Study Protocol for a Pilot Randomized Controlled Trial of a Psychosocial Care Intervention in Intensive Care

Primary outcomes

1. Psychosocial Safety Climate

   Time frame: Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment)

   Psychosocial Safety Climate as perceived by ICU staff in the experimental and control group, measured with the German version of the Psychosocial Safety Climate (PSC-4) scale (Formazin, Ertel, Kersten, & Nübling, 2022). 4 items (eg. "Senior management shows support for stress prevention through involvement and commitment") ranked on a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree). A higher sum score of the 4 items (Min = 4, Max = 20) indicates a more positive psychosocial safety climate

2. Intention to leave

   Time frame: Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment)

   Healthcare Professionals' Intention to leave their workplace, profession or reduce their working time, measured with the questions from the Nurses Early Exit (NEXT) study (Simon, Tackenberg, Hasselhorn, Kümmerling, Büscher, & Müller, 2005). 3 items ranked on a 5-point Likert-scale. A higher sum score (Min=3, Max=15) indicates a higher turnover intention.

3. Perceived Wellbeing

   Time frame: Healthcare Professionals: Baseline and Follow-Up; Relatives: Baseline and Follow-Up; Patients: 4 months after ICU stay

   Healthcare professionals', patients', and relatives' perceived well-being, measured with the german version of the WHO-5 (World Health Organization-Five) wellbeing index (Brähler, Mühlan, Albani, & Schmidt, 2005). 5 items rated on a 6-point Likert scale ranging from 0 (At no time) to 5 (All of the time). Higher overall sumscores (Min=0, Max=25) indicate better well-being.

4. Health-related quality of life

   Time frame: Healthcare Professionals: Baseline and Follow-Up; Relatives: Baseline and Follow-Up; Patients: 4 months after ICU stay

   Healthcare professionals', patients', and relatives' perceived health-related quality of life, measured with the german version of the Short-Form Health-Related Survey (SF-12, Drixler, Morfeld, Glaesmer, Brähler, Wirtz, 2020). 12 items with a mixed response format (2-6 options) that can be assigned to the Physical Component Summary (PCS) and Mental Component Summary (MCS). PCS and MCS are standardized (Mean = 50, SD = 10). Higher scores indicate better physical or mental health-related quality of life.

5. Perceived Stress

   Time frame: Healthcare Professionals: Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment); Relatives: Baseline (during first 8 months of treatment, individually: during or up to 4 weeks after ICU admission), Follow-Up: 4 months after Base

   Healthcare professionals', patients' and relatives' perception of stress, measured with the german version of the Perceived Stress Scale (PSS-10, Klein, Brähler, Dreier, Reinecke, Müller, Schmutzer, Wölfling, & Beutel, 2016). 10 items that are rated on a 5-point Likert scale from 0 (Never) to 4 (Very often). Higher total scores (Min=0, Max=40) reflect higher perceived stress.

6. Depression / Anxiety

   Time frame: Healthcare Professionals: Baseline and Follow-Up; Relatives: Baseline and Follow-Up; Patients: 4 months after ICU stay

   Healthcare professionals', patients', and relatives' perceived depressive and anxiety symptoms, measured with the german version of the patient health questionnaire (PHQ-4, Löwe, 2015). 4 items rated on a 4-point Likert scale from 0 (Not at all) to 3 (Nearly every day). Higher total scores (Min=0, Max=12) indicate more severe psychological distress.

7. Work-related consequences of strain

   Time frame: Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment)

   Emotional and cognitive irritation as perceived by ICU staff in the experimental and control group, measured with the irritation scale to measure consequencey of work-related strain (Mohr, Rigotti, & Müller, 2007). 8 items rated on a 7-point Likert scale from 1 (Strongly disagree) to 7 (Strongly agree). Higher total scores for the overall irritation scale (Min=8, Max=56), Emotional Irritation subscale (5 items, Min=5, Max=35) and Cognitive Irritation (3 items, Min=3, Max=21) indicate higher levels of irritation.

8. Self-efficacy, optimism and pessimism

   Time frame: Healthcare Professionals: Baseline and Follow-Up; Relatives: Baseline and Follow-Up; Patients: 4 months after ICU stay

   Healthcare professionals', patients', and relatives' perceived self-efficacy, optimism and pessimism measured with the german self-efficacy, optimism and pessimism questionnaire (SWOP-K9, Scholler, Fliege, & Klapp, 1999). 9 items rated on a 4-point scale from 1 (Does not apply at all) to 4 (Applies completely) and are divided into the subscales self-efficacy, optimism and pessimism. Higher subscale means (Min=1, Max=4) for self-efficacy and optimism indicate better psychological resources; higher pessimism subscale means indicate worse outcomes.

9. Team cohesion at work

   Time frame: Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment)

   Team cohesion in the ICU as perceived by ICU staff in the experimental and control group, measured with the Erlangen Team Cohesion at work scale (ETC, Lieb, Erim, & Morawa, 2024). 13 items rated on a 5-point Likert scale (1 = Strongly disagree, 5 = Strongly agree) and can be divided into the subsales Collegial Solidarity and Unity and Problem Management. A higher overall sum score (Min=13, Max=65) or higher subscale means (Min=1, Max=5) indicate stronger team cohesion.