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

Stress Disorders, Post Traumatic research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Stress Disorders, Post Traumatic

Anxiety

Depression

Quality of Life

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:ICU DiaryCreation 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).

Behavioral:PsychoeducationThe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ICU DiariesA 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.

PsychoeducationThe 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.

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

Treatment as UsualNo additional intervention to usual ICU care will be given.

Study Status

Completed

Start Date: March 2014

Completed Date: November 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Feasibility

Secondary Outcome: Efficacy

Study sponsors, principal investigator, and references

Principal Investigator: Marcus R Blouw, MD

Lead Sponsor: University of Manitoba

Collaborator: Manitoba Medical Service Foundation

More information:https://clinicaltrials.gov/show/NCT02067559

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. Review.

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