Physical Trauma Patients with Symptoms of an Acute and Posttraumatic Stress Disorder: Protocol for an Observational Prospective Cohort Study.

BACKGROUND: Injury, medical treatment, and rehabilitation can have major impacts on patients' wellbeing. About 25-33% of the patients experience an acute stress disorder (ASD) or a posttraumatic stress disorder (PTSD) after injury. ASD is a relatively new diagnosis. Therefore, knowledge about patients' experiences, the course of ASD and PTSD, and who is at risk for developing ASD or PTSD is lacking.

OBJECTIVE: The aims of this multi-method study are to explore patients' experiences with injury (and their care) using a focus group study. Then, in the observational study, different courses of ASD, PTSD, and quality of life will be examined. In addition, this study will examine if these courses could be characterized by socio-demographic, clinical, and psychological variables. Consequently, a risk profile will be developed to determine which patients are at risk for developing ASD or PTSD during the 12 months after injury.

METHODS: Trauma patients treated in the shock room (in 2015) of the Elisabeth-TweeSteden Hospital will share their experiences with injury in the focus group study. Open, axial, and selective coding will be used to analyze the data. Concerning the observational study, patients treated in the shock room (during 2016 and 2017, Elisabeth-TweeSteden Hospital and Erasmus Medical Centre) will be asked to participate. The inclusion period is 12 months. Participants will complete the Impact of Event Scale-Revised, MINI-plus, the Hospital Anxiety and Depression Scale, and the World Health Organization Quality of Life-BREF after inclusion and at 3, 6, 9, and 12 months after injury. The NEO-Five Factor Inventory and the State-Trait Anxiety Inventory-Trait are completed after inclusion only. Repeated measures of latent class analysis and linear mixed models will be used to examine the research aims.

RESULTS: This project was funded in August 2015 by ZonMw. The results of the focus group study are expected in the first trimester of 2018. With regard to the observational study, recruitment is currently underway. Data collection will be completed in November 2018. The first results will be expected in the first trimester of 2019.

CONCLUSIONS: This is the first multi-method study in trauma patients that examines patients' experiences (qualitative design) as well as psychological disorders (observational prospective). This study will contribute to necessary information on psychological consequences after injury. Moreover, it provides knowledge about which patients to include in future psychological intervention research. Finally, awareness in clinicians about the psychological consequences can be created, so they are able to act more effectively to provide patient-oriented care.

TRIAL REGISTRATION: Netherlands Trial Registry NTR6258; https://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6258 (Archived by WebCite at https://www.webcitation.org/6xSCiO1bS).