Patient Outcome Reporting for Timely Assessments of Life With Post-Traumatic Stress Disorder (PORTAL-PTSD)

November 6, 2025 updated by: University of Chicago
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

17000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Patient 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No PORTAL-PTSD Intervention
Standard of care offered to all patients
Experimental: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD prescribed treatment rates
Time Frame: every 6 months post-intervention for 2 years
Treatment rate is measured as proportion of patients with PTSD and prescribed treatment out of total patients diagnosed with PTSD. Receipt of treatment is defined by completion of PCBH services or at least 3-months of therapy for PTSD for patients who choose to not receive PCBH services.
every 6 months post-intervention for 2 years
PTSD symptoms severity
Time Frame: every 6 months post-intervention for 2 years
Patient-reported improvement in PTSD symptoms severity as measured by the 20-item Post-Traumatic Stress Disorder Checklist (PCL).
every 6 months post-intervention for 2 years
PTSD screening rates
Time Frame: every 6 months post-intervention for 2 years
Number and proportion of patients who were screened for PTSD, as determined by the validated Primary Care Post-Traumatic Stress Disorder screener (PC-PTSD-5).
every 6 months post-intervention for 2 years
PTSD diagnoses rates
Time Frame: every 6 months post-intervention for 2 years
Number and proportion of patients who screen positive for PTSD, as determined by the validated Primary Care Post-Traumatic Stress Disorder screener (PC-PTSD-5).
every 6 months post-intervention for 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
Chicago Family Health Center

Investigators

  • Principal Investigator: Neda Laiteerapong, MD, MS, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2024

Primary Completion (Estimated)

July 14, 2026

Study Completion (Estimated)

July 14, 2026

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

November 10, 2025

Last Update Submitted That Met QC Criteria

November 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB23-1759
  • 5P50MD017349-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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