Intensive Care Unit (ICU) Diary Project

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04305353
• Other study ID #: ICU Diary RCT NOLA
• Secondary ID: GH-17-022
• Status: Completed
• Phase: N/A
• Start date: September 26, 2017
• Est. completion date: September 1, 2020

Study information

• Verified date: April 2021
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators compared the efficacy of the ICU diary, prospectively written by third-parties during the patient's intensive care course, versus education-alone, on reducing acute PTSD symptoms after discharge. Patients with an ICU stay greater than 72 hours, and who were intubated and mechanically ventilated over 24 hours, were recruited and randomized to either receive a diary at bedside with psychoeducation, or psychoeducation alone. Intervention patients received their ICU diary within the first week of admission into the intensive care unit. Psychometric testing with IES-R, PHQ-8, HADS and GAD-7 was conducted at weeks 4, 12, and 24 after ICU discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 1, 2020
• Est. primary completion date: September 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Post ICU Syndrome
• PTSD
• Syndrome

Intervention

Other:
• Diary (blank journal) plus PTSD psycho-education
A blank journal where a prospective account of a patient's ICU course (everyday events) can be documented by family members and healthcare providers
• PTSD psycho-education alone
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.

Locations

Country	Name	City	State
United States	Tulane University School of Medicine	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University School of Medicine	The Arnold P. Gold Foundation

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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, Bretonnière C, Lautrette A, Badié 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. — View Citation

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. — View Citation

Jones C, Bäckman 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. — View Citation

Jones C, Bäckman 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Myhren H, Ekeberg O, Tøien 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. — View Citation

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. Review. — View Citation

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;(12):CD010468. doi: 10.1002/14651858.CD010468.pub2. Review. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Hospital-associated Depression and Anxiety symptoms	Hospital Anxiety and Depression Scale (HADS), range of 0-21 for either anxiety or depression subscores, with higher scores corresponding to worse outcomes. Scores of 0-7 are normal, 8-10 are borderline abnormal (mild depression or anxiety), and 11-21 correspond to severe symptoms of anxiety or depression.	at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Secondary	Change in Depression symptoms	Patient Health Questionnaire (PHQ-8), score ranges 0-24, as higher scores correspond to worse depression symptoms. Scores of 5-10 represent mild symptoms of depression, 10-15 signal moderate symptoms, and 15-24 correspond to severe symptoms.	at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Secondary	Change in Anxiety symptoms	Generalized Anxiety Disorder 7-item scores (GAD-7) range from 0 to 21, with higher scores corresponding to worse anxiety symptoms. Scores of 0-4 indicate minimal anxiety, 5-9 correspond to mild anxiety, 10-14 signal moderate anxiety, and 15-21 represent severe anxiety.	at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge