Clinical trial NCT06586528: Increasing Family Engagement in Critical Care
Official title: Increasing Family Engagement in Critical Care: The NGAGE Trial (The NGAGE Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-09-19
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: FAMily Engagement (FAME) score within 1 week of ICU discharge
timeFrame: 1-week post-hospital discharge
Secondary outcomes:
measure: Family satisfaction in the ICU (FS-ICU)
timeFrame: 1-week post-hospital discharge
measure: Quality of communication (QOC score)
timeFrame: 1-week post-hospital discharge
measure: Anxiety and depression (HADS)
timeFrame: 1-week post-hospital discharge
measure: Anxiety and depression (HADS)
timeFrame: 6 months post-hospital discharge
measure: Post-traumatic stress (IES-Revised)
timeFrame: 6 months post-hospital discharge
measure: Quality of life (EuroQOL-5D-5L score)
timeFrame: 6 months post-hospital discharge
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Lady Davis Institute, McGill University, Jewish General Hospital
name: Michael J Goldfarb, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: