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

NCT ID: NCT06989476

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-17
• Study Completion Date: 2029-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

CARELOOP Intervention Group

Clinics using the CARELOOP intervention to screen children ages 0 to 5 and link children and their caregivers to support services

Group Type: EXPERIMENTAL

CARELOOP Intervention

Intervention Type: OTHER

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

Standard Care

Clinics screening children ages 0-5 years to identify psychosocial and activate referrals per standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Caregiver of child is 18 years or older with legal custody or authority to arrange care for child ages 0-5 years old.
• Caregiver provides informed consent
• Caregiver provides permission for socio-demographic information about their child to be pulled from EMR records, de-identified, and shared with PI

Exclusion Criteria

• Caregiver declines to provide signed informed consent, HIPAA release, or permission for socio-demographic data to be pulled from the Electronic Medical Records (EMR), de-identified and shared with PI;
• Children ages 6-18 scheduled for wellness visits
• Children ages 0-5 scheduled for wellness visits outside the study data collection windows or at clinics not providing pediatric care
• Caregiver does not have legal guardianship or written authority to arrange care for the child

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Denver Health and Hospital Authority

OTHER

Sponsor Role: collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Denver Health

Denver, Colorado, United States

Countries

United States

Other Identifiers

1R01HS029858-01A1

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

24-1929

Identifier Type: -

Identifier Source: org_study_id