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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Psychosocial Intervention Intensive Care Units (ICUs) Psychosocial Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participating Healthcare-professionals can not be fully masked, since they are aware of the new team member in form of a ward psychologist (intervention) or aware that a ward psychologist was employed in another ward (control). Yet they are not aware about key efficacy components of the intervention (as the team integration, mere presence, ...)

Study Groups

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IPS-Intervention Group

Implementation of a trained ward psychologist for 12 months, supporting patients, relatives and staff according to the IPS-intervention manual

Group Type EXPERIMENTAL

No interventions assigned to this group

Control Group: Standard Care

No intervention will be admitted. ICU wards receive the usual care, e.g. consiliary psychological service, optional consultation for staff

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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integrated psychosocial care

Employment of a psychologist in psychotherapeutic training as a member of the multiprofessional team at the ICU ward for the duration of one year. Tasks: Psychosocial Support for staff, patients and their relatives.

Intervention Type BEHAVIORAL

Other Intervention Names

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IPS-intervention ward psychologist IPS study therapist IPS study psychologist

Eligibility Criteria

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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