Intensive Care Unit (ICU) Diary Project

NCT04305353 | Completed

• 2 other identifiers: ICU Diary RCT NOLAGH-17-022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, include ICU-related PTSD (post-traumatic stress disorder), depression and anxiety.

Conditions

PTSD; Post ICU Syndrome

Keywords

psychocognitive morbidity; narrative medicine; ICU-related PTSD; Post-ICU Syndrome (PICS); ICU Diary

Outcome Measures

Primary Outcomes (1)

• Change in PTSD symptoms

  Revised Impact of Event Scales (IES-R) score, measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. Scores from 1-22 are consistent with mild PTSD, and scores greater than 22 signal clinically significant PTSD symptoms.

  at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge

Secondary Outcomes (3)

• Change in Hospital-associated Depression and Anxiety symptoms

  at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge

• Change in Depression symptoms

  at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge

• Change in Anxiety symptoms

  at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge

Study Arms (2)

ICU Diary Group

EXPERIMENTAL

Patients randomized to this group receive the ICU diary, along with PTSD education

Other: Diary (blank journal) plus PTSD psycho-education; Other: PTSD psycho-education alone

PTSD Education-only Group

OTHER

Control Group: patients randomized to this group only receive PTSD education

Other: PTSD psycho-education alone

Interventions

Diary (blank journal) plus PTSD psycho-education OTHER

A blank journal where a prospective account of a patient's ICU course (everyday events) can be documented by family members and healthcare providers

ICU Diary Group

PTSD psycho-education alone OTHER

We administered a pamphlet to patients with information regarding PTSD symptoms, potential psychiatric complications after discharge, and available mental health resources. References for our education include the following which are included in our references section: Jensen 2015, Jones 2010, Knowles 2009, Parker 2015, Wintermann 2015.

ICU Diary Group; PTSD Education-only Group

Eligibility Criteria

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

You may qualify if:

• admitted to the intensive care unit for at least 72 hours
• sedated and mechanically ventilated for at least 24 hours.
• available over-the-phone, up to 6 months post-ICU discharge

You may not qualify if:

• any patients who do not voluntarily agree to participate
• not fluent in the English language
• patients who have stayed in the ICU for less than 72 hours
• patients who have been sedated and mechanically ventilated for less than 24 hours
• patients with pre-existing severe psychotic illness, bipolar disorder, substance use disorder, PTSD, stroke, traumatic brain injury, neurocognitive impairment, or intellectual disability
• patients with no phone number or reliable contact information for the sake of follow-up
• prisoners
• pregnant patients

Sponsors & Collaborators

• Tulane University School of Medicine: lead
• The Arnold P. Gold Foundation: collaborator

Study Sites (1)

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Related Publications (14)

• Parker AM, Sricharoenchai T, Raparla S, Schneck KW, Bienvenu OJ, Needham DM. Posttraumatic stress disorder in critical illness survivors: a metaanalysis. Crit Care Med. 2015 May;43(5):1121-9. doi: 10.1097/CCM.0000000000000882.

  PMID: 25654178 BACKGROUND

• Wintermann GB, Brunkhorst FM, Petrowski K, Strauss B, Oehmichen F, Pohl M, Rosendahl J. Stress disorders following prolonged critical illness in survivors of severe sepsis. Crit Care Med. 2015 Jun;43(6):1213-22. doi: 10.1097/CCM.0000000000000936.

  PMID: 25760659 BACKGROUND

• Jones C, Backman C, Capuzzo M, Egerod I, Flaatten H, Granja C, Rylander C, Griffiths RD; RACHEL group. Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. 2010;14(5):R168. doi: 10.1186/cc9260. Epub 2010 Sep 15.

  PMID: 20843344 BACKGROUND

• Myhren H, Ekeberg O, Toien K, Karlsson S, Stokland O. Posttraumatic stress, anxiety and depression symptoms in patients during the first year post intensive care unit discharge. Crit Care. 2010;14(1):R14. doi: 10.1186/cc8870. Epub 2010 Feb 8.

