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Completed

NCT Number: NCT02067559

Preventing Post-traumatic Stress in ICU Survivors: A Pilot Randomized Controlled Trial of ICU Diaries

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.

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Key information

Conditions

Stress Disorders, Post Traumatic Anxiety Anxiety Disorders Behavior Behavioral Symptoms Combat Disorders Depression Mental Disorders Quality of Life Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICU Diary

Behavioral

Creation of an ICU diary: A bound empty journal will be stored at the patient's bedside near the nurse charting area. All family members and ICU staff are invited to write in the ICU diary at any time. Procedure for diary writing will follow previous research (see www.icu-diary.org).

Psychoeducation

Behavioral

The psychoeducation brochure will describe procedures in the ICU (sedation, ventilation), and the delirium, hallucinations, and trauma that may result; as well as symptoms of PTSD post-ICU. It will provide instructions for follow-up, information, and emergency care. The brochure will instruct participants to contact their follow-up healthcare provider if they have any questions.

Primary outcomes

  1. Feasibility - enrollment of 1-2 participants per month

    Time frame: One year

    To test the feasibility of ICU diaries in a Canadian ICU setting by asking nurses and family members about the process of creating the diary.

    Specifically, feasibility of diary will be determined by a survey about the usability, time spent, and general comments on using the diary. Surveys will be filled by each individual making a diary entry (visitors and hospital staff).

Secondary outcomes

  1. Efficacy at 90 days as determined by Impact of Event Scores (IES-R)

    Time frame: 90 days

    The investigators will measure patients' Impact of Event Scores - Revised (IES-R) at 90 days post-ICU discharge. These scores will be compared across the four intervention groups (ICU Diaries, Psychoeducation, ICU Diary + Psychoeducation, Treatment as Usual).

  2. Change in IES-R 30 days post ICU discharge and access to follow up care at 90 days post ICU discharge

    Time frame: 30 and 90 days post ICU Discharge

    The investigators will measure differences (across treatment groups) between participant's Impact of Event Scores (IES-R) at 30 days post-discharge, and proportion of participants accessing follow-up care (psychiatric, psychological, primary care) at 90 days post-ICU discharge.

    The investigators will also assess anxiety, depression, quality of life scores, and social support scores 30 and 90 days post-ICU discharge, and measure the associations between these factors and the ICU Memory Tool (ICUMT) scores.

  3. IES-R score of family member at 30 days post patient ICU discharge

    Time frame: 30 days post ICU discharge

    The investigators will assess family members of the discharged patient for IES-R scores at 30 days post-patient discharge.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Manitoba Medical Service Foundation

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 20, 2014
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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