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ICU Diaries and Its Effects After the Unit Discharge

Primary Purpose

Post Intensive Care Unit Syndrome, Intensive Care Unit Syndrome, PTSD

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
ICU Diaries
Sponsored by
Hospital Ernesto Dornelles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Intensive Care Unit Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Will be included in this study ICU patients, older than 18 years old who are on mechanical ventilation, whose family members accept the participation by signing the consent form.

Exclusion Criteria:

  • remain in the ICU for less than 72 hours;
  • require mechanical ventilation for less than 24 hours;
  • have limiting neurological symptoms (such as previous dementia);
  • have a diagnosis of PTSD prior to hospitalization;
  • have severe cognitive impairment at ICU discharge;
  • not participate in all stages of the study, or whose outcome is death.

Sites / Locations

  • Juliana Mara Stormovski de AndradeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diary reading

No diary reading

Arm Description

Outcomes

Primary Outcome Measures

Posttraumatic Stress Disorder (PTSD)
number of patients with PTSD assessed by Posttraumatic Stress Disorder Checklist (PCL-5) - PCL-5 A 20-item selfreport measure designed to assess the DSM-5 symptoms of PTSD. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (questions 1-5), 1 Criterion C item (questions 6-7), 2 Criterion D items (questions 8-14), 2 Criterion E items (questions 15-20). According the authors, a PCL-5 cut-point of 33 it's a reasonable value to use for provisional PTSD diagnosis.
Posttraumatic Stress Disorder (PTSD)
number of patients with PTSD assessed by Posttraumatic Stress Disorder Checklist (PCL-5) - PCL-5 A 20-item selfreport measure designed to assess the DSM-5 symptoms of PTSD. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (questions 1-5), 1 Criterion C item (questions 6-7), 2 Criterion D items (questions 8-14), 2 Criterion E items (questions 15-20). According the authors, a PCL-5 cut-point of 33 it's a reasonable value to use for provisional PTSD diagnosis.
Posttraumatic Stress Disorder (PTSD)
number of patients with PTSD assessed by Posttraumatic Stress Disorder Checklist (PCL-5) - PCL-5 A 20-item selfreport measure designed to assess the DSM-5 symptoms of PTSD. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (questions 1-5), 1 Criterion C item (questions 6-7), 2 Criterion D items (questions 8-14), 2 Criterion E items (questions 15-20). According the authors, a PCL-5 cut-point of 33 it's a reasonable value to use for provisional PTSD diagnosis.

Secondary Outcome Measures

Anxiety
number of patients with anxiety symptoms assessed by Hospital Anxiety and Depression Scale (HADS) - A self-assesment scale composed of 14 items rated on a 4-point Likert scale ranging from 0 to 3, with 5 of the 14 items reversed scored. Items from each of the 7-item anxiety and depression subscales are summed to give total subscale scores ranging from 0 to 21, with higher scores indicating higher levels of anxiety and depression.The cutoff points suggested by the authors were adopted: no anxiety from 0 to 8, with anxiety ≥ 9; no depression from 0 to 8, with depression ≥ 9.
Depression
number of patients with depression symptoms assessed by Hospital Anxiety and Depression Scale (HADS) - A self-assesment scale composed of 14 items rated on a 4-point Likert scale ranging from 0 to 3, with 5 of the 14 items reversed scored. Items from each of the 7-item anxiety and depression subscales are summed to give total subscale scores ranging from 0 to 21, with higher scores indicating higher levels of anxiety and depression.The cutoff points suggested by the authors were adopted: no anxiety from 0 to 8, with anxiety ≥ 9; no depression from 0 to 8, with depression ≥ 9.

Full Information

First Posted
July 31, 2019
Last Updated
November 12, 2019
Sponsor
Hospital Ernesto Dornelles
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1. Study Identification

