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NCT Number: NCT03721770

Psychological Impact in a Relative, Following the Announcement of the Death of a Loved One After Cardiac Arrest and the Early Request for Organ Donation

The fight against the scarcity of grafts is a major public health issue in France. Despite a very good success rate of transplants from brain-dead donors or living donors, the waiting time for transplantation continues to increase, leading to morbidity and mortality, as well as medical costs. Since 2005, the BioMedicine Agency has implemented a protocol authorizing kidney and liver samples taken from deceased donors after cardiac arrest (DDAC). This type of sampling has become a common practice in several regions of France and Europe. In case of DDAC, the sampling protocol poses a significant temporal constraint, since the patient must be taken within 6 hours after the cardiac arrest. This constraint leads to a specific organization of the announcement of the death and the request for non-opposition to the levy.

The brutal loss of a loved one is a potentially traumatic experience for family members. The manifestations of the pathological components of mourning such as post-traumatic stress disorder, anxio-depressive syndrome, pathological bereavement, are often expressed early in the first year after the death of the loved one. Families of organ donor patients probably represent a population at high risk for the expression of psychiatric conditions such as post-traumatic stress disorder or pathological bereavement. The limited time available to prepare relatives to make a decision could promote the expression of psychiatric morbidity in the short or medium term. The data on this new transplantation procedure and its psychological consequences are insufficient, and we consider that if a state of post-traumatic stress occurred in more than 50% of parents, the procedure of announcement would be reviewed. The purpose of this study is to test this hypothesis.

Most of the work on relatives of potential organ donors has focused on procedures for brain death. Most of this work has focused on characterizing the determinants of acceptance or refusal of organ donation in the family. The literature relating to the follow-up of relatives of a patient after organ donation is very poor: very few studies have focused on the psychological consequences and / or the psychological state of this population in the period post-death. In addition, very few qualitative and quantitative studies make it possible to evaluate the appearance of psychopathological manifestations related to the announcement of death simultaneously with a request for organ removal. This research, therefore, will make it possible to estimate the possible psychological impact on the bereaved family as well as an assessment of the psychological state. A mixed methodology (quantitative and qualitative) will make it possible to highlight explanatory factors of the quantitative results.

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Key information

Conditions

Post Traumatic Stress Disorder Family Mental Disorders Organ and Tissue Procurement Psychological Distress Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ADNET Frederic

Bobigny, 93000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parent or adult companion of a patient who died of cardiac arrest after organ removal (Inclusion order of priority is husband-wife / father-mother / son-daughter)
  • Only one loved one is included per patient.

Exclusion criteria

  • Age < 18 years
  • Refusal to participate in the study
  • Difficulty in communication (foreign, language, etc)

Treatment and study plan

Primary outcomes

  1. Score ≥ 33 on the Impact of Event Scale - Revised.

    Time frame: 3 months

    Percentage of relatives with post-traumatic stress disorder at 3 months with a score ≥ 33 on the Impact of Event Scale - Revised.

    The Impact of Event Scale - Revised measures symptoms of intrusion, avoidance, numbing and hyperarousal with respect to a particular life-threatening event. Subscales of the scale: Intrusion scale (range 0-24 score); avoidance scale (range 0-26 score); hyperarousal scale (range 0-18 score. Range of the scale 0-88 scores.

    Score 24 and more: PTSD is a clinical concern. Score 33 and above : This represents the best cutoff for a probable diagnosis of PTSD Score 37 and more : This is high enough to suppress the immune system's functioning (even 10 years after an impact event).

Secondary outcomes

  1. Post Traumatic Stress Disorder Diagnosis And Major Depressive Episode Diagnosis (Mini International Neuropsychiatric Interview - Version 5.0.0 Module I. Post Traumatic Stress Disorder and Module A. Major Depressive Episode)

    Time frame: 3 months et 1 year

    Psychological Assessment of Post Traumatic Stress Disorder Diagnosis and Major Depressive Episode Diagnosis.

  2. Score of depression and anxiety (Hospital of Anxiety and Depression Scale).

    Time frame: 3 months and 1 year

    Hospital of Anxiety and Depression Scale measures an anxio-depressive symptomatology and evaluates its severity. It does not try to distinguish different types of depression or anxiety states. This scale was constructed excluding any item concerning somatic aspects. Subscale anxiety (range score 0-21) and Subscale depression (range score 0-21). The thresholds for the sub scores are:

    0-7 score = no anxiety disorder or depressive disorder; 8-10 = anxiety disorder or depressive disorder suspected; 11-21 = anxiety disorder or depressive disorder.

    Range total score= 0-42. The thresholds for a total score are:

    0-14 score= no anxiety or depressive disorder 15-42 score= existence of an anxiety or depressive disorder.

  3. Score of pathological mourning (Inventory of Complicated Grief)

    Time frame: 1 year

    Inventory of Complicated Grief measures the symptoms of 'complicated grief'.The complicated grief is identified by the extended length of time of the symptoms, the interference in normal function caused by the symptoms, or by the intensity of the symptoms (for example, intense suicidal thoughts or acts).The complicated grief may appear as a complete absence of grief and mourning, an ongoing inability to experience normal grief reactions, delayed grief, conflicted grief, or chronic grief. Factors that contribute to the chance that one may experience complicated grief include the suddenness of the death, the gender of the person in mourning, and the relationship to the deceased.

    Range total score= 0-88. Respondents with ICG scores greater than 25 are significantly more impaired in social, general, mental and physical health functioning and in bodily pain than those with ICG scores less than or equal to 25.

    No subscales.

Sponsors and collaborators

Lead sponsor

frederic ADNET

Other

Registry information

Official study title

Psychological Impact in a Relative, Following the Announcement of the Death of a Loved One After Cardiac Arrest and the Early Request for Organ Donation: an Observational, Prospective Study

Acronym: REPERPSY

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 26, 2018
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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