Improving Family Engagement in Acute Cardiovascular Care: the NGAGE Trial (NGAGE)

Real-Time Feedback to Improve Family Engagement in Acute Cardiovascular Care

The objective of this study is to assess if the NGAGE real-time feedback tool improves family engagement in family members of people admitted to an acute cardiac care unit

The investigators will randomize 88 family members of people hospitalized in the acute cardiac ward in a 1:1 manner to either the NGAGE intervention or usual care. Family members will be eligible if the expected unit stay of their loved one is >48 hours and if they can communicate in English or French. A family member is considered anyone with a biological, emotional, or legal relationship with the patient whom the patient wishes to be involved in their care. The primary outcome of the study will be the FAMily Engagement (FAME) score at hospital discharge. Secondary outcomes will be family mental health (by HADS score) and family care satisfaction (by FS-ICU score).

Study Overview

• Status: Completed
• Conditions: Family Engagement
• Intervention / Treatment: Other: NGAGE tool

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T1E2
      • Ladis Davis Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Family member of CV patient with expected stay > 48 hours (as per treating team)
• Aged of at least 18 years old
• Ability to communicate in English or French
• Willing to fill out the questionnaires as per the study

Exclusion Criteria:

• Expected stay of < 48 hours
• Inability to communicate in English or French

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Non-Intervention; Will receive usual care standards.
Experimental: NGAGE tool group; Will have access to the NGAGE tool to learn about engaging in care and to request engagement activities.	Other: NGAGE tool; Will have access to the NGAGE tool to learn about engaging in care and to request engagement activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family Engagement (FAME) score	An engagement score that measures the following domains: family presence, family needs, communication and education, decision making, and direct care. Family-centered care principles are also captured such as dignity and respect, information sharing, participation and collaboration. The score is continuous and ranges from 0 to 100, with higher scores indicating increased levels of care engagement.	Within 48-hours of hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental health	The Hospital Anxiety and Depression Scale (HADS) is a self-reported tool to measure anxiety and depression. Scores range from 0-14 with higher scores indicating increased levels of anxiety and depression.	Within 48-hours of hospital discharge
Family satisfaction	The Family Satisfaction in the Intensive Care Unit (FS-ICU) tool is used to assess the family satisfaction and experience with care in the ICU. Scores range from 0-100 with higher scores indicating increased family satisfaction.	Within 48-hours of hospital discharge

Collaborators and Investigators

• Sponsor: Lady Davis Institute
• Investigators: Principal Investigator: Michael Goldfarb, MD, MSc, Lady Davis Institute, McGill University, Jewish General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: July 2, 2023
• First Submitted That Met QC Criteria: July 2, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2023-3590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No