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| Name | Class |
|---|---|
| Fondation de France | OTHER |
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The purpose of this study is to assess the influence of an ICU diary implemented during the ICU stay on the psychological well-being of patients and families after ICU discharge.
Implementation of an ICU diary in a randomized design in 36 ICUs in France The ICU diary contains entries from staff and families or relatives
Quantitative description of psychological well-being of the patients and families or relatives are evaluated 3 months after ICU discharge
Qualitative evaluation of how the patient uses the diary is scheduled by a phone interview 6 months after ICU discharge.
An amendment of the ethic committee permitted to increase in 2016/02 both the number of eligible patients to 700 and the number of centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With diary | Active Comparator | a ICU diary is open by staff for the patient and his relatives during the ICU stay |
|
| Without diary | No Intervention | No diary is open during the ICU stay |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICU diary | Other | The intervention is the elaboration of an ICU diary by caregivers and families The first pages of the diary is standardized to include an explanation of the purpose of the diary. The diary is maintained by the family and ICU staff. The only instruction given to the families and staff members about diary entries is to refrain from writing about confidential matters that could not be shared among the patients, the staff and the relatives. Staff members are free to express compassion and their hope, or absence thereof, that the patient would recover. Relatives can speak freely with the patients without receiving guidance from the ICU staff. At the minimum, the ICU staff write a brief entry at each weekly staff meeting. For patients discharged to wards and if he can receive the diary, the diary is given to the patient. If the patient died, the diary is given to the family. |
| Measure | Description | Time Frame |
|---|---|---|
| Post traumatic stress disorder symptoms in patients | IES-R score > 22 | 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire |
| Measure | Description | Time Frame |
|---|---|---|
| Post traumatic stress disorder symptoms in families | IES-R score > 22 | 3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire |
| Anxiety and depression related symptoms in patients |
| Measure | Description | Time Frame |
|---|---|---|
| Use of the diary by the patient | Qualitative research using phenomenology interpretative analysis and thematic analysis | 6 months after ICU discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maité Garrouste-Orgeas, MD | GHPSJoseph | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical and surgical Intensive Care unit | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35239692 | Derived | Flahault C, Vioulac C, Fasse L, Bailly S, Timsit JF, Garrouste-Orgeas M. "A story with gaps": An interpretative phenomenological analysis of ICU survivors' experience. PLoS One. 2022 Mar 3;17(3):e0264310. doi: 10.1371/journal.pone.0264310. eCollection 2022. | |
| 31310299 | Derived | Garrouste-Orgeas M, Flahault C, Vinatier I, Rigaud JP, Thieulot-Rolin N, Mercier E, Rouget A, Grand H, Lesieur O, Tamion F, Hamidfar R, Renault A, Parmentier-Decrucq E, Monseau Y, Argaud L, Bretonniere C, Lautrette A, Badie J, Boulet E, Floccard B, Forceville X, Kipnis E, Soufir L, Valade S, Bige N, Gaffinel A, Hamzaoui O, Simon G, Thirion M, Bouadma L, Large A, Mira JP, Amdjar-Badidi N, Jourdain M, Jost PH, Maxime V, Santoli F, Ruckly S, Vioulac C, Leborgne MA, Bellalou L, Fasse L, Misset B, Bailly S, Timsit JF. Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jul 16;322(3):229-239. doi: 10.1001/jama.2019.9058. |
| Label | URL |
|---|---|
| Impact of an intensive care unit diary on psychological distress in patients and relatives | View source |
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| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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the psychologist is blind for the study for assessing outcome measures
|
HADS score > 8
| 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale |
| Anxiety and depression related symptoms in families | HADS score > 8 | 3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale |
| Recollection of the memories of the ICU stay by the patient | questionnaire ICU tool | 3 months after ICU discharge as measured by the memory tool questionnaire |
| 29141694 | Derived | Garrouste-Orgeas M, Flahault C, Fasse L, Ruckly S, Amdjar-Badidi N, Argaud L, Badie J, Bazire A, Bige N, Boulet E, Bouadma L, Bretonniere C, Floccard B, Gaffinel A, de Forceville X, Grand H, Halidfar R, Hamzaoui O, Jourdain M, Jost PH, Kipnis E, Large A, Lautrette A, Lesieur O, Maxime V, Mercier E, Mira JP, Monseau Y, Parmentier-Decrucq E, Rigaud JP, Rouget A, Santoli F, Simon G, Tamion F, Thieulot-Rolin N, Thirion M, Valade S, Vinatier I, Vioulac C, Bailly S, Timsit JF. The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs. Trials. 2017 Nov 15;18(1):542. doi: 10.1186/s13063-017-2283-y. |
| Phenomenologic analysis of healthcare worker perceptions of intensive care unit diaries. | View source |
| Writing in and reading ICU diaries: qualitative study of families' experience in the ICU. | View source |