Clinical trial NCT06733493: Study Protocol for a Pilot Randomized Controlled Trial of a Psychosocial Care Intervention in Intensive Care
Official title: Integrated Psychosocial Care in Intensive Care: Piloting of an Innovative Care Approach (IPS Pilot) - Study Protocol for a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosocial Intervention
Intensive Care Units (ICUs)
Psychosocial Health
Keywords: health services research
psychosocial intervention
health personnel
INTENSIVE CARE UNIT
Critical Care
Lead sponsor: University Hospital Ulm
Sponsor class: OTHER
Collaborators: name: Institute of Social Medicine and Health Systems Research, University Hospital Magdeburg
name: University Hospital Berlin Charite
name: Magdeburg University Hospital, Germany
First posted: 2024-12-13
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center study on 3 sites and 8 ICU wards, with cluster-randomization of intervention (n=4) and control wards (n=4).

Data-collection in a mixed design:

* Between-subject factor: Affiliation to intervention or control ICU ward
* Between-subject factor: Affiliation to the group of healthcare professionals, relatives or patients
* Within-subject factor: Time of data collection (baseline or follow-up)
* Healthcare professionals: baseline (first 6 weeks of treatment) and follow-up (last 6 weeks of treatment)
* Relatives: baseline (during treatment of their patient in the ICU and up to 4 weeks after), follow-up (4 months after completing baseline)
* Patients: No baseline data-collection since this would produce a biased sample (only mildly impaired ICU patients), follow-up (4 months after ICU stay)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Psychosocial Safety Climate
timeFrame: Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment)
measure: Intention to leave
timeFrame: Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment)
measure: Perceived Wellbeing
timeFrame: Healthcare Professionals: Baseline and Follow-Up; Relatives: Baseline and Follow-Up; Patients: 4 months after ICU stay
measure: Health-related quality of life
timeFrame: Healthcare Professionals: Baseline and Follow-Up; Relatives: Baseline and Follow-Up; Patients: 4 months after ICU stay
measure: Perceived Stress
timeFrame: 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
measure: Depression / Anxiety
timeFrame: Healthcare Professionals: Baseline and Follow-Up; Relatives: Baseline and Follow-Up; Patients: 4 months after ICU stay
measure: Work-related consequences of strain
timeFrame: Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment)
measure: Self-efficacy, optimism and pessimism
timeFrame: Healthcare Professionals: Baseline and Follow-Up; Relatives: Baseline and Follow-Up; Patients: 4 months after ICU stay
measure: Team cohesion at work
timeFrame: Baseline (first 6 weeks of treatment) and Follow-Up (last 6 weeks of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Clinic of Psychosomatic Medicine and Psychotherapy, University Hospital Ulm
state: Baden-Württemberg
city: Magdeburg
country: Germany
facility: Psychosomatic Medicine and Psychosomatic Therapy, Medical Faculty University Hospital Magdeburg
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Institute of Social Medicine and Health Systems Research (ISMHSR)
state: Sachsen-Anhalt
city: Berlin
country: Germany
facility: Medical Clinic - Department of Psychosomatic Medicine of the Charité
Study officials:
affiliation: Clinic of Psychosomatic Medicine and Psychotherapy, University Hospital Ulm,
name: Harald Gündel, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nickel SF, Korger S, Schindler W, et al. Integrated Psychosocial Care in Intensive Care (IPS-Pilot): Study Protocol of Phase A of the Systematic Development and Pilot Testing of a Complex Intervention (Preprint). 2024