Clinical trial NCT02067559: Preventing Post-traumatic Stress in ICU Survivors: A Pilot Randomized Controlled Trial of ICU Diaries
Official title: Preventing Post-traumatic Stress in ICU Survivors: A Pilot Randomized Controlled Trial of ICU Diaries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post Traumatic
Anxiety
Depression
Quality of Life
Keywords: Post Traumatic Stress Disorder
PTSD
Intensive Care Unit
ICU
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Medical Service Foundation
First posted: 2014-02-20
Enrollment: 59
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of the study is to test the feasibility of the ICU diaries intervention in the ICU. The investigators do not have sufficient power to detect differences in the hypotheses below, but will use the present pilot study to inform sample size required to adequately power a follow-up randomized control trial.

(1) The investigators hypothesize that subjects exposed to a psychoeducation condition will have reduced rates of post-traumatic stress disorder (PTSD) compared to those experiencing treatment as usual (TAU). (2) The investigators hypothesize that compared to participants in the psychoeducation and TAU groups, those subjects exposed to an ICU diary, and those exposed to both ICU diary + psychoeducation conditions, will have significantly reduced rates of PTSD at follow-up. (3)The investigators hypothesize that participants exposed to the ICU diary + psychoeducation condition will have significantly lower rates of PTSD compared to those in the ICU diary alone condition.

Detailed description: This is a randomized controlled pilot study involving patients who are in the ICU, for a minimum of 72 hrs with \> 24 hrs mechanical ventilation. As is common in ICU research, proxy consent will be obtained from family members upon ICU admission. Patients will be randomized to 4 different conditions (1) treatment as usual (TAU) (2) ICU diary (3) psychoeducation (4) ICU diary + psychoeducation. The ICU diary will be created and maintained by nurses and family members for each patient randomized to condition (2) and (4), and will be given to patients by a research nurse upon discharge from the ICU. The patients in conditions (3) and (4) will receive a psychoeducational brochure detailing general treatment and sedation patients receive in the ICU, and the psychological symptoms such as depression and PTSD that can occur after a stay in the ICU. This brochure will also be sent to their follow-up physician. Patients in all conditions will be assessed at one week post-ICU for recollection of delusional memories using ICU Memory Tool (ICUMT), at one- and three-month post-ICU for baseline PTSD symptoms using Impact of Events Scale-Revised (IES-R), a commonly used measure of PTSD symptomatology, as well as measures of anxiety/depression, social support, and general health. At one and three month follow-up, the investigators will also ask patients if they had contact with their health care providers/follow-up physicians, sought mental health treatment, their general impressions of the intervention they received (diary, psychoeducation, both), and whether/how often they reviewed the document (if in conditions 2-4). The investigators will ascertain feasibility from the health care provider and family perspective by appending a short questionnaire to the diary, to be filled out each time an entry is made.

Eligibility criteria: Inclusion Criteria:

* age greater than 17 years
* enrolment within 72 hours of ICU admission
* time of ICU stay is predicted to be \>72 hours by ICU treatment team
* greater than 24 hours mechanical ventilation required
* understand verbal and written English

Exclusion Criteria:

* no caregiver/family available
* terminal illness with life expectancy of less than 6 months
* pre-existing cognitive impairment
* less than 24 hours of mechanical ventilation
* reason for ICU admission is suicide attempt / overdose

Primary outcomes:
measure: Feasibility - enrollment of 1-2 participants per month
timeFrame: One year
Secondary outcomes:
measure: Efficacy at 90 days as determined by Impact of Event Scores (IES-R)
timeFrame: 90 days
measure: Change in IES-R 30 days post ICU discharge and access to follow up care at 90 days post ICU discharge
timeFrame: 30 and 90 days post ICU Discharge
measure: IES-R score of family member at 30 days post patient ICU discharge
timeFrame: 30 days post ICU discharge
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Marcus R Blouw, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davydow DS, Gifford JM, Desai SV, Needham DM, Bienvenu OJ. Posttraumatic stress disorder in general intensive care unit survivors: a systematic review. Gen Hosp Psychiatry. 2008 Sep-Oct;30(5):421-34. doi: 10.1016/j.genhosppsych.2008.05.006. Epub 2008 Jul 30.
citation: Jones C, Backman C, Capuzzo M, Flaatten H, Rylander C, Griffiths RD. Precipitants of post-traumatic stress disorder following intensive care: a hypothesis generating study of diversity in care. Intensive Care Med. 2007 Jun;33(6):978-85. doi: 10.1007/s00134-007-0600-8. Epub 2007 Mar 24.
citation: Backman CG, Walther SM. Use of a personal diary written on the ICU during critical illness. Intensive Care Med. 2001 Feb;27(2):426-9. doi: 10.1007/s001340000692.
citation: 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.
citation: 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.
citation: Cuthbertson BH, Hull A, Strachan M, Scott J. Post-traumatic stress disorder after critical illness requiring general intensive care. Intensive Care Med. 2004 Mar;30(3):450-5. doi: 10.1007/s00134-003-2004-8. Epub 2003 Sep 5.
citation: Kredentser MS, Blouw M, Marten N, Sareen J, Bienvenu OJ, Ryu J, Beatie BE, Logsetty S, Graff LA, Eggertson S, Sweatman S, Debroni B, Cianflone N, Arora RC, Zarychanski R, Olafson K. Preventing Posttraumatic Stress in ICU Survivors: A Single-Center Pilot Randomized Controlled Trial of ICU Diaries and Psychoeducation. Crit Care Med. 2018 Dec;46(12):1914-1922. doi: 10.1097/CCM.0000000000003367.