NGAGE Tool for Family Engagement

(NGAGE Trial)

Recruiting at 2 trial locations

Overseen By Jillian Kifell, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lady Davis Institute

Disqualifiers: Non-participation in care, Repeat admissions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

194 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called NGAGE, designed to involve family members of ICU patients more in their loved one's care. The researchers aim to determine if NGAGE can improve family communication with healthcare teams and increase satisfaction with the care their loved ones receive. The trial also examines whether NGAGE can reduce stress, anxiety, and depression in family members. Participants must be adults related to someone in the ICU for at least 48 hours and able to speak English or French. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance family involvement in ICU care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the NGAGE tool is safe for family engagement in ICU settings?

Research shows that the NGAGE tool helps family members become more involved in patient care. Testing with families in other studies has shown that it increases their involvement in the care process. Importantly, no reports of harmful effects have emerged from using the NGAGE tool, suggesting it is safe for family members. While it enhances family engagement, it does not appear to cause any problems or risks for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NGAGE tool because it offers a fresh approach to family engagement in healthcare settings. Unlike standard practices that rely on traditional methods of communication and involvement, the NGAGE tool aims to enhance family participation by providing structured and interactive support. This tool could lead to more effective collaboration between families and healthcare providers, potentially resulting in better health outcomes. By focusing on active engagement, NGAGE could transform how families contribute to and participate in the care process.

What evidence suggests that the NGAGE tool is effective for improving family engagement in ICU care?

Research has shown that the NGAGE tool might help family members become more involved in patient care. An initial study found that 69% of family members used the tool, indicating its practicality for everyday use. In this trial, participants in the intervention group will receive access to the NGAGE tool, enabling families to share their care preferences with healthcare teams, potentially enhancing their involvement in care. Participants in the control group will not have access to the NGAGE tool and will engage in care according to current family engagement practices. While these results are encouraging, further testing is needed to confirm its effectiveness in various situations. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael J Goldfarb, MD, MSc

Principal Investigator

Lady Davis Institute, McGill University, Jewish General Hospital

Are You a Good Fit for This Trial?

This trial is for adult family members (age ≥ 18 years) of ICU patients expected to stay in the ICU for at least 48 hours. Participants must be able to engage in English or French. It's designed to see if a tool called NGAGE can help them get more involved in their loved one's care.

Inclusion Criteria

I am expected to stay in the ICU for at least 48 hours.

I am an adult family member of someone in the ICU.

I can communicate in English or French.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Phase

Participants receive usual care without access to the NGAGE tool

Varies

Intervention Phase

Participants in the intervention group are provided access to the NGAGE tool, which includes modules to Learn, Engage, and Report

Varies

Follow-up

Participants are monitored for family engagement, communication quality, satisfaction, and mental health outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• NGAGE tool

Trial Overview

The NGAGE tool, which aims to improve family engagement with ICU patient care, is being tested. The study will measure how well it helps families learn about the ICU, participate in care decisions, and report feedback using modules within the tool.

How Is the Trial Designed?

Group I: Intervention Group: Access to NGAGE Tool Experimental Treatment 1 Intervention

Participants in the intervention group will be provided access to the NGAGE tool.

Group II: Control Group: Usual Care Active Control 1 Intervention

Participants in the control group will not receive access to the NGAGE tool. Participants will be able to engage in care as per current family engagement practices at each site.

Who Is Running the Clinical Trial?

Lady Davis Institute

Lead Sponsor

Trials

50

Recruited

6,600+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

The 'Caring Connection' is a web-based resource aimed at supporting caregivers of children with cancer by providing personalized clinical information and facilitating communication between families and healthcare providers.

Insights from structured interviews with caregivers and healthcare providers, along with user testing of the website prototype, are guiding the ongoing development to ensure it meets the specific information needs of families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring Connection: developing an Internet resource for family caregivers of children with cancer. Lewis, D., Gunawardena, S., Harrison, JH., et al.[2016]

A study involving 40 participants from nine hospitals identified four key themes essential for enhancing patient and family engagement (PE) in healthcare: resources, training, organizational commitment, and staff support.

Despite the recognition of PE's benefits, hospitals often lack dedicated funding and compensation for patient/family advisors, highlighting a critical barrier to effective engagement that needs further research and improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organizational capacity for patient and family engagement in hospital planning and improvement: interviews with patient/family advisors, managers and clinicians. Anderson, NN., Baker, GR., Moody, L., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12198593/

A Digital Tool to Improve Family Engagement in Acute Care

NGAGE is a digital tool designed to empower families to increase their engagement in patient care, allowing them to communicate requests to the healthcare team.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772963X25003680

Family Engagement in Cardiac Intensive Care and Patient ...

The NGAGE trial was a prospective pilot randomized controlled trial of 88 family members of cardiac ICU and ward patients at an academic ...

3.

onlinecjc.ca

onlinecjc.ca/article/S0828-282X(24)00845-6/fulltext

IMPROVING FAMILY ENGAGEMENT IN ACUTE ...

The data supports the feasibility of the NGAGE tool and intervention. The results will inform the design of a multi-center effectiveness trial of the NGAGE tool ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40586017/

A Digital Tool to Improve Family Engagement in Acute Care

The NGAGE tool empowers families to increase engagement in patient care. It was tested in a pilot trial, and 69% of participants used it, with ...

5.

researchgate.net

researchgate.net/publication/389768190_A_digital_tool_to_improve_family_engagement_in_acute_care_The_NGAGE_randomized_pilot_feasibility_trial

A Digital Tool to Improve Family Engagement in Acute Care

The results will inform the design of a multicentre effectiveness trial of use of the NGAGE tool. Clinical Trial Registration NCT05528185.

6.

healthaffairs.org

healthaffairs.org/doi/10.1377/hlthaff.2012.1133

Patient And Family Engagement: A Framework For ...

Patient and family engagement offers a promising pathway toward better-quality health care, more-efficient care, and improved population health.

7.

researchgate.net

researchgate.net/publication/366042343_Validation_of_an_Instrument_to_Measure_Family_Engagement_in_Acute_Cardiac_Care

Validation of an Instrument to Measure Family Engagement ...

Follow-up data were available for 76% of participants (67 of 88). Family members who used the NGAGE tool improved their family engagement score.

8.

withpower.com

withpower.com/trial/ngage-tool-for-family-engagement-036fd

NGAGE Tool for Family Engagement (NGAGE Trial)

What is the purpose of this trial? The primary aim of this trial is to evaluate if the NGAGE tool improves care engagement in family members of ICU patients.