Family Participation in Intensive Care Unit Rounds (The Family-ICU Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Virtual Care
- Sponsor
- Lady Davis Institute
- Enrollment
- 194
- Locations
- 2
- Primary Endpoint
- FAMily Engagement (FAME) score within 1 week of ICU discharge
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
Family inclusion in adult intensive care unit (ICU) rounds is recommended by critical care professional societies, yet widespread uptake of this practice is limited. A key barrier cited by ICU clinicians is insufficient evidence to support this practice. There is a need for robust evidence to support family participation in adult ICU rounds and influence change to routine clinical care. The primary purpose of this study is to assess whether family participation in adult ICU rounds improves family engagement in care. The secondary objectives are to assess family satisfaction, and anxiety and depression, to explore user experiences of family participation in ICU rounds, and to evaluate strategies to improve family member recruitment and retention rates. This is a stepped-wedge cluster randomized trial (n=194) at 6 Canadian ICUs. The stepped wedge cluster randomized trial is a pragmatic study design that overcomes methodological limitations in evaluating a healthcare service delivery intervention. 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. The stepped-wedge design also allows each site to function as its own control. The stepped-wedge design is more powerful than a parallel design when substantial cluster level effects are present.
Investigators
Michael Goldfarb
Attending Staff, Division of Cardiology
Lady Davis Institute
Eligibility Criteria
Inclusion Criteria
- •Adult family members (age ≥ 18 years) of ICU patients
- •Expected ICU stay ≥ 48 hours
- •Family members wishing to participate in rounds virtually must have the technological capability and understanding to participate virtually (must have a phone or computer with internet and audio/video capabilities)
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
Outcomes
Primary Outcomes
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.
Quality of communication (QOC score)
Time Frame: 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.
Secondary Outcomes
- Anxiety and depression (HADS)(1-week post-hospital discharge)
- Post-traumatic stress (IES-Revised)(6 months post-hospital discharge)
- Family satisfaction in the ICU (FS-ICU)(1-week post-hospital discharge)
- Quality of life (EuroQOL-5D-5L score)(6 months post-hospital discharge)
- Anxiety and depression (HADS)(6 months post-hospital discharge)