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

NCT02067559 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2018-10-25

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

ICU Diary

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).

BEHAVIORAL

Psychoeducation

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.

Sponsors & Collaborators

  • Manitoba Medical Service Foundation

    collaborator OTHER

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Marcus R Blouw, MD · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02067559 on ClinicalTrials.gov