Clinical trial NCT04163497: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Post Intensive Care Unit Syndrome
Intensive Care Unit Syndrome
PTSD
Anxiety Symptoms
Depressive Symptoms
Lead sponsor: Hospital Ernesto Dornelles
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Posttraumatic Stress Disorder (PTSD)
timeFrame: 1 week after ICU discharge
measure: Posttraumatic Stress Disorder (PTSD)
timeFrame: 1 month after ICU discharge
measure: Posttraumatic Stress Disorder (PTSD)
timeFrame: 3 months after ICU discharge
Secondary outcomes:
measure: Anxiety
timeFrame: 1 week, 1 month and 3 months after ICU discharge
measure: Depression
timeFrame: 1 week, 1 month and 3 months after ICU discharge
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Juliana Mara Stormovski de Andrade
state: RS
Study officials:
References: