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NCT Number: NCT05659485

Measuring Family Engagement in Care (The FAME Study)

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.

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Key information

Conditions

Family Engagement Critical Care Patient-centered Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Family engagement in care (as measured by FAME)

    Time frame: 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 outcomes

  1. Family activation (as measured by FAM-Activate)

    Time frame: 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.

  2. Family mental health (as measured by HADS)

    Time frame: 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.

  3. Family care satisfaction (as measured by FS-ICU 24)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jillian Kifell, MSc

CONTACT

[email protected]

5143408222 ext. 25806

Sponsors and collaborators

Lead sponsor

Lady Davis Institute

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Jewish General Hospital

Registry information

Acronym: FAME

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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