This study examines the feasibility and efficacy of a mobile application (app), which enables critically ill patients to report perceived patient stressors to their caregivers.
For many critically ill patients, treatment in an intensive care unit (ICU) is very stressful, and for some of the patients it is a traumatic experience. The domains of patient stressors encompass physical stressors, mental health stressors, communication stressors, and environmental stressors. The experience of stressors during ICU is associated with a higher risk of worse outcomes including delirium, delayed recovery, and post-intensive care syndrome (PICS). In the context of inpatient intensive care medicine, health care professionals (HCP) have problems to correctly rate the extent of their patients' stress. In this study, we examine the feasibility and efficacy of a stressor-reporting system based on a mobile application (app), which allows critically ill patients to evaluate by themselves the intensity of their stressors, and thus, to communicate their stress experience to HCPs. In the first assessment phase of this study, outcome data of a cohort of n=20 patients will be collected (cohort A). Participants of cohort A will not use the ICU Feel Better App. In the second phase, outcome data of another n=20 patients (cohort B) will be collected. Participants of cohort B will have the opportunity to use the ICU Feel Better App from the second day after admission to the ICU until the day of discharge from ICU.
Study Type
OBSERVATIONAL
Enrollment
46
Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin
Berlin, Germany
Patient reported perceived severity of patient stressors
Patient reported perceived severity of patient stressors (Mean score of patient stressor list ). Range: 0-4, higher scores indicate higher stress. At day 2 or 3 of ICU treatment (before first use of the app) (t1), and at the day before or the day of discharge from ICU (t2).
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Mental distress
Mental distress is measured by Patient Health Questionnaire 4 \[PHQ-4, range: 0-12, higher scores indicate higher distress\]
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Acute perceived stress
Acute perceived stress is measured by Stress Thermometer (range: 0-10, higher scores indicate higher stress)
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
State anxiety
State anxiety is measured with the Faces Anxiety Scale \[FAS, range: 1-5, higher scores indicate higher anxiety\]
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Pain
Pain is measured with the Faces Pain Scale (range: 0-10, higher scores indicate higher pain)
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Self-reported cognitive functioning
Self-reported cognitive functioning is measured with a list of problems of cognitive functions (range: 0-4, higher scores indicate worse cognitive functioning)
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
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Incidence of delirium
Incidence of delirium is measured by CAM-ICU twice per day until
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Length of stay
Length of stay is measured in days.
Time frame: Time until discharge from hospital, an expected average of 20 days
Length of intensive care unit stay
Length of intensive care unit stay is measured in days.
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Duration of mechanical ventilation
Duration of mechanical ventilation is measured in hours.
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
APACHE II-Score
APACHE II score is measured by the Acute Physiology and Chronic Health Evaluation System II.
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Medication
Medication is measured by data retrieved from the patient data management system.
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Treatment
Treatment is measured by data retrieved from the patient data management system.
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Diagnoses
Diagnoses are measured by ICD-10 codes retrieved from the patient data management system.
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Mode of intensive care unit admission
Mode of intensive care unit admission is measured by admission data retrieved from the patient data management system.
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Diagnosis of post-intensive care syndrome (PICS)
Diagnosis of PICS is measured by an extensive clinical examination.
Time frame: Up to one month
Log data per patient
Process data of app use: Log data per patient measured from start to end of app use
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Stressor intensity-
Process data of app use: Stressor intensity measured from start to end of app use
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Support of study personal
Number of app use trials with assistance of study personnel.
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Acceptance of app
Patient reported acceptance of app use, daily until the end of app use
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Usability of app
Patient reported usability of app, daily until the end of app use
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days
Relevance and understandability of app stressor items
Patient reported relevance and understandability of app stressor items until the end of app use
Time frame: Time until discharge from the intensive care unit, an expected average of 10 days