Recruiting

NGAGE Tool

Sponsor:

Lady Davis Institute

Code:

NCT06586528

Conditions

Family Engagement

Critical Care, Intensive Care

Patient and Family Engagement

Health Care Delivery

Family-centered Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NGAGE tool

Study Details

Brief 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.

Conditions

Family Engagement

Critical Care, Intensive Care

Patient and Family Engagement

Health Care Delivery

Family-centered Care

Study ID

NCT06586528

Start date

Mar 26, 2025

Status verified date

May, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

194 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Control Group: Usual Care

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.

experimental: Intervention Group: Access to NGAGE Tool

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

Interventions

NGAGE tool

Access to NGAGE tool

Primary outcome measure

  • FAMily Engagement (FAME) score within 1 week of ICU discharge [ Time Frame: 1-week post-hospital discharge ]

Central Contacts and Locations

Central contacts

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada

Contacts

Principal Investigator:

Michael J Goldfarb, MD, MSc

Jewish General Hospital

Recruiting

Montréal, Quebec, Canada

Contacts

Principal Investigator:

Michael J Goldfarb, MD, MSc

More Information

Sponsor

Lady Davis Institute

Last update posted

May 18, 2025

Last verified

May, 2025

Keywords

  • Patient- and Family-Centered Care
  • Family Engagement
  • Critical Care
  • Intensive Care Unit
  • Person-Centered Care
  • Delivery of Health Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lady Davis Institute on 2025-05-18.