NCT02067559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

October 25, 2018

Status Verified

May 1, 2017

Enrollment Period

2.7 years

First QC Date

February 18, 2014

Last Update Submit

October 23, 2018

Conditions

Stress Disorders, Post TraumaticAnxietyDepressionQuality of Life

Keywords

Post Traumatic Stress DisorderPTSDIntensive Care UnitICU

Outcome Measures

Primary Outcomes (1)

  • Feasibility - enrollment of 1-2 participants per month

    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).

    One year

Secondary Outcomes (3)

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

    90 days

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

    30 and 90 days post ICU Discharge

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

    30 days post ICU discharge

Study Arms (4)

ICU Diaries

EXPERIMENTAL

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. Instructions will be provided to the patient's family at the time of randomization and will be available at the bedside for reference. Staff instructions will be posted at charting area for staff. During the patient's stay in ICU, the diary will never leave the unit. Under no circumstances will any part of an ICU diary be duplicated. Research staff will take a photograph of the patient after consent is obtained and the photograph will be mounted on the first page of the diary. Photographs will be taken with a Polaroid camera; therefore there will be no other record of the photograph.

Behavioral: ICU Diary

Psychoeducation

EXPERIMENTAL

The research nurse will provide a psychoeducational brochure to study participants at ICU discharge (if cognitive capacity is established) or 30 days after ICU discharge. If participants are not well enough 30 days post-discharge, they will be assessed every two weeks by research staff until the brochure is given to them. The 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. The document will also be mailed to the participant's follow-up physician.

Behavioral: Psychoeducation

ICU Diary plus Psychoeducation

EXPERIMENTAL

Participants will receive both ICU diary and psychoeducation interventions, with both documents provided at ICU-discharge, or 30 days post-discharge as above.

Behavioral: ICU DiaryBehavioral: Psychoeducation

Treatment as Usual

NO INTERVENTION

No additional intervention to usual ICU care will be given.

Interventions

ICU DiaryBEHAVIORAL

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).

ICU DiariesICU Diary plus Psychoeducation
PsychoeducationBEHAVIORAL

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.

ICU Diary plus PsychoeducationPsychoeducation

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (7)

  • 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.

    PMID: 18774425BACKGROUND

  • 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.

    PMID: 17384929BACKGROUND

  • 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.

    PMID: 11396288BACKGROUND

  • 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: 20843344BACKGROUND

  • 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: 22549573BACKGROUND

  • 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.

    PMID: 12961065BACKGROUND

  • 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.

    PMID: 30119073DERIVED

Related Links

MeSH Terms

Conditions

Combat DisordersAnxiety DisordersDepressionStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Marcus R Blouw, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 20, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

October 25, 2018

Record last verified: 2017-05

Locations

CA(1)