NCT06989476

Process Mapping to Optimize Child Psychosocial Screenings in Primary Care, and Increase Family Service Linkages

Using Process Mapping to Optimize the Integration of Child Psychosocial Screenings in Primary Care, Promote Whole-person Care, and Increase Family Linkages to Behavioral and Safety Net Services

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Many families screened in primary care for social challenges to identify psychosocial needs of caregivers and children do not receive the follow-up support they need. This study will test a new clinic-based approach, CARELOOP, designed to improve how families are referred to and connected with services. Using community input and a method called Process Service Mapping, the project will tailor clinic workflows and evaluate the approach's impact through a randomized trial. The goal is to improve care coordination and reduce health disparities.

Detailed description

Despite an increased health systems investment in primary care screenings to identify the psychosocial needs of caregivers and children (e.g., exposure to violence, racism, and insecure housing), these efforts don't always result in family-centered service referrals and follow-up to ensure all needs are getting met (i.e., families able to access services such as housing and behavioral health support). When psychosocial needs aren't identified or addressed during childhood, it can cause or worsen children's health conditions, interrupt their development, and, at the societal level, perpetuate disparities in overall health. The investigators' preliminary data identified key strengths and weaknesses within families' journeys through psychosocial screenings, service referral and linkage processes in primary care - which the investigators term "service pathways". The goal of the current study is to optimize the post-screening pathway to increase family referral and linkage follow-up, so that all screened families receive consistent services. The investigators hypothesis is that clinics using the proposed adaptive intervention package will increase family referral and linkage follow-up compared to clinics using current screening practices. A novel and replicable approach to optimize service pathways that include these family-centered elements and implementation strategies is Process Service Mapping (PSM). PSM is an iterative approach to mapping patients' pathways to identify inequities, challenges, and action points. This study seeks to scale up previous work by testing the CARELOOP Intervention (Clinics cAtch needs, REfer, Link to services, and close the lOOp using an equitable family-centered Process). CARELOOP is a system-level intervention that will tailor primary care workflows with PSM-informed decision rules, procedural steps, and implementation strategies with input from clinics and communities. Denver Health is an optimal partner as they are a large safety net system serving minoritized families and 11 pediatric clinics already screen for psychosocial needs using the Health-Related Social Needs and Survey of Well-being of Young Children. The investigators' main hypothesis is that intervention clinics will have higher Service Referrals and Linkages compared to standard care control clinics. After optimizing service pathways (Aim 1), the investigators will conduct a cluster-randomized trial to test the impact of CARELOOP on effectiveness (Aim 2) and implementation outcomes (Aim 3). The study goals are: Aim 1: Engage clinics and communities to refine the CARELOOP intervention by mapping service pathways to include equity and family-centered elements and tailored strategies; Aim 2: Use a parallel-arm cluster randomized trial to test the effectiveness of the CARELOOP intervention; and Aim 3: Conduct an implementation evaluation of the CARELOOP intervention. This R01 study leverages current psychosocial screening practices to rigorously test an intervention designed to increase service referrals and linkages. The investigators bring quality improvement, implementation science, and a novel co-creation engagement approach to accelerate family-centered care

Conditions

• Mental Health Care

Interventions

Type	Name	Description
OTHER	CARELOOP Intervention	CARELOOP Intervention (Clinics cAtch needs, REfer, Link to services, and close the lOOp using an equitable family-centered Process). CARELOOP is a way of enhancing psychosocial screenings through PSM methodology and Implementation Science, and grounded in the Clinical-Community Relationships Evaluation framework

Timeline

• Start date: 2026-02-17
• Primary completion: 2028-12-31
• Completion: 2029-07-31
• First posted: 2025-05-25
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States