Post Traumatic Stress DisorderLATANCT02329418
Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit
A study testing Explaining withholding and withdrawing life-sustaining therapies along with a written document and Explaining withholding and withdrawing life-sustaining therapies following standard procedure in people with Post Traumatic Stress Disorder, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Relatives of patients in situation of withholding and withdrawing life-sustaining therapies often show post traumatic stress disorder (PTSD) (60%)[1]. This number is even greater when family members are active in this decision (81%) or when communication is not optimal between medical team and family members. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Explaining withholding and withdrawing life-sustaining therapies along with a written document and Explaining withholding and withdrawing life-sustaining therapies following standard procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical team anticipates a decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge
- verbal consent to participate
- Able to communicate in French
Who cannot join
- representant of a patient < 18 years old
- representant of a patient whose stay in ICU lasted less than 48 hours
- representant of a patient without social security
Trial locations and contacts
1 site in 1 country.
France1 site
Anesthesiology and Critical Care Depratment, Grenoble University Hospital
Grenoble, 38043
About this study
Official title: Impact of a Written Document on Post Traumatic Stress Disorder (PTSD) Diagnosed in Family Members After Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit
Relatives of patients in situation of withholding and withdrawing life-sustaining therapies often show post traumatic stress disorder (PTSD) (60%)[1]. This number is even greater when family members are active in this decision (81%) or when communication is not optimal between medical team and family members.
There are several ways to assist families of patients in intensive care units [2], amongst them the use of a written document to explain the environment, therapies and possible outcomes.
Here the investigators want to test the impact of a written document in the context of end-of-life conference in intensive care units. Specifically, this research addresses wether such written support could decrease 3-months post-traumatic stress disorder, anxiety and depression exhibited by the closest family member or the patient representative.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Explaining withholding and withdrawing life-sustaining therapies along with a written document, Explaining withholding and withdrawing life-sustaining therapies following standard procedure
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explaining withholding and withdrawing life-sustaining therapies along with a written documentOther
The document describes the law and the role of family members and medical team in the decision.
Explaining withholding and withdrawing life-sustaining therapies following standard procedureOther
| Study group | Role | What they receive |
|---|---|---|
| Written document | Experimental | Accompanying relatives with a written document when discussing withholding and withdrawing life-sustaining therapies . All other procedures are standard. Receives: Other: Explaining withholding and withdrawing life-sustaining therapies along with a written document |
| Standard | Active comparator | Discussing withholding and withdrawing life-sustaining therapies following standard procedure without written document Receives: Other: Explaining withholding and withdrawing life-sustaining therapies following standard procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PTSD
PTSD is assessed with Impact Event Scale (IES) on the family representative
Measured: 3 months
Secondary outcomes (9)
Rate of depression
Depression is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
Measured: 3 months
Rate of anxiety
Anxiety is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
Measured: 3 months
Mean level of HADS (anxiety and depression subscales)
Measured: 3 months
Mean level of IES
Measured: 3 months
Length of the processus from decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge
Measured: An average of 6 days
Respectfulness of the law regarding withholding and withdrawing life-sustaining therapies
Measured: An average of 6 days
Rate of decision to withhold and withdraw life-sustaining therapies in different intensive care units from the hospital
Measured: ICU discharge (an average of 3 weeks)
Medical Doctor satisfaction with the processus
Measured: ICU discharge (an average of 3 weeks)
Description of the processus
Measured: ICU discharge (an average of 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329418
- Sponsor's protocol ID
- 2014-A00758-39
- Acronym
- LATA
- Status last verified
- Dec 2019
- First submitted
- 29 Dec 2014
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
PubMed 15665319Schmidt M, Azoulay E. Having a loved one in the ICU: the forgotten family. Curr Opin Crit Care. 2012 Oct;18(5):540-7. doi: 10.1097/MCC.0b013e328357f141.
PubMed 22914431Robin S, Labarriere C, Sechaud G, Dessertaine G, Bosson JL, Payen JF. Information Pamphlet Given to Relatives During the End-of-Life Decision in the ICU: An Assessor-Blinded, Randomized Controlled Trial. Chest. 2021 Jun;159(6):2301-2308. doi: 10.1016/j.chest.2021.01.072. Epub 2021 Feb 5.
PubMed 33549600
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Written Document on Post Traumatic Stress Disorder (PTSD) Diagnosed in Family Members After Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02329418
- Acronym / sponsor ID
- LATA / 2014-A00758-39
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Relatives of patients in situation of withholding and withdrawing life-sustaining therapies often show post traumatic stress disorder (PTSD) (60%)[1]. This number is even greater when family members are active in this decision (81%) or when communication is not optimal between medical team and family members.
There are several ways to assist families of patients in intensive care units [2], amongst them the use of a written document to explain the environment, therapies and possible outcomes.
Here the investigators want to test the impact of a written document in the context of end-of-life conference in intensive care units. Specifically, this research addresses wether such written support could decrease 3-months post-traumatic stress disorder, anxiety and depression exhibited by the closest family member or the patient representative.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written document | Experimental | Other: Explaining withholding and withdrawing life-sustaining therapies along with a written documentAccompanying relatives with a written document when discussing withholding and withdrawing life-sustaining therapies . All other procedures are standard. |
| Standard | Active comparator | Other: Explaining withholding and withdrawing life-sustaining therapies following standard procedureDiscussing withholding and withdrawing life-sustaining therapies following standard procedure without written document |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical team anticipates a decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge
- verbal consent to participate
- Able to communicate in French
Key exclusion criteria (3 listed)
- representant of a patient < 18 years old
- representant of a patient whose stay in ICU lasted less than 48 hours
- representant of a patient without social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Explaining withholding and withdrawing life-sustaining therapies along with a written documentThe document describes the law and the role of family members and medical team in the decision. | Other | Written document |
| Explaining withholding and withdrawing life-sustaining therapies following standard procedure | Other | Standard |
Primary outcome
Rate of PTSD
Time frame: 3 months
PTSD is assessed with Impact Event Scale (IES) on the family representative
9 secondary outcomes
Rate of depression
Time frame: 3 months
Rate of anxiety
Time frame: 3 months
Mean level of HADS (anxiety and depression subscales)
Time frame: 3 months
Mean level of IES
Time frame: 3 months
Length of the processus from decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge
Time frame: An average of 6 days
Respectfulness of the law regarding withholding and withdrawing life-sustaining therapies
Time frame: An average of 6 days
Rate of decision to withhold and withdraw life-sustaining therapies in different intensive care units from the hospital
Time frame: ICU discharge (an average of 3 weeks)
Medical Doctor satisfaction with the processus
Time frame: ICU discharge (an average of 3 weeks)
Description of the processus
Time frame: ICU discharge (an average of 3 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Background: PubMed 15665319Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
- Background: PubMed 22914431Schmidt M, Azoulay E. Having a loved one in the ICU: the forgotten family. Curr Opin Crit Care. 2012 Oct;18(5):540-7. doi: 10.1097/MCC.0b013e328357f141.
- Derived from this study: PubMed 33549600Robin S, Labarriere C, Sechaud G, Dessertaine G, Bosson JL, Payen JF. Information Pamphlet Given to Relatives During the End-of-Life Decision in the ICU: An Assessor-Blinded, Randomized Controlled Trial. Chest. 2021 Jun;159(6):2301-2308. doi: 10.1016/j.chest.2021.01.072. Epub 2021 Feb 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Explaining withholding and withdrawing life-sustaining therapies along with a written document and Explaining withholding and withdrawing life-sustaining therapies following standard procedure in people with Post Traumatic Stress Disorder, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of PTSD (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02329418, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019.