Recruiting

Observational Study

Sponsor:

Lady Davis Institute

Code:

NCT05659485

Conditions

Family Engagement

Patient-centered Care

Critical Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Family Engagement

Patient-centered Care

Critical Care

Study ID

NCT05659485

Start date

Jan 31, 2023

Status verified date

Feb, 2025

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

198 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Family engagement in care (as measured by FAME) [ Time Frame: Within 24 hours of enrolment ]

Central Contacts and Locations

Central contacts

Jillian Kifell, MSc

5143408222jillian.kifell.ccomtl@ssss.gouv.qc.ca

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada

Contacts

Jillian Kifell, MSc

5143408222jillian.kifell.ccomtl@ssss.gouv.qc.ca

Jewish General Hospital / Lady Davis Institute

Recruiting

Montréal, Quebec, Canada, H3T 1E2

Contacts

Jillian Kifell, MSc

514-340-8222jillian.kifell.ccomtl@ssss.gouv.qc.ca

Principal Investigator:

Michael J Goldfarb, MD MSc

More Information

Sponsor

Lady Davis Institute

Last update posted

Feb 13, 2025

Last verified

Feb, 2025

Keywords

  • Family
  • Engagement
  • Family engagement
  • Family-centered care
  • Measures
  • Instruments
  • Intensive care unit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lady Davis Institute on 2025-02-13.