Measuring Family Engagement in Care (The FAME Study)

Last updated: February 11, 2025
Sponsor: Lady Davis Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05659485
2022-3191
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • ICU stays less than 24 hours

  • Another family member has already participated in the study

Study Design

Total Participants: 198
Study Start date:
January 31, 2023
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Foothills Medical Centre

    Calgary, Alberta
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto, Ontario
    Canada

    Suspended

  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec
    Canada

    Site Not Available

  • Montreal General Hospital

    Montreal, Quebec
    Canada

    Active - Recruiting

  • Royal Victoria Hospital

    Montreal, Quebec
    Canada

    Active - Recruiting

  • Jewish General Hospital / Lady Davis Institute

    Montréal, Quebec H3T 1E2
    Canada

    Active - Recruiting

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