is Core Training (X= Live Webinar, O=Pre-recorded Webinar)

3. 3^rd phase is Pilot

4. 4^th is WE CARE

5. Δ signifies Chart Review Period

Relationship to Study Aims:

1. Non-inferiority Evaluation: Comparison of X vs. O

2. Implementation Evaluation: Proportion of visits with completed screener from Chart Review

3. Effectiveness Evaluation: Comparison of parent surveys in Usual Care phase vs. WE CARE phase