Increasing Family Engagement in Critical Care (NGAGE)

Lady Davis Institute

Status: Enrolling

Conditions: Health Care Delivery; Family-centered Care; Patient and Family Engagement; Critical Care, Intensive Care; Family Engagement

Treatments: Other: NGAGE tool

Study type: Interventional

Funder types: Other

Identifiers

NCT06586528

2025-4301

Details and patient eligibility

About

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.

Enrollment: 194 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult family members (age ≥ 18 years) of ICU patients
• Expected ICU stay ≥ 48 hours
• Able to participate in English or French

Exclusion criteria

• Family members who do not wish to participate in care
• Repeat admissions within the study period
• Another family member has already participated in the study

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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194 participants in 2 patient groups

Control Group: Usual Care

No Intervention group

Description:

Participants in the control group will not receive access to the NGAGE tool. Participants will be able to engage in care as per current family engagement practices at each site.

Intervention Group: Access to NGAGE Tool

Experimental group

Description:

Participants in the intervention group will be provided access to the NGAGE tool.

Treatment:

Other: NGAGE tool