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

NCT06479447 | Recruiting DMC

• 2 other identifiers: IRB23-17595P50MD017349-04
• Study Type: interventional
• Target: 17,000
• Locations: 1 country
• Sites: 2

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).

Conditions

PTSD

Keywords

behavioral health; PTSD; PTSD screening

Outcome Measures

Primary Outcomes (4)

• PTSD screening rates

  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

  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

• PTSD prescribed treatment rates

  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

  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

Study Arms (2)

PORTAL-PTSD Intervention

EXPERIMENTAL

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

No PORTAL-PTSD Intervention

NO INTERVENTION

Standard of care offered to all patients

Interventions

PORTAL-PTSD 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.

PORTAL-PTSD Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Chicago: lead
• Chicago Family Health Center: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

CFHC South Chicago

Chicago, Illinois, 60617, United States

RECRUITING

CFHC Chicago Lawn

Chicago, Illinois, 60629, United States

RECRUITING

Related Publications (10)

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• Druss BG, Zhao L, Von Esenwein S, Morrato EH, Marcus SC. Understanding excess mortality in persons with mental illness: 17-year follow up of a nationally representative US survey. Med Care. 2011 Jun;49(6):599-604. doi: 10.1097/MLR.0b013e31820bf86e.

  PMID: 21577183 BACKGROUND

• Beristianos MH, Yaffe K, Cohen B, Byers AL. PTSD and Risk of Incident Cardiovascular Disease in Aging Veterans. Am J Geriatr Psychiatry. 2016 Mar;24(3):192-200. doi: 10.1016/j.jagp.2014.12.003. Epub 2014 Dec 9.

  PMID: 25555625 BACKGROUND

• O'Donnell CJ, Schwartz Longacre L, Cohen BE, Fayad ZA, Gillespie CF, Liberzon I, Pathak GA, Polimanti R, Risbrough V, Ursano RJ, Vander Heide RS, Yancy CW, Vaccarino V, Sopko G, Stein MB. Posttraumatic Stress Disorder and Cardiovascular Disease: State of the Science, Knowledge Gaps, and Research Opportunities. JAMA Cardiol. 2021 Oct 1;6(10):1207-1216. doi: 10.1001/jamacardio.2021.2530.

  PMID: 34259831 BACKGROUND

• Liu MY, Li N, Li WA, Khan H. Association between psychosocial stress and hypertension: a systematic review and meta-analysis. Neurol Res. 2017 Jun;39(6):573-580. doi: 10.1080/01616412.2017.1317904. Epub 2017 Apr 17.

  PMID: 28415916 BACKGROUND

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  PMID: 28932967 BACKGROUND

• Hackett RA, Steptoe A. Type 2 diabetes mellitus and psychological stress - a modifiable risk factor. Nat Rev Endocrinol. 2017 Sep;13(9):547-560. doi: 10.1038/nrendo.2017.64. Epub 2017 Jun 30.

  PMID: 28664919 BACKGROUND

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  PMID: 17199060 BACKGROUND

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  PMID: 21792377 BACKGROUND

• Schein J, Houle C, Urganus A, Cloutier M, Patterson-Lomba O, Wang Y, King S, Levinson W, Guerin A, Lefebvre P, Davis LL. Prevalence of post-traumatic stress disorder in the United States: a systematic literature review. Curr Med Res Opin. 2021 Dec;37(12):2151-2161. doi: 10.1080/03007995.2021.1978417. Epub 2021 Sep 23.

  PMID: 34498953 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Neda Laiteerapong, MD, MS

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ainur Kagarmanova, MS, MA

CONTACT

5742865712; akagarmanova@bsd.uchicago.edu

Erin Staab, MPH

CONTACT

5072619859; estaab@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 14, 2026
• Study Completion (Estimated): July 14, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-05

Locations

US (2)