Unique Protocol Identification Number
NCT04163497
Brief Title
ICU Diaries and Its Effects After the Unit Discharge
Official Title
Patient Experience: ICU Diaries and Its Effects After the Unit Discharge
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
March 9, 2020 (Anticipated)
Study Completion Date
September 9, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Ernesto Dornelles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The preparation of ICU Diary, conducted by the Hospital care team towards the patient, has been suggested as an effective and low-cost strategy to enhance the patient's experience in the intensive care unit, as well as to prevent anxiety, depression and Posttraumatic Stress Disorder (PTSD). New-found researches in Brazilian ICUs indicates the pervasiveness of these symptoms in patients who have been hospitalized in the unit, however, there are no randomized trials that evaluate the impact of Diaries in the Brazilian context. The aim is to explore the effects of providing an ICU Diary in the symptoms of anxiety, depression and PTSD within patients who were hospitalized in the unit. Refers to a randomized controlled trial that is being conducted in two ICUs in a general-purpose hospital in Porto Alegre, Brazil.
Detailed Description
The Diaries will be filled voluntarily by the professionals who provide the patient care - psychologists, nutritionists, nursing technicians, nurses, physicians and physiotherapists. In addition, the patient's family members who wish to participate and collaborate with the Diaries may ask anyone on the team to assist them. The Diaries will be available at the bedside and may be filled with objective and subjective data on the patient's clinical condition and daily evolution, as well as remarkable events. Examples of entries possibilities are messages, pictures, drawings, photographs, thoughts, sayings, and wishes. Photographic records aim to provide the patient memories of the environment and of his advances in treatment. They will be attached to the Diary only if the patient wishes. The predicted sample is composed of 102 intensive care patients, aged above 18 years old, that require mechanical ventilation and remained in the ICU more than 72 hours. All patients who meet the inclusion criteria will have their Diary drawn up by the team and will be randomized one week after discharge from the ICU. All patients will have their memory assessed at 1 week deadline after critical care discharge, and at this moment, the intervention patients will receive their ICU Diary along with psychological support. One month after the ICU discharge, all the patients will be evaluated by phone and checked in symptoms of depression, anxiety and Posttraumatic Stress Disorder (PSTD). The final assessment of the development of the symptoms will be at the deadline of 3 months.The patients in the control group will be invited to withdraw their Diary after the end of the survey. In case of readmission in the ICU, in a period less than 72h of discharge, the Diary used will be reactivated. In cases of death, the researchers will offer the responsible parent the opportunity to receive the Diary. During this period, the Diaries will be stored by the researchers confidentially, in a previously defined location.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Intensive Care Unit Syndrome, Intensive Care Unit Syndrome, PTSD, Anxiety Symptoms, Depressive Symptoms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
The finaly analysis, by the statistician will be masking.
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diary reading
Arm Type
Experimental
Arm Title
No diary reading
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
ICU Diaries
Intervention Description
To explore the effects of providing an ICU Diary in the symptoms of anxiety, depression and PTSD within patients who were hospitalized in the unit.
Primary Outcome Measure Information:
Title
Posttraumatic Stress Disorder (PTSD)
Description
number of patients with PTSD assessed by Posttraumatic Stress Disorder Checklist (PCL-5) - PCL-5 A 20-item selfreport measure designed to assess the DSM-5 symptoms of PTSD. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (questions 1-5), 1 Criterion C item (questions 6-7), 2 Criterion D items (questions 8-14), 2 Criterion E items (questions 15-20). According the authors, a PCL-5 cut-point of 33 it's a reasonable value to use for provisional PTSD diagnosis.
Time Frame
1 week after ICU discharge
Title
Posttraumatic Stress Disorder (PTSD)
Description
number of patients with PTSD assessed by Posttraumatic Stress Disorder Checklist (PCL-5) - PCL-5 A 20-item selfreport measure designed to assess the DSM-5 symptoms of PTSD. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (questions 1-5), 1 Criterion C item (questions 6-7), 2 Criterion D items (questions 8-14), 2 Criterion E items (questions 15-20). According the authors, a PCL-5 cut-point of 33 it's a reasonable value to use for provisional PTSD diagnosis.
Time Frame
1 month after ICU discharge
Title
Posttraumatic Stress Disorder (PTSD)
Description
number of patients with PTSD assessed by Posttraumatic Stress Disorder Checklist (PCL-5) - PCL-5 A 20-item selfreport measure designed to assess the DSM-5 symptoms of PTSD. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (questions 1-5), 1 Criterion C item (questions 6-7), 2 Criterion D items (questions 8-14), 2 Criterion E items (questions 15-20). According the authors, a PCL-5 cut-point of 33 it's a reasonable value to use for provisional PTSD diagnosis.
Time Frame
3 months after ICU discharge
Secondary Outcome Measure Information:
Title
Anxiety
Description
number of patients with anxiety symptoms assessed by Hospital Anxiety and Depression Scale (HADS) - A self-assesment scale composed of 14 items rated on a 4-point Likert scale ranging from 0 to 3, with 5 of the 14 items reversed scored. Items from each of the 7-item anxiety and depression subscales are summed to give total subscale scores ranging from 0 to 21, with higher scores indicating higher levels of anxiety and depression.The cutoff points suggested by the authors were adopted: no anxiety from 0 to 8, with anxiety ≥ 9; no depression from 0 to 8, with depression ≥ 9.
Time Frame
1 week, 1 month and 3 months after ICU discharge
Title
Depression
Description
number of patients with depression symptoms assessed by Hospital Anxiety and Depression Scale (HADS) - A self-assesment scale composed of 14 items rated on a 4-point Likert scale ranging from 0 to 3, with 5 of the 14 items reversed scored. Items from each of the 7-item anxiety and depression subscales are summed to give total subscale scores ranging from 0 to 21, with higher scores indicating higher levels of anxiety and depression.The cutoff points suggested by the authors were adopted: no anxiety from 0 to 8, with anxiety ≥ 9; no depression from 0 to 8, with depression ≥ 9.
Time Frame
1 week, 1 month and 3 months after ICU discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Will be included in this study ICU patients, older than 18 years old who are on mechanical ventilation, whose family members accept the participation by signing the consent form. Exclusion Criteria: remain in the ICU for less than 72 hours; require mechanical ventilation for less than 24 hours; have limiting neurological symptoms (such as previous dementia); have a diagnosis of PTSD prior to hospitalization; have severe cognitive impairment at ICU discharge; not participate in all stages of the study, or whose outcome is death.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana Andrade
Phone
+55 51 993094059
Email
diariouti@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bárbara Rech
Phone
+55 51 984148510
Email
barbara.rech@gmail.com
Facility Information:
Facility Name
Juliana Mara Stormovski de Andrade
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90160091
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana Mara Andrade
Phone
5551984148510
Email
jstorma@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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ICU Diaries and Its Effects After the Unit Discharge

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