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NCT Number: NCT07621874

Intensive Care Unit Conflict Mediation Study

To evaluate the impact of a structured, multidisciplinary conflict management program incorporating an interprofessional Singular Care Plan *PAS* Committee and a Conflict Mediation Team on the incidence and severity of conflicts, family satisfaction, and staff well-being in an adult intensive care unit *ICU*

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The allocation is non randomized because the intervention is implemented at the level of the intensive care unit and cannot ethically or practically be restricted to a subset of patients or staff. The masking status is open label, as it is not feasible to blind staff or families to the presence of a conflict mediator or the convening of a committee. The primary purpose of the study is health services research, specifically the evaluation of an institutional policy for conflict management and its impact on conflict dynamics, safety and experience in critical care.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

-family members of patients or intensive care unit staff

Treatment and study plan

SEM DESTINO

Behavioral

The Conflict Mediation Team is composed of trained facilitators who can be activated by any assistential collaborator when a conflict in progress exceeds the collaborator's capacity to manage it. The Singular Care Plan Committee is convened by the facilitator in complex cases that require broader, interprofessional analysis and the elaboration of a documented care plan based on the SEM DESTINO mnemonic

Primary outcomes

  1. -conflict index

    Time frame: 12 months

    the rate of significant conflicts per 100 ICU admissions.

  2. Prevalence of post-traumatic stress symptoms in ICU family member

    Time frame: 6 months after ICU discharge

    Proportion of ICU family members with post-traumatic stress symptoms, defined as an Impact of Event Scale-6 (IES-6) mean item score > 1.75, assessed 6 months after ICU discharge of the index patient.

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Instituto D'Or de Pesquisa

Registry information

Official study title

A Multidisciplinary Framework for ICU Conflict Mediation: Rationale and Methodological Approach to Enhancing Safety and Care Quality

Acronym: "GIRAFFE"

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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