Improving Family Engagement in Acute Cardiovascular Care: The NGAGE Trial

NCT05939427 | Completed

• 1 other identifier: 2023-3590
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Family Engagement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mental health

  Within 48-hours of hospital discharge

• Family satisfaction

  Within 48-hours of hospital discharge

Study Arms (2)

NGAGE tool group

EXPERIMENTAL

Will have access to the NGAGE tool to learn about engaging in care and to request engagement activities.

Other: NGAGE tool

Non-Intervention

NO INTERVENTION

Will receive usual care standards.

Interventions

NGAGE tool OTHER

Will have access to the NGAGE tool to learn about engaging in care and to request engagement activities.

NGAGE tool group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (1)

Ladis Davis Institute

Montreal, Quebec, H3T1E2, Canada

Location

Study Officials

• Michael Goldfarb, MD, MSc

  Lady Davis Institute, McGill University, Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Investigator

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: July 11, 2023
• Study Start: April 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)