Intensive Care Unit Conflict Mediation Study ("GIRAFFE")

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

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*

Study Overview

• Status: Not yet recruiting
• Conditions: Aggression; Workplace Violence; Critical Care Staff
• Intervention / Treatment: Behavioral: SEM DESTINO

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

-family members of patients or intensive care unit staff

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Structured Conflict Management Program; All participants will be part of a single arm titled "Structured Conflict Management Program". The intervention is an organizational and behavioral program that introduces a Conflict Mediation Team and a Singular Care Plan Committee in the intensive care unit, grounded in nonviolent communication. 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.

Behavioral: SEM DESTINO; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
-conflict index	the rate of significant conflicts per 100 ICU admissions.	12 months
Prevalence of post-traumatic stress symptoms in ICU family member	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.	6 months after ICU discharge

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: Instituto D'Or de Pesquisa

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: critical care; Aggression; Workplace violence
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Aggression
• Other Study ID Numbers: 68567898809090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: sensible data HIPPA ACT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No