Cardiopulmonary Resuscitation Witnessing by a Relative (PRESENCE)
Primary Purpose
Cardiac Arrest
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Usual strategy
Modified strategy
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Arrest focused on measuring Out-of-hospital, Emergency, Cardiac arrest, Post-traumatic stress disorder
Eligibility Criteria
Inclusion Criteria:
- Patient victim of a cardiac arrest and resuscitation initiated
- Occurrence of cardiac arrest at home
Presence of a relative :
- husband or spouse
- father or mother
- son or daughter
- brother or sister
- Patient's age ≥ 18 years
- Relative's age ≥ 18 years
- Consent of the relative to the participation in the study
Exclusion Criteria:
- No understanding of the explanations (language problem, important agitation)
- Non-affiliated to social security
Sites / Locations
- SAMU 93 - Hôpital Avicenne
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm 1 : Control : usual strategy
Arm 2: Comparator : modified strategy
Arm Description
Outcomes
Primary Outcome Measures
Percentage of relatives having a score of the Impact of Events Scale (IES) > 30
Secondary Outcome Measures
Psychological questionnaires as the hospital anxiety and depression scale (HAD), the Mini International Neuropsychiatric Interview (MINI), the Inventory of Complicated Grief (ICG)
Psychological follow-up
Suicide
Medico-legal recourse
Quality of the cardiopulmonary resuscitation
Questionnaire evaluating the stress of the medical and paramedical team
Full Information
NCT ID
NCT01009606
First Posted
November 6, 2009
Last Updated
January 17, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT01009606
Brief Title
Cardiopulmonary Resuscitation Witnessing by a Relative
Acronym
PRESENCE
Official Title
Interest for a Relative of Seeing Himself Proposing to Witness Resuscitation of a Family Member Victim of a Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The bereavement generated by the loss of a family member can induce pathological situations: depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid factors can be influenced by the death circumstances and in particular by the possibility given to the family to attend the medical management of the patient. This clinical trial aims to evaluate the psychological consequences of bereavement on the relatives according to the possibility of witnessing the cardiopulmonary resuscitation of a family member. This possibility lies within the scope of a strategy of global management of the relatives.
Detailed Description
This clinical trial aims to compare the presence of post-traumatic stress disorder on a relative related to the death of a family member:
Test group: the medical team will propose to the relative to witness the cardiopulmonary resuscitation.
Control group: the medical team will not modify its usual management of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Out-of-hospital, Emergency, Cardiac arrest, Post-traumatic stress disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
570 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 : Control : usual strategy
Arm Type
Active Comparator
Arm Title
Arm 2: Comparator : modified strategy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Usual strategy
Intervention Description
Usual strategy
Intervention Type
Other
Intervention Name(s)
Modified strategy
Intervention Description
Proposition to a relative to witness the cardiopulmonary resuscitation of a family member and debriefing ot the situation
Primary Outcome Measure Information:
Title
Percentage of relatives having a score of the Impact of Events Scale (IES) > 30
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Psychological questionnaires as the hospital anxiety and depression scale (HAD), the Mini International Neuropsychiatric Interview (MINI), the Inventory of Complicated Grief (ICG)
Time Frame
3 and 12 months
Title
Psychological follow-up
Time Frame
3 months
Title
Suicide
Time Frame
3 and 12 months
Title
Medico-legal recourse
Time Frame
12 months
Title
Quality of the cardiopulmonary resuscitation
Time Frame
day 0
Title
Questionnaire evaluating the stress of the medical and paramedical team
Time Frame
day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient victim of a cardiac arrest and resuscitation initiated
Occurrence of cardiac arrest at home
Presence of a relative :
husband or spouse
father or mother
son or daughter
brother or sister
Patient's age ≥ 18 years
Relative's age ≥ 18 years
Consent of the relative to the participation in the study
Exclusion Criteria:
No understanding of the explanations (language problem, important agitation)
Non-affiliated to social security
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric ADNET, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
SAMU 93 - Hôpital Avicenne
City
Bobigny
State/Province
Ile de France
ZIP/Postal Code
93000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27618681
Citation
Jabre P, Bougouin W, Dumas F, Carli P, Antoine C, Jacob L, Dahan B, Beganton F, Empana JP, Marijon E, Karam N, Loupy A, Lefaucheur C, Jost D, Cariou A, Adnet F, Rea TD, Jouven X. Early Identification of Patients With Out-of-Hospital Cardiac Arrest With No Chance of Survival and Consideration for Organ Donation. Ann Intern Med. 2016 Dec 6;165(11):770-778. doi: 10.7326/M16-0402. Epub 2016 Sep 13.
Results Reference
derived
PubMed Identifier
24852952
Citation
Jabre P, Tazarourte K, Azoulay E, Borron SW, Belpomme V, Jacob L, Bertrand L, Lapostolle F, Combes X, Galinski M, Pinaud V, Destefano C, Normand D, Beltramini A, Assez N, Vivien B, Vicaut E, Adnet F. Offering the opportunity for family to be present during cardiopulmonary resuscitation: 1-year assessment. Intensive Care Med. 2014 Jul;40(7):981-7. doi: 10.1007/s00134-014-3337-1. Epub 2014 May 23.
Results Reference
derived
PubMed Identifier
23484827
Citation
Jabre P, Belpomme V, Azoulay E, Jacob L, Bertrand L, Lapostolle F, Tazarourte K, Bouilleau G, Pinaud V, Broche C, Normand D, Baubet T, Ricard-Hibon A, Istria J, Beltramini A, Alheritiere A, Assez N, Nace L, Vivien B, Turi L, Launay S, Desmaizieres M, Borron SW, Vicaut E, Adnet F. Family presence during cardiopulmonary resuscitation. N Engl J Med. 2013 Mar 14;368(11):1008-18. doi: 10.1056/NEJMoa1203366.
Results Reference
derived
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Cardiopulmonary Resuscitation Witnessing by a Relative
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