Measuring Family Engagement in Care (The FAME Study) (FAME)

February 11, 2025 updated by: Michael Goldfarb, Lady Davis Institute
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Active, not recruiting
        • Foothills Medical Centre
    • Ontario
      • Toronto, Ontario, Canada
        • Suspended
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • Montreal General Hospital
      • Montreal, Quebec, Canada
      • Montreal, Quebec, Canada
        • Active, not recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Montréal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital / Lady Davis Institute
        • Contact:
        • Contact:
          • Michael J Goldfarb, MD MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 24 hours of enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 24 hours of enrolment
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.
Within 2 weeks of hospital discharge.
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.
Within 2 weeks of hospital discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lady Davis Institute

Collaborators

Canadian Institutes of Health Research (CIHR)
Jewish General Hospital

Investigators

  • Principal Investigator: Michael J Goldfarb, MD MSc, Lady Davis Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

December 12, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-3191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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