Feasibility of an App to Measure Patient Stressors in an Intensive Care Unit (ICU Feel Better App)- a Before-and-after Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility of an App to Measure Patient Stressors During Treatment in an Intensive Care Unit (ICU Feel Better App)- a Before-and-after Study

Conditions
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Delirium

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated in an ICU Duration of treatment ≥48h Age: 18 years and older Male, female, or divers gender Exclusion Criteria: Poor language skills Statement in patient letter or living will that excludes participation Participation in another prospective treatment study with indication delirium Refusal of participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard Group<br>Cohort of n=20 intensive care unit patients from the ages of 18 years will be collected. Participants of this cohort will not use the ICU Feel Better App. | |
| Experimental Group<br>Cohort of n=20 intensive care unit patients from the ages of 18 years will be collected. Participants of this cohort will have the opportunity to use the ICU Feel Better App every day from the second day after admission to the ICU until the day of discharge from ICU. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 until discharge from the intensive care unit, an expected average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental distress | Mental distress is measured by Patient Health Questionnaire 4 [PHQ-4, range: 0-12, higher scores indicate higher distress] | 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 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 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 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 until discharge from the intensive care unit, an expected average of 10 days | 
| Incidence of delirium | Incidence of delirium is measured by CAM-ICU twice per day until | 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 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 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 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 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 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 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 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 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. | 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 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 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 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 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 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 until discharge from the intensive care unit, an expected average of 10 days |