Impact of an ICU Diary on the Well-being of Patients and Families. A Prospective Multicenter Mixed Study

NCT02519725 | Completed DMC

• 1 other identifier: ICU DIARY
• Study Type: interventional
• Target: 715
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Disorders Post Traumatic

Keywords

Family; PTSD; Anxiety disorders; Depression disorders; Qualitative research

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Post traumatic stress disorder symptoms in families

  3 months after ICU discharge as measured by the Impact Evaluation Scale-Revised questionaire

• Anxiety and depression related symptoms in patients

  3 months after ICU discharge as measured by the Hospital Anxiety and Depression Scale

• Anxiety and depression related symptoms in families

  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

  3 months after ICU discharge as measured by the memory tool questionnaire

Other Outcomes (1)

• Use of the diary by the patient

  6 months after ICU discharge

Study Arms (2)

With diary

ACTIVE COMPARATOR

a ICU diary is open by staff for the patient and his relatives during the ICU stay

Other: ICU diary

Without diary

NO INTERVENTION

No diary is open during the ICU stay

Interventions

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.

With diary

Eligibility Criteria

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

You may qualify if:

• Patients with his family admitted in an ICU and mechanically ventilated more than 48 hours

You may not qualify if:

• Patients without families admitted in an ICU and mechanically ventilated more than 48 hours
• Patients or families not fluent in French
• Patients moribund
• Patients with a neurologic or psychiatric disease responsible for admission or pre-existing before the ICU admission
• Patients admitted after a cardiac arrest
• Deaf and mute patients

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Fondation de France: collaborator

Study Sites (1)

Medical and surgical Intensive Care unit

Paris, 75014, France

Location

Related Publications (3)

• 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.

  PMID: 35239692 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.

  PMID: 31310299 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.

  PMID: 29141694 DERIVED

Related Links

• Impact of an intensive care unit diary on psychological distress in patients and relatives
• Phenomenologic analysis of healthcare worker perceptions of intensive care unit diaries.
• Writing in and reading ICU diaries: qualitative study of families' experience in the ICU.

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Maité Garrouste-Orgeas, MD

  GHPSJoseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the psychologist is blind for the study for assessing outcome measures
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: August 11, 2015
• Study Start: June 11, 2015
• Primary Completion: February 2, 2017
• Study Completion: August 9, 2017
• Last Updated: March 12, 2018

Record last verified: 2016-06

Locations

FR (1)