CARELOOP for Mental Health

(CARELOOP Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Consent, Hipaa release, Guardianship, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

330 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for families with children who have been screened in primary care for social challenges. It aims to help caregivers and their kids get better follow-up support. The study seeks participants willing to try a new approach called CARELOOP, which may improve service referrals and connections.

Inclusion Criteria

I am over 18 and legally responsible for a child aged 0-5.

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

My child, aged 6-18, is scheduled for a wellness visit.

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

Caregiver does not have legal guardianship or written authority to arrange care for the child

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of the CARELOOP intervention to optimize service pathways and increase family referral and linkage follow-up

2 years

Follow-up

Participants are monitored for effectiveness of service referrals and linkages

2 years

Treatment Details

Interventions

• CARELOOP Intervention

Trial Overview The CARELOOP intervention is being tested to see if it can enhance the way clinics refer families to services after identifying psychosocial needs. This randomized trial will assess whether tailored clinic workflows can boost care coordination and tackle health disparities.

Participant Groups

Group I: CARELOOP Intervention Group Experimental Treatment 1 Intervention

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

Group II: Standard Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Denver Health and Hospital Authority

Collaborator

Trials

106

Recruited

403,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+