ICU Diaries and Its Effects After the Unit Discharge

PTSD Clinical Trial

Official title:

Patient Experience: ICU Diaries and Its Effects After the Unit Discharge

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04163497
• Other study ID #: 3.011.427
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: September 9, 2020

Study information

• Verified date: November 2019
• Source: Hospital Ernesto Dornelles
• Contact: Juliana Andrade
• Phone: +55 51 993094059
• Email: diariouti[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: September 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Symptoms
• Depression
• Depressive Symptoms
• Intensive Care Unit Syndrome
• Post Intensive Care Unit Syndrome
• PTSD
• Syndrome

Intervention

Device:
• ICU Diaries
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.

Locations

Country	Name	City	State
Brazil	Juliana Mara Stormovski de Andrade	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Ernesto Dornelles

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week after ICU discharge
Primary	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.	1 month after ICU discharge
Primary	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.	3 months after ICU discharge
Secondary	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.	1 week, 1 month and 3 months after ICU discharge
Secondary	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.	1 week, 1 month and 3 months after ICU discharge