Critical Care, Intensive Care, Family-centered Care, Family Engagement, Health Care Delivery, Patient and Family Engagement
Conditions
Keywords
Patient- and Family-Centered Care, Family Engagement, Critical Care, Intensive Care Unit, Person-Centered Care, Delivery of Health Care
Brief 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. 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.
Interventions
OTHERNGAGE tool
Access to NGAGE tool
Sponsors
Canadian Institutes of Health Research (CIHR)
Lady Davis Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult family members (age ≥ 18 years) of ICU patients * Expected ICU stay ≥ 48 hours * Able to participate in English or French
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FAMily Engagement (FAME) score within 1 week of ICU discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family satisfaction in the ICU (FS-ICU) | 1-week post-hospital discharge | 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. |
| Quality of communication (QOC score) | 1-week post-hospital discharge | 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. |
| Anxiety and depression (HADS) | 1-week post-hospital discharge | 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. |
| Post-traumatic stress (IES-Revised) | 6 months post-hospital discharge | 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. |
| Quality of life (EuroQOL-5D-5L score) | 6 months post-hospital discharge | 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 |
Countries
Canada
Contacts
Primary ContactJillian Kifell, MSc
Outcome results
None listed