Improving Family Engagement in Acute Cardiovascular Care: The NGAGE Trial

Study Overview
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Brief Summary
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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).

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

Conditions
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Family Engagement

Intervention / Treatment
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* Other: NGAGE tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |