Improving Family Engagement in Acute Cardiovascular Care: The NGAGE Trial

Sponsor

Lady Davis Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05939427

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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

We 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).

Condition or Disease	Intervention/Treatment	Phase
Family Engagement	Other: NGAGE tool	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Intervention 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.
No Intervention: Non-Intervention Will receive usual care standards.

Arm

Intervention/Treatment

Experimental: Experimental: Intervention

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.

No Intervention: Non-Intervention

Will receive usual care standards.

Outcome Measures

Primary Outcome Measures

FAMily Engagement (FAME) Score [Within 48-hours of hospital discharge]
An engagement score that measures the following domains: family presence, family needs, communication and education, decision making, and direct care. Family-centered care principales are also captured such as dignity and respect, information sharing, participation and collaboration.

Secondary Outcome Measures

Mental Health (HADS) Score [Within 48-hours of hospital discharge]
The Hospital Anxiety and Depression Scale is a self-reported tool to measure anxiety and depression.
Family Care Satisfaction (FS-ICU) Score [Within 48-hours of hospital discharge]
This tool is used to assess the family satisfaction and experience with care in the ICU.
Change in FAME Score During Admission [Within 48-hours of hospital discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ladis Davis Institute	Montréal	Quebec	Canada	H3T1E2

Sponsors and Collaborators

Lady Davis Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Goldfarb, Clinician-Investigator, Lady Davis Institute

ClinicalTrials.gov Identifier:

NCT05939427

Other Study ID Numbers:

2023-3590

First Posted:

Jul 11, 2023

Last Update Posted:

Jul 11, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 11, 2023