Measuring Family Engagement in Care (The FAME Study)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLady Davis Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Family member of patient admitted to the intensive care units
Able to participate in English or French
Age 18 years old or older
Disqualifiers
ICU stays less than 24 hours
Another family member has already participated in the study
Trial population
Family members, aged 18 years old or older, of patients admitted to intensive care units. The term "Family member" includes anyone that has a biological, legal, or emotional relationship with the patient and the patient would like to be involved in their care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Family engagement in care (as measured by FAME)
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.
Time frame
Within 24 hours of enrolmentSecondary outcomes
1
Family activation (as measured by FAM-Activate)
FAM-Activate is a 4-question measure that assesses the family member's knowledge, skills, and confidence concerning care participation.
Time frame
Within 24 hours of enrolment2
Family mental health (as measured by HADS)
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.
Time frame
Within 2 weeks of hospital discharge.3
Family care satisfaction (as measured by FS-ICU 24)
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.
Time frame
Within 2 weeks of hospital discharge.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lady Davis Institute
Lead sponsor
Jewish General Hospital
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov