Increasing Family Engagement in Critical Care

NCT06586528 | Recruiting

• 1 other identifier: 2025-4301
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• FAMily Engagement (FAME) score within 1 week of ICU discharge

  The FAMily Engagement (FAME) tool is a self-administered 12-item questionnaire that assesses an individual's current engagement practice. FAME uses a five-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree), and scale results are changed to a 0-100 scoring system, with higher scores indicating greater engagement in care. The following subdomains are evaluated: engagement perception, family presence, communication, education, decision-making, care contribution, and family needs. FAME includes the following engagement domains: family presence, family needs, communication and education, decision making, and direct care. FAME also captures the following family-centered care principles: dignity and respect, information sharing, participation, and collaboration.

  1-week post-hospital discharge

Secondary Outcomes (6)

• Family satisfaction in the ICU (FS-ICU)

  1-week post-hospital discharge

• Quality of communication (QOC score)

  1-week post-hospital discharge

• Anxiety and depression (HADS)

  1-week post-hospital discharge

• Anxiety and depression (HADS)

  6 months post-hospital discharge

• Post-traumatic stress (IES-Revised)

  6 months post-hospital discharge

Study Arms (2)

Control Group: Usual Care

NO INTERVENTION

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

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

Other: NGAGE tool

Interventions

NGAGE tool OTHER

Access to NGAGE tool

Intervention Group: Access to NGAGE Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lady Davis Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

Study Officials

• Michael J Goldfarb, MD, MSc

  Lady Davis Institute, McGill University, Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jillian Kifell, MSc

CONTACT

5143408222; jillian.kifell.ccomtl@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Staff, Division of Cardiology

Model Details: In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: March 26, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)