Family EngagementNGAGENCT06586528
Increasing Family Engagement in Critical Care
A study testing NGAGE tool in people with Family Engagement and Critical Care, Intensive Care, run by Lady Davis Institute at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family Engagement, Critical Care, Intensive Care, Patient and Family Engagement
- What is being tested?
- NGAGE tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 2 sitesCanada
- Study dates
- 26 Mar 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult family members (age ≥ 18 years) of ICU patients
- Expected ICU stay ≥ 48 hours
- Able to participate in English or French
Who cannot join
- Family members who do not wish to participate in care
- Repeat admissions within the study period
- Another family member has already participated in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec
Jillian Kifell, MSc, 514-340-8222 ext. 25806, jillian.kifell.ccomtl@ssss.gouv.qc.ca
Michael J Goldfarb, MD, MSc
- Recruiting
McGill University Health Centre
Montreal, Quebec
Jillian Kifell, MSc, 5143408222 ext. 25806, jillian.kifell.ccomtl@ssss.gouv.qc.ca
Michael J Goldfarb, MD, MSc
About this study
Official title: Increasing Family Engagement in Critical Care: The NGAGE Trial (The NGAGE 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.
- Conditions
- Family Engagement, Critical Care, Intensive Care, Patient and Family Engagement, Health Care Delivery, Family-centered Care
- Being tested
- NGAGE tool
- Keywords
- Patient- and Family-Centered Care, Family Engagement, Critical Care, Intensive Care Unit, Person-Centered Care, Delivery of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGAGE toolOther
Access to NGAGE tool
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Usual Care | No 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. |
| Intervention Group: Access to NGAGE Tool | Experimental | Participants in the intervention group will be provided access to the NGAGE tool. Receives: Other: NGAGE tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAMily Engagement (FAME) score within 1 week of ICU discharge
The FAMily Engagement (FAME) tool is a self-administered 12-item questionnaire that assesses an individual's current engagement practice. FAME uses a five-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree), and scale results are changed to a 0-100 scoring system, with higher scores indicating greater engagement in care. The following subdomains are evaluated: engagement perception, family presence, communication, education, decision-making, care contribution, and family needs. FAME includes the following engagement domains: family presence, family needs, communication and education, decision making, and direct care. FAME also captures the following family-centered care principles: dignity and respect, information sharing, participation, and collaboration.
Measured: 1-week post-hospital discharge
Secondary outcomes (6)
Family satisfaction in the ICU (FS-ICU)
The Family Satisfaction in the ICU survey (FS-ICU) is a 24-item instrument that was developed and validated to assess family satisfaction and experience with care in the ICU. Scores range from 0 to 100, with higher scores indicate greater satisfaction.
Measured: 1-week post-hospital discharge
Quality of communication (QOC score)
The Quality of Communication tool is a 13-item questionnaire that was developed and validated in an ICU setting to measure the perceived quality of communication. Scores range from 0 to 100, with higher scores indicating better clinician-family communication.
Measured: 1-week post-hospital discharge
Anxiety and depression (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a simple to use, validated, and widely used self-reported tool to measure anxiety and depression in medical patients. The survey is composed of 14 questions: 7 depression-related and 7 anxiety-related questions. The score for each item ranges from 0 to 3, and subscale scores greater than 8 denotes anxiety or depression.
Measured: 1-week post-hospital discharge
Anxiety and depression (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a simple to use, validated, and widely used self-reported tool to measure anxiety and depression in medical patients. The survey is composed of 14 questions: 7 depression-related and 7 anxiety-related questions. The score for each item ranges from 0 to 3, and subscale scores greater than 8 denotes anxiety or depression.
Measured: 6 months post-hospital discharge
Post-traumatic stress (IES-Revised)
The IES-Revised is a 22-item questionnaire that has been validated and is widely used for measuring post-traumatic stress symptoms and yields a total score ranging from 0 to 88 and subscale scores for the Intrusion, Avoidance, and Hyperarousal subscales. Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). High scores indicate greater severity of PTSD.
