Clinical trial NCT06479447: Patient Outcome Reporting for Timely Assessments of Life With Post-Traumatic Stress Disorder
Official title: Patient Outcome Reporting for Timely Assessments of Life With Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PTSD
Keywords: behavioral health
PTSD
PTSD screening
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Chicago Family Health Center
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-06-28
Enrollment: 17000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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. Racial and ethnic minority people residing in sociocultural 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 barriers 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 predominantly racial/ethnic minority 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.

Eligibility criteria: 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

Primary outcomes:
measure: PTSD screening rates
timeFrame: every 6 months post-intervention for 2 years
measure: PTSD diagnoses rates
timeFrame: every 6 months post-intervention for 2 years
measure: PTSD prescribed treatment rates
timeFrame: every 6 months post-intervention for 2 years
measure: PTSD symptoms severity
timeFrame: every 6 months post-intervention for 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: CFHC South Chicago
state: Illinois
city: Chicago
country: United States
facility: CFHC Chicago Lawn
state: Illinois
Study officials:
affiliation: University of Chicago
name: Neda Laiteerapong, MD, MS
role: PRINCIPAL_INVESTIGATOR
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