Diaries for Critically Ill Patients Written by Relatives

November 17, 2017 updated by: Anne Højager Nielsen, Hospitalsenheden Vest

Dagbøger Til Kritisk Syge Patienter Skrevet af pårørende: Betydning for Patient og pårørende Samt Effekt i Forhold Til Udvikling af Symptomer på Posttraumatisk Stress

This study will investigate the effect of diaries written by relatives for critically ill patients on the risk of posttraumatic stress symptoms.

Utilizing a randomized controlled design pairs of one patient and one relative will be assigned to either diary intervention or standard care. The effect of the diary will be evaluated using a questionnaire 3 months post charge.

The results of this study will add to the body of knowledge on how diaries may help critical care survivors and their relatives to proceed with their lives.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diaries written for critically ill patients has previously been shown to protect patient and relatives from new cases of post traumatic stress (Jones et al. 2010, Jones et al. 2012, Garrouste-Orgeas 2012). Furthermore it has been described how relatives and patients use diaries written by nurses to process the time they stayed in the intensive care unit (Egerod et al. 2011). This study will investigate if there is a similar effect, when relatives write the diary for the critically ill patient instead of nurses doing it as patients find it very valuable when relatives has contributed to the diary or when relatives presence has been documented in the diary (Engström et al. 2009).

The investigators hypothesis is that a diary written by relatives for critically ill patients will reduce the risk of developing symptoms of post traumatic stress in relatives and patients.

Design: randomized controlled study. Relative and patient are randomized as a pair to either intervention group (diary intervention) or control group (standard care). Relatives will be recruited to the study while the patient is critically ill in the ICU, the patient will be recruited when he or she is able to receive information about the study.

Intervention: Nurses guide the nearest relative (spouse, partner, child, parent or friend) to write a diary during the patients stay in the ICU and up to a month post discharge. The diary is a notebook which also contains a written instruction on how to write and use the diary during and after the time in the intensive care unit. At least two photographs of the patient is taken by the staff and added to the diary upon the patients consent.

Blinding: Due to the nature of the intervention neither caregivers nor participants can be blinded to the intervention. However, steps will be taken to ensure that the outcomes assessor is blinded.

Setting: the study will take place in the two ICUs (10 bed and 7 beds respectively) of the hospital unit Hospitalsenheden Vest, a 441 bed hospital serving 300.000 citizens. Both ICUs are mixed medical/surgical units.

Primary outcome: Risk of post traumatic stress symptoms (PTSS-14 (Twigg et al 2008).

Secondary outcomes: Anxiety and depressionsymptoms (HADS (Zigmond and Snaith 1983)) and general physical and psychological wellbeeing (SF-36 (Bjorner et al. 1998)).

Baseline data: To compare groups the following parameters will be recorded on all eligible patients. Patients: age, sex, education, marital status, diagnosis, SAPS-II score (Le Gall et al. 1993), hours on ventilator, LOS-ICU. Furthermore the following data will be recorded on participating relatives: age, sex, relation to patient, education and working status.

Sample size: Based on findings from a previous study (1) where the median PTSS-14 score was 24 (SD 12), alfa 5% and beta 80% and a minimal relevant difference of 4 points, 71 relative-patient pairs needs to be included in each group. To compensate for dropouts due to critical illness and death, 100 pairs will be included in each group. The data collection period is anticipated to last 24 months.

Follow-up: 3 months post ICU discharge all participants receive a questionnaire to be completed and returned by mail or email.

Statistical analysis will cover a comparison of mean and median values in the two study groups, supplemented by a stratified analysis to estimate risk reduction. Parametric and non-parametric test will be applied according to the nature of data.

Dissemination: Results, positive, negative or inconclusive will be published in an international peer-reviewed journal.

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Midtjylland
      • Herning, Region Midtjylland, Denmark, 7400
        • Regionshospitalet Herning
      • Holstebro, Region Midtjylland, Denmark, 7500
        • Regionshospitalet Holstebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients:

  • Expected to stay in ICU > 48 hours
  • Expected to be on ventilator > 24 hours
  • Has a close relative > 18 years old
  • Speaking and understanding Danish.
  • Expected to be able to deliver an informed consent later

Relative:

*Speaking and understanding Danish

Relative and patient are included in the study as a pair.

Exclusion Criteria:

  • Patient staying less than 48 hours in ICU
  • Patient less than 24 hours on ventilator
  • Patient not able to give an informed consent to participate in study or patient dies in ICU (both relative and patient are excluded).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

Relatives randomized to the intervention group is provied with a diary. Nurses advice relatives on how to write and use the diary under and after the patients stay in the ICU. A written description on how to use the diary is also provided.

At least two photographs of the patient is taken by nurses. Photographs will first be included in the diary when full consent from the patient has been obtained.

Patients and relatives recieve a questionaire 3 months after the patient has been dismissed from the ICU.
Other: Diary

The intervention is a notebook in which the relative will be asked to keep a diary of the time when the patient is critically ill in the ICU. At least two photos of the patient will be added to the diary upon full consent from the patient.

The diary contains a written description on how to use the diary during and after the patients stay in the ICU.
No Intervention: Control group
Standard Care. Patients and relatives recieve a questionaire 3 months after the patient has been dismissed from the ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSS-14 (Post Traumatic Stress Symptoms)
Time Frame: 3 months post discharge from ICU
14 items inventory covering all symptoms of PTSD.
3 months post discharge from ICU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HADS (Hospital Anxiety and Depression Scale)
Time Frame: 3 months post discharge from ICU
14 items inventory assessing symptoms of anxiety and depression.
3 months post discharge from ICU
SF-36
Time Frame: 3 months post discharge from ICU
36 items inventory covering the general physical and psychological wellbeing of an individual.
3 months post discharge from ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospitalsenheden Vest

Collaborators

University of Aarhus

Investigators

  • Principal Investigator: Anne H Nielsen, RN, MCN, Hospitalsenheden Vest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2015

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 5, 2015

First Posted (Estimate)

February 6, 2015

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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