Patient Outcome Reporting for Timely Assessments of Life With Post-Traumatic Stress Disorder (PORTAL-PTSD)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Ainur Kagarmanova, MS, MA
- Phone Number: 5742865712
- Email: akagarmanova@bsd.uchicago.edu
Study Contact Backup
- Name: Erin Staab, MPH
- Phone Number: 5072619859
- Email: estaab@bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60629
- Recruiting
- CFHC Chicago Lawn
-
Contact:
- Melissa Duplantis, PsyD
- Phone Number: 773-768-5000
- Email: mduplantis@chicagofamilyhealth.org
-
Chicago, Illinois, United States, 60617
- Recruiting
- CFHC South Chicago
-
Contact:
- Melissa Duplantis
- Phone Number: 773-768-5000
- Email: mduplantis@chicagofamilyhealth.org
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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.
|
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
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
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Neda Laiteerapong, MD, MS, University of Chicago
Publications and helpful links
General Publications
- Kubzansky LD, Koenen KC, Spiro A 3rd, Vokonas PS, Sparrow D. Prospective study of posttraumatic stress disorder symptoms and coronary heart disease in the Normative Aging Study. Arch Gen Psychiatry. 2007 Jan;64(1):109-16. doi: 10.1001/archpsyc.64.1.109.
- Mensah GA, Collins PY. Understanding mental health for the prevention and control of cardiovascular diseases. Glob Heart. 2015 Sep;10(3):221-4. doi: 10.1016/j.gheart.2015.08.003.
- 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.
- 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.
- 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.
- 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.
- Wirtz PH, von Kanel R. Psychological Stress, Inflammation, and Coronary Heart Disease. Curr Cardiol Rep. 2017 Sep 20;19(11):111. doi: 10.1007/s11886-017-0919-x.
- 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.
- Coughlin SS. Post-traumatic Stress Disorder and Cardiovascular Disease. Open Cardiovasc Med J. 2011;5:164-70. doi: 10.2174/1874192401105010164. Epub 2011 Jul 11.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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