  PMID: 20144193 BACKGROUND

• Jensen JF, Thomsen T, Overgaard D, Bestle MH, Christensen D, Egerod I. Erratum to: Impact of follow-up consultations for ICU survivors on post-ICU syndrome: a systematic review and meta-analysis. Intensive Care Med. 2015 Jul;41(7):1391. doi: 10.1007/s00134-015-3932-9. No abstract available.

  PMID: 26104120 BACKGROUND

• Davydow DS, Kohen R, Hough CL, Tracy JH, Zatzick D, Katon WJ. A pilot investigation of the association of genetic polymorphisms regulating corticotrophin-releasing hormone with posttraumatic stress and depressive symptoms in medical-surgical intensive care unit survivors. J Crit Care. 2014 Feb;29(1):101-6. doi: 10.1016/j.jcrc.2013.08.016. Epub 2013 Sep 24.

  PMID: 24075295 BACKGROUND

• Jones C, Backman C, Griffiths RD. Intensive care diaries and relatives' symptoms of posttraumatic stress disorder after critical illness: a pilot study. Am J Crit Care. 2012 May;21(3):172-6. doi: 10.4037/ajcc2012569.

  PMID: 22549573 BACKGROUND

• Knowles RE, Tarrier N. Evaluation of the effect of prospective patient diaries on emotional well-being in intensive care unit survivors: a randomized controlled trial. Crit Care Med. 2009 Jan;37(1):184-91. doi: 10.1097/CCM.0b013e31819287f7.

  PMID: 19050634 BACKGROUND

• Jones C, Griffiths RD, Humphris G, Skirrow PM. Memory, delusions, and the development of acute posttraumatic stress disorder-related symptoms after intensive care. Crit Care Med. 2001 Mar;29(3):573-80. doi: 10.1097/00003246-200103000-00019.

  PMID: 11373423 BACKGROUND

• Karnatovskaia LV, Johnson MM, Benzo RP, Gajic O. The spectrum of psychocognitive morbidity in the critically ill: a review of the literature and call for improvement. J Crit Care. 2015 Feb;30(1):130-7. doi: 10.1016/j.jcrc.2014.09.024. Epub 2014 Oct 2.

  PMID: 25449881 BACKGROUND

• Bergbom I, Svensson C, Berggren E, Kamsula M. Patients' and relatives' opinions and feelings about diaries kept by nurses in an intensive care unit: pilot study. Intensive Crit Care Nurs. 1999 Aug;15(4):185-91. doi: 10.1016/s0964-3397(99)80069-x.

  PMID: 10786503 BACKGROUND

• Ullman AJ, Aitken LM, Rattray J, Kenardy J, Le Brocque R, MacGillivray S, Hull AM. Diaries for recovery from critical illness. Cochrane Database Syst Rev. 2014 Dec 9;2014(12):CD010468. doi: 10.1002/14651858.CD010468.pub2.

  PMID: 25488158 BACKGROUND

• 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 BACKGROUND

• Sayde GE, Stefanescu A, Conrad E, Nielsen N, Hammer R. Implementing an intensive care unit (ICU) diary program at a large academic medical center: Results from a randomized control trial evaluating psychological morbidity associated with critical illness. Gen Hosp Psychiatry. 2020 Sep-Oct;66:96-102. doi: 10.1016/j.genhosppsych.2020.06.017. Epub 2020 Jul 2.

  PMID: 32763640 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Narrative Medicine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Narration; Communication; Behavior

Study Officials

• Rachel Hammer, MD, MFA

  Tulane University School of Medicine

  PRINCIPAL INVESTIGATOR

• George Sayde, MD, MPH

  Tulane University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: March 12, 2020
• Study Start: September 26, 2017
• Primary Completion: September 25, 2018
• Study Completion: September 1, 2020
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)