Clinical trial NCT04916678: Persistent PostConcussion-Like Symptoms and Post Traumatic Stress Disorder in Patients Presenting at the Emergency Room.
Official title: Persistent PostConcussion-Like Symptoms and Post Traumatic Stress Disorder for Patients Presenting at the Emergency Room: A Multi-center Cluster Randomized Cross-over Implementation Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent PostConcussion-Like Symptoms
Post-Traumatic Stress Disorder
Keywords: Persistent PostConcussion-Like Symptoms
Post-Traumatic Stress Disorder
Emergency Room
EMDR
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: University of Bordeaux
First posted: 2021-06-07
Enrollment: 2897
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a multi-site cluster randomized cross-over trial with two comparative groups. In each site, the control period and intervention period span over a period of 10 days (5 days for control and 5 days for intervention). The sequence of the control and intervention periods will be set at random.
Primary purpose: PREVENTION

Brief summary: Promising results of an early EMDR (Eye Movement Desensitization and Reprocessing) intervention on PCLS (PostConcussion-Like Syndrome) at three months have been shown, suggesting that the availability of psychological care in emergency departments will be useful. The real impact of such a care service remains to be measured. Several factors may modulate the impact of such a measure, leaving the extent of its public health benefit uncertain.

In the SOFTER III trial, the results suggest that high levels of self-rated stress at admission probably play a key role in the development of CPSP and psychological intervention.

The most appropriate study design for such an objective is to follow a cohort of patients in the Emergency Department and to assess the main risk factors for CPSD 4 months later. To this end, all consecutive patients should be asked to participate in a study and complete a risk factor questionnaire, regardless of their level of risk for CPSD.

SOFTER IV offers the opportunity to evaluate the impact of a psychological intervention to reduce the incidence of chronic pain. By acting on the emotions experienced in the Emergency Department, a reduction in acute pain and perhaps in the longer term in chronic pain can be expected. Its psychological aspects, and more specifically the emotional dimension, are known to be related to acute pain. As for the relationship with chronic pain, it exists, but its meaning is not clear because the emotional state is assessed when the pain has already become chronic. It is proposed to integrate the assessment of emotions at inclusion in the project, and to follow up patients 12 months after inclusion to assess the incidence of chronic pain and identify the factors that modulate it. Early intervention in the emergency department, including an early short one-hour EMDR intervention R-TEP (Recent Traumatic Episode Protocol), could thus reduce the incidence of chronic pain.

Detailed description: The study is a multi-site cluster randomized cross-over trial with two comparative groups. In each site, the recruitment period span over a period of 10 days (5 days for control and 5 days for intervention), The control period is a period during which no psychologist is available. ER cares will be provided as usual. The intervention period is a period during which trained psychologists are available in the ER and will provide a short early 1-hour R-TEP EMDR intervention for patients selected with high risk of PCLS. Patient's selection will be conducted using a score developed in previous studies. When no high-risk patient is identified, psychologist could assess other patients and treat them if judged necessary. In this context, they could provide either a R-TEP EMDR or short intervention such as reassurance according to therapist assessment. Otherwise, ER cares will be provided as usual.

In either intervention or control period, all consecutive patients will be proposed to participate in the study that consists in:

(i) completing an inclusion questionnaire to describe reasons for ER attendance, current stress level and preexisting health and symptoms and, in the intervention group, to assess PCLS risk level; (ii) being contacted 4 months later to assess PTSD (using the PCL-5 checklist) and PCLS (using Rivermead criteria).

The national health insurance ID will be collected in the inclusion questionnaire and conserve until it can be used, namely after a specific authorization from Commission Nationale Informatique et Liberté (CNIL). This will allow to compare health care consumption levels in the two groups, as recorded in the national insurance system database (SNIIR-AM).

Eligibility criteria: Inclusion Criteria:

* Age 18 and more
* Conscious, able to provide informed consent, able to understand study procedures and to comply with them for the entire length of the study. Speaking French.

Exclusion Criteria:

* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
* Inability or unwillingness to be contacted for 4-month follow-up interview.
* Pregnancy or breastfeeding.
* Curatorship or guardianship.
* Prisoners.

Primary outcomes:
measure: Proportion of patients with PostConcussion-Like Syndrome (PCLS) at 4 months.
timeFrame: 4 months after inclusion day
Secondary outcomes:
measure: Proportion of patients with PTSD at 4-months
timeFrame: 4 months after inclusion day
measure: Establishment of a PCLS Predictive factors list
timeFrame: 4 months after inclusion day
measure: Assessment of health care consumption
timeFrame: 12 months after inclusion day
measure: Proportion of patients with chronic pain
timeFrame: 12 months after inclusion day
measure: Establishment of chronic pain predictive factors
timeFrame: 12 months after inclusion day
measure: Medication Prescription Opioid Misuse Index scale (POMI-5F) questionnaire
timeFrame: 12 months after inclusion day
measure: Quality of life Medical Outcomes Study Short-Form General Health Survey (SF12) questionnaire
timeFrame: 12 months after inclusion day
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Clichy
country: France
facility: Hôpital Beaujon
city: Colombes
country: France
facility: Hôpital Louis Mourier
city: Libourne
country: France
facility: CH de Libourne
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Paris
country: France
facility: Hôpital Lariboisière
city: Toulouse
country: France
facility: Hôpital Purpan
Study officials:
affiliation: Bordeaux Population Health Research Center (Inserm U1219)
name: Emmanuel LAGARDE, Pr
role: STUDY_CHAIR
References: