NGAGE Tool for Family Engagement

(NGAGE Trial)

Recruiting at 1 trial location

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

Trial Summary

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 data supports the effectiveness of the NGAGE tool treatment for family engagement?

The research suggests that engaging families in healthcare, like with the NGAGE tool, can improve communication and care outcomes, as seen in studies involving cancer care and hospital planning. These studies highlight the benefits of involving family in healthcare decisions and communication, which aligns with the goals of the NGAGE tool. ^{1 2 3 4 5}

How does the NGAGE tool treatment differ from other treatments for family engagement?

The NGAGE tool is unique because it focuses on enhancing family engagement by using social networking capabilities to collect family health history, which is often under-utilized in clinical settings. This approach is novel compared to traditional methods, as it leverages online platforms to improve the collection and use of family health information. ^{6 7 8 9 10}

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. The secondary objectives are to assess if the NGAGE tool improves communication, care satisfaction, psychological symptoms, and quality of life in family members of ICU patients. The NGAGE trial is a stepped wedge cluster randomized trial of 6 Canadian adult ICUs, involving 194 family members. A family member will be considered anyone with a biological, emotional, or legal relationship with the patient and whom the patient wishes to be involved in their care. There will be random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The intervention group will have access to the NGAGE tool, which has modules to Learn, Engage, and Report. "Engage" allows the family member to indicate their desired engagement activity, which is then transmitted to the treating healthcare team to provide the requested activity. "Learn" contains educational capsules about the ICU environment and information about care participation. "Report" allows the family member to provide real-time feedback to the healthcare team. The primary endpoint is the FAMily Engagement (FAME) score within 1 week of ICU discharge. Secondary endpoints are family-centered outcomes, including communication quality, satisfaction, and mental health (anxiety and depression) scores within 1 week of ICU discharge, and quality of life and mental health (anxiety, depression, and post-traumatic distress symptoms) at 6 months. The mean difference of the validated FAME score, a continuous variable, will be compared between groups.

Research Team

Michael J Goldfarb, MD, MSc

Principal Investigator

Lady Davis Institute, McGill University, Jewish General Hospital

Eligibility Criteria

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 an adult family member of someone in the ICU.

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

I can communicate in English or French.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Sharing in care: engaging care partners in the care and communication of breast cancer patients. [2023]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Creating Change in Health Care: Developing a Shared Understanding and Roadmap for Action. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Patient engagement in the inpatient setting: a systematic review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Provider Experiences With Offering Families Bedside Health Record Access Across a Children's Hospital. [2021]

6. Brazil pubmed.ncbi.nlm.nih.gov

Semantic validation of educational technology with caregivers of children and adolescents undergoing chemotherapy. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Adapting Clinical Systems to Enable Adolescents' Genomic Choices. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Collecting Family Health History using an Online Social Network: a Nationwide Survey among Potential Users. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Caring Connection: developing an Internet resource for family caregivers of children with cancer. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Variation in use of Internet-based patient portals by parents of children with chronic disease. [2022]