Measuring Family Engagement in Care (The FAME Study)

Recruiting

• Conditions: Critical Care; Family Engagement; Patient-centered Care

• Registration Number: NCT05659485
• Lead Sponsor: Lady Davis Institute

Brief Summary

There are currently no validated tools to specifically measure family engagement in the intensive care unit (ICU). To address this gap, an interdisciplinary team developed a novel instrument to measure family engagement in the ICU. This will be a prospective observational cohort with an embedded qualitative study to validate the FAMily Engagement (FAME) instrument in the ICU setting. This study will also evaluate the association between family activation, engagement, and family-centred outcomes, and exploring factors (age, relationship, sex, gender, race/ethnicity) that may influence family engagement in the ICU.

Detailed Description

This will be a prospective observational cohort study of 198 family members in the ICUs of 4 Canadian hospitals in 3 provinces (Alberta, Ontario, and Quebec) over a 12-week period. These sites were chosen due to their urban setting and distant geographic range to capture differing practice patterns, a higher percentage of racialized patients, and language and cultural differences. The target recruitment is 50 family members from each participating site. A "family member" will be considered anyone with a biological, legal, or emotional relationship with the patient and whom the patient would want involved in their care.

Study Timeline

• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-21
• Study Start: 2023-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-12
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• Family member of patient admitted to the intensive care units
• Able to participate in English or French
• Age 18 years old or older

Exclusion Criteria

• ICU stays less than 24 hours
• Another family member has already participated in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Family engagement in care (as measured by FAME)	Within 24 hours of enrolment	The FAMily Engagement (FAME) questionnaire is an instrument developed to assess current family engagement practice. Items address key principles of family-centered care, such as dignity and respect, information sharing, participation, and collaboration. They also address family engagement domains, including family presence, family needs, communication and education, decision making, and direct care. A five-point Likert scale (1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree) is used for responses, which are then transformed to a 0-100 scoring system, with higher scores indicating greater engagement in care and lower scores indicating lesser engagement in care. The overall engagement score is calculated by dividing the sum of the scores by the number of questions answered, with the result ranging from 0-100.

Secondary Outcome Measures

Name	Time	Method
Family care satisfaction (as measured by FS-ICU 24)	Within 2 weeks of hospital discharge.	The Family Satisfaction in the ICU survey (FS-ICU 24) is a validated 24-item self-report instrument that assesses family satisfaction and experience with care in the ICU.
Family activation (as measured by FAM-Activate)	Within 24 hours of enrolment	FAM-Activate is a 4-question measure that assesses the family member's knowledge, skills, and confidence concerning care participation.
Family mental health (as measured by HADS)	Within 2 weeks of hospital discharge.	The Hospital Anxiety and Depression Scale (HADS) survey is a validated self-reported instrument to measure anxiety and depression in medical patients. The survey consists of 14 questions (7 depression-related and 7 anxiety-related) which are scored on a 4-point Likert scale (0-3). The sum of the sub-scores on each of the two subscales (anxiety and depression) represents the total score. A lower total score indicates a milder condition whereas a higher total score indicates a higher level of distress.

Trial Locations

Locations (6)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montreal, Quebec, Canada

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada

Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada

Jewish General Hospital / Lady Davis Institute; 🇨🇦 Montréal, Quebec, Canada