A Policy Relevant U.S. Trauma Care System Pragmatic Trial for PTSD and Comorbidity

Study ID
STU 022015-057

Cancer Related

Healthy Volunteers

Study Sites

  • Parkland Health & Hospital System

Natalia Vazquez

Principal Investigator
Joseph Minei


The study will include four types of subjects: Provider staff, provider care managers, control patients, and intervention patients. Provider staff subjects will interact with the development and implementation of PTSD and comorbidity screening and intervention procedures at the site, as well as complete organizational surveys. Care manager subjects, who are a subset of the provider subject group, will consent both control and intervention patients, conduct baseline emergency department/surgical ward interviews with patient subjects, will be trained in and administer the intervention once their respective sites have begun the intervention phase of the stepped wedge trial, and will complete an assessment of organizational and individual experiences with posttraumatic stress symptoms, screening, and intervention procedures. Care manager subjects will also participate in organizational surveys, a semi-structured exit interview, and four standardized patient interviews that will assess their intervention skills. Care managers will be selected based on their working interactions and proximity with injured patients. We anticipate that the majority of provider subjects who consent will complete the study.

Control patient subjects will receive a baseline, 3-, 6-, and 12-month follow-up interview and care as usual. intervention patient subjects will receive a baseline, 3-, 6-, and 12-month follow-up interview, as well as the new intervention treatment provided by the care manager subjects, which will last up to six months.

at uT Southwestern, approximately 1-5 care manager subjects and 1-5 provider subjects will be recruited by the university of Washington (the primary researchers) for a total of 10 provider and care manager subjects. Research staff at uW will consent the provider and care manager subjects utilizing their own iRB approved consent forms. The university of Washington (uW) team will be acting in the capacity of researcher for this portion of the study and the providers at uT Southwestern will be acting in the capacity of subjects, therefore the uW team will be the individuals consenting the Provider and Care Manager Subjects into the protocol from uT Southwestern. Provider and care manager subjects will be faculty and staff at uTSW and Parkland Hospital.

a total of 40 patient subjects will be recruited at Parkland Hospital by designated study care managers. The number of patient subjects assigned to the control or interventional groups depends on which wave of the randomization scheme the site is assigned to.

Local sub-study: We will specifically look at a sample (n [?]50) of primary caregivers of critically ill trauma or surgical patients admitted to the Parkland Hospital SiCu. The primary caregiver will be the family member who is making the healthcare decisions for the patient. Critically ill will be defined as patients requiring prolonged ventilator support ([Greater Than]3 days). at admission, the primary caregiver will be asked to complete the PCL-5 survey which is a validated, self-report screening tool for PTSD used as the standard PTSD screening form at Parkland. The PCL-5 survey consists of 20 questions that assesses the 20 DSM-5 symptoms of PTSD. The point scale is out of 80 and a score of [Greater Than]38 indicates an individual may be experiencing significant symptoms of PTSD that warrant further assessment and intervention. Regardless of the outcome of the patient, the same person will be contacted at 30 and 120 days post-SiCu admission through a phone interview or by mail, to complete the same survey to evaluate the long term effects.

Participant Eligibility

Provider Subjects: All provider subjects must be staff or trainees at the trauma center study sites. As is characteristic of pragmatic trials, provider inclusion criteria for the study are quite broad. Provider subjects need only be involved or linked in someway to the development and implementation of of trauma center screening and intervention services for PTSD and comorbidity. Provider subjects may be from a number of professional backgrounds including MSW, RN, MD, PhD and other backgrounds. Provider subjects must be English speaking.

Patient Subjects: Patient subjects who screen in to this study will be English speaking, 18 years of age or older, and presenting to a trauma center site with injuries requiring admission to the inpatient trauma surgery service and/or emergency department. Patient subjects will undergo a two-step PTSD assessment. In the first step, patients will be eligible for approach if they have at least three risk factors from the 10 domain PTSD risk factor screen (Appendix 1).49 In a second step of the screening procedure, patient subjects will be administered the PTSD Checklist after consenting in to the study. They will be screened into the study only if they score 35 or greater on the PTSD Checklist.

Local sub-study: Participants will be primary caregivers of acute trauma or surgical patients in the Parkland Hospital SICU. Participants must also agree to be contacted at 30 and 120 days post-SICU admission.