NCT07621874

Brief Summary

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\*

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Oct 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

May 18, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Aggressioncritical careWorkplace violence

Outcome Measures

Primary Outcomes (2)

  • -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

Study Arms (1)

Structured Conflict Management Program

EXPERIMENTAL

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

Interventions

SEM DESTINOBEHAVIORAL

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

Structured Conflict Management Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
-family members of patients or intensive care unit staff

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

June 2, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

sensible data HIPPA ACT