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

Not Applicable

Recruiting

• Conditions: Psychosocial Intervention; Intensive Care Units (ICUs); Psychosocial Health

• Registration Number: NCT06733493
• Lead Sponsor: Harald Gündel

Brief Summary

This Pilot-RCT is part of a feasibility study that aims to learn if the IPS-psychosocial care intervention and an RCT on its efficacy are feasible in patients, relatives and staff on icu wards. The Pilot-RCT will examine outcomes, that might indicate an improvement in psychosocial safety climate and other health- and wellbeing-related measures due to the administration of the intervention that is described in the following. The main question the Pilot-RCT aims to answer is:

Is there evidence that the IPS intervention improves the psychosocial safety climate and other components of psychosocial well-being in ICU teams, patients and their relatives?

Researchers will compare four intervention groups (icu wards with implementation of the IPS-Intervention) with four control groups (icu wards with regular supply of psychosocial care) to see if the comparison of two groups in this RCT is feasible.

The IPS-Intervention consists of a ward psychologist who works as part of the ICU team and takes care of the staff, patients and relatives in accordance to the intervention manual that was developed in a prior phase of this project.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

• Affiliation to one of the 8 participating ICU wards during the duration of the study, either by: occupation as a healthcare professional, admission as a patient, relation to an admitted patient

Exclusion Criteria

• Age under 18 years old
• Inability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Psychosocial Safety Climate	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 PSC-4 scale (Formazin, Ertel, Kersten, \& Nübling, 2022)
Intention to leave	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)
Perceived Wellbeing	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 wellbeing index (Brähler, Mühlan, Albani, \& Schmidt, 2005)
Health-related quality of life	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)
Perceived Stress	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 (Klein, Brähler, Dreier, Reinecke, Müller, Schmutzer, Wölfling, \& Beutel, 2016)
Depression / Anxiety	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)
Work-related consequences of strain	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)
Self-efficacy, optimism and pessimism	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)
Team cohesion at work	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)

Trial Locations

Locations (4)

Clinic of Psychosomatic Medicine and Psychotherapy, University Hospital Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany

Psychosomatic Medicine and Psychosomatic Therapy, Medical Faculty University Hospital Magdeburg; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany

Institute of Social Medicine and Health Systems Research (ISMHSR); 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany

Medical Clinic - Department of Psychosomatic Medicine of the Charité; 🇩🇪 Berlin, Germany