Family Support Intervention in Intensive Care Units

Summary

Background: Family members of critically ill patients face considerable uncertainty and distress during their close other's intensive care unit (ICU) stay, with about 20-60% of family members experiencing post-traumatic distress post-ICU. Guidelines recommend structured family inclusion, communication, and support, but the existing evidence base around protocolized family support interventions is modest and requires substantiation.

Methods: To test the clinical effectiveness and explore the implementation of a multicomponent, nurse-led family support intervention in ICUs, the investigators will undertake a parallel, cluster-randomized, controlled, multicenter superiority hybrid-type 1 trial. The trial will include eight clusters (ICUs) per study arm, with a projected total sample size of 896 family members of adult, critically ill patients treated in the German-speaking part of Switzerland. The trial targets family members of critically ill patients with an expected ICU stay of 48 hours or longer. Families in the control arm will receive usual care. Families in the intervention arm, in addition to usual care, will receive a family support intervention consisting of specialist nurse support along the patient pathway at defined time-points, including follow-up care, and nurse-coordinated liaison and structured, interprofessional communication by the ICU team. The primary study endpoint is quality of family care, operationalized as family members' satisfaction with ICU care at discharge. Secondary endpoints include quality of communication and nurse support, family management of critical illness (functioning, resilience), and family members' mental health (well-being, psychological distress) measured at admission, discharge, and after three, six, and twelve months. Data of all participants, regardless of protocol adherence, will be analyzed using linear mixed-effects models, with the individual participant as the unit of inference.

Discussion: The FICUS trial will establish the effectiveness of the family support intervention and generate knowledge of its implementability. Both types of evidence are necessary to determine whether the intervention works as intended in clinical practice and whether an effective intervention could be scaled-up to other ICUs. The study findings will make a significant contribution to the current body of knowledge on effective ICU care that promotes family participation and well-being.

Conditions

• Postintensive Care Syndrome
• Family Members
• Quality of Life
• Depression, Anxiety
• Posttraumatic Stress Disorder
• Family Dynamics

Interventions

OTHER

Family Support Intervention (FSI)

In addition to usual care, families in the intervention group will receive (1) specialist nurse support along the patient pathway at defined time-points, from admission to discharge including follow-up care, and (2) nurse-coordinated liaison and structured, interprofessional communication by the ICU team. The intervention is grounded in a family systems approach and guideline-based strategies for family engagement in the ICU and has been pilot-tested in one ICU.

Sponsors & Collaborators

• Swiss National Science Foundation

  collaborator OTHER

• Rahel Naef

  lead OTHER

Principal Investigators

• Rahel Naef, PhD, RN · University of Zurich

• Miodrag Filipovic, MD · Cantonal Hospital St. Gallen

• Marie-Madlen Jeitziner, PhD, RN · University Hospital Bern, Inselspital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-12

Primary Completion

2024-03-31

Completion

2024-12-31

Countries

• Switzerland

Study Locations