Measured: 6 months post-hospital discharge
Quality of life (EuroQOL-5D-5L score)
The EuroQOL-5D-5L is a 5-item questionnaire that has been validated and is widely used for measuring health-related quality of life. Each dimension has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The scores are combined to generate a single index value for overall health status. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state
Measured: 6 months post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start26 Mar 2025
- Primary completionJul 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family EngagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Michael Goldfarb, Lady Davis Institute
- Investigators
- Michael J Goldfarb, MD, MSc, Principal investigator, Lady Davis Institute, McGill University, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586528
- Sponsor's protocol ID
- 2025-4301
- Acronym
- NGAGE
- Status last verified
- May 2025
- First submitted
- 4 Sep 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Family Engagement in Critical Care: The NGAGE Trial (The NGAGE Trial)
- ClinicalTrials.gov ID
- NCT06586528
- Acronym / sponsor ID
- NGAGE / 2025-4301
- Conditions
- Family Engagement, Critical Care, Intensive Care, Patient and Family Engagement, Health Care Delivery, Family-centered Care
- Keywords
- Patient- and Family-Centered Care, Family Engagement, Critical Care, Intensive Care Unit, Person-Centered Care, Delivery of Health Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed
| Arm | Type | Receives |
|---|---|---|
| Control Group: Usual Care | No 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. |
| Intervention Group: Access to NGAGE Tool | Experimental | Other: NGAGE toolParticipants in the intervention group will be provided access to the NGAGE tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult family members (age ≥ 18 years) of ICU patients
- Expected ICU stay ≥ 48 hours
- Able to participate in English or French
Key exclusion criteria (3 listed)
- Family members who do not wish to participate in care
- Repeat admissions within the study period
- Another family member has already participated in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGAGE toolAccess to NGAGE tool | Other | Intervention Group: Access to NGAGE Tool |
Primary outcome
FAMily Engagement (FAME) score within 1 week of ICU discharge
Time frame: 1-week post-hospital discharge
The FAMily Engagement (FAME) tool is a self-administered 12-item questionnaire that assesses an individual's current engagement practice. FAME uses a five-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree), and scale results are changed to a 0-100 scoring system, with higher scores indicating greater engagement in care. The following subdomains are evaluated: engagement perception, family presence, communication, education, decision-making, care contribution, and family needs. FAME includes the following engagement domains: family presence, family needs, communication and education, decision making, and direct care. FAME also captures the following family-centered care principles: dignity and respect, information sharing, participation, and collaboration.
6 secondary outcomes
Family satisfaction in the ICU (FS-ICU)
Time frame: 1-week post-hospital discharge
Quality of communication (QOC score)
Time frame: 1-week post-hospital discharge
Anxiety and depression (HADS)
Time frame: 1-week post-hospital discharge
Anxiety and depression (HADS)
Time frame: 6 months post-hospital discharge
Post-traumatic stress (IES-Revised)
Time frame: 6 months post-hospital discharge
Quality of life (EuroQOL-5D-5L score)
Time frame: 6 months post-hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
Related trials for Family Engagement
Recruiting
Family Connections
Emotional Disturbance, Behavior Disorders in Children
Recruiting
Reach and Engagement of GENetic Education, Risk Assessment, and TEsting Feasibility Trial
Pancreatic Ductal Adenocarcinoma (PDAC), Family History of Pancreas Cancer
Active, not recruiting
The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now
Communication
RecruitingObservational study
Descriptions and Practices of Family Engagement in Emergency Care Setting
Emergency Care
Recruiting
Provider-Mediated Communication of Genetic Testing Results to At-Risk Relatives of Cancer Patients to Improve Genetic Counseling and Testing Rates, Family HOPE Study
Hematopoietic and Lymphoid System Neoplasm, Hereditary Malignant Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael J Goldfarb, MD, MSc principal investigator
Lady Davis Institute, McGill University, Jewish General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NGAGE tool in people with Family Engagement and Critical Care, Intensive Care, run by Lady Davis Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jillian Kifell, MSc (5143408222 ext. 25806, jillian.kifell.ccomtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FAMily Engagement (FAME) score within 1 week of ICU discharge (time frame: 1-week post-hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.