Impact of an Intensive Care Diary on Post-traumatic Stress Disorder After a Resuscitated Sudden Death

NCT02874469 | Completed

• 2 other identifiers: 2014_062014-A01213-44
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

Sudden death is a public health problem with more than 300,000 cases per year in USA and 40,000 cases per year in France. Moreover, despite all recent therapeutic improvements (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains drastically poor and less than 50% of the patients admitted alive at hospital will survive to the event at 1 year. Outside all medications and technical care to improve patient prognosis, a psychological evaluation looks also critical to detect the occurrence of a "post traumatic stress syndrome". In fact, along with the event severity, a variable period of amnesia related to coma may favor the occurrence of such a syndrome and psychological issues, which at the end may lead to impairment of patient quality of life. Previous studies have evaluated the impact of an intensive care unit diary on psychological distress in patients and relatives in the context of severe traumatisms. Such an evaluation has however never been done in the specific setting of sudden death and the frequency of this syndrome is unknown in this context. Aim The aim of the present study is to evaluate the impact of an intensive care unit diary on the occurrence of a "post traumatic stress syndrome" after a sudden death. Secondary objectives

• To evaluate the frequency of the occurrence of a "post traumatic stress syndrome" and other psycho traumatic symptoms after sudden death
• To evaluate the impact of an intensive care unit diary on the severity of this syndrome, psycho traumatic symptoms, and psychopathologic comorbidities
• To evaluate the impact of the diary on psycho traumatic symptoms and their severity in patient's relatives
• To evaluate the satisfaction of the patients and their relatives regarding medical cares in both groups (with and without diary)
• Comparison of nurse diagnostic (psychological distress) and diagnostic made by dedicated personal with a specific formation in psychology
• Qualitative evaluation of the diary
• Evaluation of the paramedical feeling before and after the diary input in practice

Conditions

Sudden Death; Sudden Cardiac Arrest

Keywords

sudden death; post-traumatic stress disorder; psychological distress; diary; resuscitation

Outcome Measures

Primary Outcomes (1)

• Rate of occurrence of "post traumatic stress disorder"

  Rate of occurrence of "post traumatic stress syndrome" (CAPS score over 39) at 3 months after resuscitation after sudden death

  3 months

Secondary Outcomes (6)

• Peritraumatic Distress Inventory (PDI) Scale

  1 month

• Psychiatric comorbidities

  3 and 6 months

• Rate of "Post traumatic stress disorder" for patients

  6 months

• Rate of "Post traumatic stress disorder" for relatives

  3 and 6 months

• Nurse diagnosis

  3 months

Study Arms (2)

Control group (first period)

NO INTERVENTION

Patients treated as recommended with usual care in a center.

Group with diary (second period)

EXPERIMENTAL

Intervention group = On top of usual care, an intensive care unit diary will be implemented for patients within the first 8 hours following their admission.

Other: Diary

Interventions

Diary OTHER

The diary was specifically created for the purpose of the present study by personal working at ICU at CHRU of Lille (France). All relatives, doctors and paramedics close to the patient during his hospital stay are allowed to write some comments inside the diary when he is comatose. The diary will be implemented during the second period of the study within the first 8 hours after admission. It will be given to the patients themselves at discharge or to their relatives in case of in-hospital death. An anonymous copy will be kept by investigators.

Group with diary (second period)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who experienced a sudden death and who are admitted alive in our center
• Patients who benefited from therapeutic hypothermia (and/or care to limit fever occurrence)

You may not qualify if:

• Death or transfer in another center within the first 8 hours of admission in our center
• Pregnancy
• Patients who refuse to participate after being awake after initial coma
• Relatives who refuse to participate after being awake after initial coma

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Hôpital Cardiologique - USIC - CHRU

Lille, France

Location

MeSH Terms

Conditions

Death, Sudden; Death, Sudden, Cardiac; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Heart Diseases; Cardiovascular Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Gilles LESMESLE, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 22, 2016
• Study Start: December 31, 2014
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 16, 2025

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)