Patient Outcome Reporting for Timely Assessments of Life With Post-Traumatic Stress Disorder

NCT ID: NCT06479447

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 17000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2026-07-14

Brief Summary

This study aims to implement and evaluate a more timely approach to post-traumatic stress disorder (PTSD) diagnosis and management, entitled Patient Outcome Reporting for Timely Assessments of Life with Post-Traumatic Stress Disorder (PORTAL-PTSD) in a primary care setting with a high prevalence of trauma, specifically the South Side of Chicago, in partnership with Chicago Family Health Center (CFHC).

Detailed Description

Traumatic stress and post-traumatic stress disorder (PTSD) are highly prevalent and lead to increases in psychiatric and cardiovascular disease. People residing in environments entrenched in community violence or experiencing assault are at especially high risk of PTSD. However, many people with PTSD are not diagnosed or treated. Current practices for identifying PTSD are subject to bias because diagnosis depends on clinician- or patient-initiated discussion of trauma-related symptoms, and stigma, knowledge, time, and access to resources are often obstacles to these discussions. System-level solutions are needed to increase diagnosis and treatment of PTSD. Systematic screening protocols can help address bias in who is screened. A keystone to screening for PTSD could be to screen patients when they are at clinic visits. While no formal recommendation exists for PTSD screening, clinics who serve patients at a high risk for PTSD, for example, the Veterans Affairs, have implemented screening at clinic visits. Use of patient portals may provide another promising strategy to address barriers to PTSD screening. In the investigators' previous work, a population health approach was used to screen for and assess depression symptoms, employing the patient portal as a tool to reach out to patients. The investigators found that it resulted in a higher screening rate and identified more patients with moderate-severe depression. After identifying patients with PTSD, the next necessary step is to provide evidence-based treatments, like integrated primary-care behavioral health (PCBH). Integrated primary care-behavioral health (PCBH) is a model of care in which the behavioral health and primary care teams are collocated with the primary care clinic and work together to address the biopsychosocial factors that are affecting a patient's health. PCBH has been found to be less stigmatizing for patients with PTSD and models of care that are proactive and provide telephonic care management have been found to increase treatment engagement for PTSD. Thus, coupling screening for PTSD with a PCBH model may be a highly effective strategy to improving PTSD outcomes. Therefore, the investigators' goal is to implement and evaluate a novel strategy for screening and management of PTSD in a primary care setting with a high prevalence of trauma, specifically the South Side of Chicago. In partnership with Chicago Family Health Center, a federally qualified health center (FQHC) with 5 clinical sites and PCBH, the investigators aim to 1) Implement a system-level screening and management strategy for PTSD. The investigators will implement a process of clinic visit and population health screening for PTSD leveraging the patient portal with linkage to care within a PCBH model and 2) Evaluate a system-level screening and management strategy for PTSD. With these aims, this grant will lead to increased understanding of the utility and feasibility of screening and managing PTSD in an FQHC that serves a population with high rates of trauma exposure. If proven effective, the investigators will evaluate this model of care in a multi-center trial of FQHCs.

Conditions

PTSD

Keywords

behavioral health; PTSD; PTSD screening

Study Design

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

Study Groups

PORTAL-PTSD Intervention

Chicago Family Health Center clinics are randomly assigned to any of the 5 steps. The PORTAL-PTSD intervention is implemented after clinic staff and clinicians have been trained.

Group Type: EXPERIMENTAL

PORTAL-PTSD

Intervention Type: OTHER

Patients will be eligible if they are 18+ years, have had a primary care visit in the last 2 years, and have not been screened for PTSD in the last year. The validated PC-PTSD-5 (Primary Care Post Traumatic Stress Disorder-5) screener will be used. Clinics will implement visit-based and population health screening for patients enrolled in the patient portal who have not been screened for PTSD in the last year and have had a clinic appointment in the last 2 years. The PCBH care manager or patient navigator will follow-up with patients every 2 weeks to ensure they have been connected to care and re-measure their PTSD symptoms. The follow-up calls will continue until symptom remission, after which follow-ups will occur quarterly for 6 months. Primary care clinicians will receive training on trauma-informed care and PTSD management, and will be surveyed at baseline, immediately after training, and 6 months-post intervention to evaluate changes in their knowledge of trauma-informed care.

No PORTAL-PTSD Intervention

Standard of care offered to all patients

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PORTAL-PTSD

Patients will be eligible if they are 18+ years, have had a primary care visit in the last 2 years, and have not been screened for PTSD in the last year. The validated PC-PTSD-5 (Primary Care Post Traumatic Stress Disorder-5) screener will be used. Clinics will implement visit-based and population health screening for patients enrolled in the patient portal who have not been screened for PTSD in the last year and have had a clinic appointment in the last 2 years. The PCBH care manager or patient navigator will follow-up with patients every 2 weeks to ensure they have been connected to care and re-measure their PTSD symptoms. The follow-up calls will continue until symptom remission, after which follow-ups will occur quarterly for 6 months. Primary care clinicians will receive training on trauma-informed care and PTSD management, and will be surveyed at baseline, immediately after training, and 6 months-post intervention to evaluate changes in their knowledge of trauma-informed care.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Had an appointment at the study site in the last 24 months
• Were not screened for PTSD in the last 12 months

Exclusion Criteria

• N/A

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chicago Family Health Center

UNKNOWN

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neda Laiteerapong, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

CFHC South Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

CFHC Chicago Lawn

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ainur Kagarmanova, MS, MA

Role: CONTACT

Phone: 5742865712

Email: akagarmanova@bsd.uchicago.edu

Erin Staab, MPH

Role: CONTACT

Phone: 5072619859

Email: estaab@bsd.uchicago.edu

Facility Contacts

Melissa Duplantis

Role: primary

Melissa Duplantis, PsyD

Role: primary

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Other Identifiers

5P50MD017349-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB23-1759

Identifier Type: -

Identifier Source: org_study_id