Pilot program for psychosocial care in intensive care units
Integrated Psychosocial Care in Intensive Care: Piloting of an Innovative Care Approach (IPS Pilot) - Study Protocol for a Pilot Randomized Controlled Trial
This study is testing whether adding a psychologist to the care team in intensive care units can improve the well-being of patients, their families, and healthcare staff compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 375 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Ulm Academic / other |
| Locations | 4 sites (Ulm, Baden-Württemberg and 3 other locations) |
| Trial ID | NCT06733493 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to assess the feasibility of an integrated psychosocial care intervention in intensive care units (ICUs). The study will compare outcomes between ICU wards implementing the IPS intervention, which includes a ward psychologist as part of the team, and control wards receiving standard psychosocial care. The primary focus is to evaluate improvements in psychosocial safety climate and overall well-being for patients, their relatives, and healthcare staff. By examining these outcomes, the trial seeks to determine if the intervention can be effectively integrated into ICU settings.
Who should consider this trial
Good fit: Ideal candidates include patients admitted to participating ICU wards, their relatives, and healthcare professionals working in those units.
Not a fit: Patients who are under 18 years old or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance the psychosocial well-being of patients and healthcare providers in intensive care settings.
How similar studies have performed: While similar psychosocial interventions have been explored, this specific approach is novel in the context of intensive care units.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ulm, Baden-Württemberg and 3 other locations
- Clinic of Psychosomatic Medicine and Psychotherapy, University Hospital Ulm — Ulm, Baden-Württemberg, Germany (Recruiting)
- Psychosomatic Medicine and Psychosomatic Therapy, Medical Faculty University Hospital Magdeburg — Magdeburg, Sachsen-Anhalt, Germany (Recruiting)
- Institute of Social Medicine and Health Systems Research (ISMHSR) — Magdeburg, Sachsen-Anhalt, Germany (Active_not_recruiting)
- Medical Clinic - Department of Psychosomatic Medicine of the Charité — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Harald Gündel, Prof. Dr. med. — Clinic of Psychosomatic Medicine and Psychotherapy, University Hospital Ulm,
- Study coordinator: Sophie Felizitas Nickel, M.Sc. Psych.
- Email: sophie.nickel@uniklinik-ulm.de
- Phone: +49 731 500 61957
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.