RecruitingNot ApplicableNCT06586528

Increasing Family Engagement in Critical Care

Increasing Family Engagement in Critical Care: The NGAGE Trial (The NGAGE Trial)


Sponsor

Lady Davis Institute

Enrollment

194 participants

Start Date

Mar 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The primary aim of this trial is to evaluate if the NGAGE tool improves care engagement in family members of ICU patients. The secondary objectives are to assess if the NGAGE tool improves communication, care satisfaction, psychological symptoms, and quality of life in family members of ICU patients. The NGAGE trial is a stepped wedge cluster randomized trial of 6 Canadian adult ICUs, involving 194 family members. A family member will be considered anyone with a biological, emotional, or legal relationship with the patient and whom the patient wishes to be involved in their care. There will be random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The intervention group will have access to the NGAGE tool, which has modules to Learn, Engage, and Report. "Engage" allows the family member to indicate their desired engagement activity, which is then transmitted to the treating healthcare team to provide the requested activity. "Learn" contains educational capsules about the ICU environment and information about care participation. "Report" allows the family member to provide real-time feedback to the healthcare team. The primary endpoint is the FAMily Engagement (FAME) score within 1 week of ICU discharge. Secondary endpoints are family-centered outcomes, including communication quality, satisfaction, and mental health (anxiety and depression) scores within 1 week of ICU discharge, and quality of life and mental health (anxiety, depression, and post-traumatic distress symptoms) at 6 months. The mean difference of the validated FAME score, a continuous variable, will be compared between groups.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The NGAGE trial is testing a digital tool designed to help family members of patients in intensive care units (ICUs) become more engaged in their loved one's care, improving communication with healthcare teams, satisfaction, and mental health outcomes. The NGAGE tool has three components: a learning module about the ICU environment, an engagement module where family members can request specific care participation activities, and a reporting module for real-time feedback to clinical staff. Adult family members (18 or older) of ICU patients expected to remain in the ICU for at least 48 hours, who are able to participate in English or French, are eligible to join. Participation involves using the NGAGE digital tool during the ICU stay and completing questionnaires at discharge and at 6 months afterward. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNGAGE tool

Access to NGAGE tool


Locations(2)

Jewish General Hospital

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

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NCT06586528


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