Improving Family Engagement in Acute Cardiovascular Care: The NGAGE Trial

Family Engagement Clinical Trial

— NGAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939427
• Other study ID #: 2023-3590
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2023
• Source: Lady Davis Institute
• Contact: Chella Price, BSc
• Phone: 15143408222
• Email: chella.price.ccomtl[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Family Engagement

Intervention

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

Locations

Country	Name	City	State
Canada	Ladis Davis Institute	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Lady Davis Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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