Measuring Family Engagement in Care (The FAME Study)

NCT ID: NCT05659485

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 198 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2025-12-30

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.

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.

Conditions

Family Engagement; Patient-centered Care; Critical Care

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jewish General Hospital

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Lady Davis Institute

OTHER

Sponsor Role: lead

Responsible Party

Michael Goldfarb

Attending Staff, Division of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael J Goldfarb, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Lady Davis Institute

Locations

Foothills Medical Centre

Calgary, Alberta, Canada

Site Status: ACTIVE_NOT_RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status: SUSPENDED

Jewish General Hospital / Lady Davis Institute

Montreal, Quebec, Canada

Site Status: RECRUITING

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Site Status: ACTIVE_NOT_RECRUITING

Montreal General Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jillian Kifell, MSc

Role: CONTACT

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

5143408222 ext. 25806

Facility Contacts

Jillian Kifell, MSc

Role: primary

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

514-340-8222 ext. 25806

Jillian Kifell, MSc

Role: primary

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

5143408222 ext. 25806

References

Barello S, Castiglioni C, Bonanomi A, Graffigna G. The Caregiving Health Engagement Scale (CHE-s): development and initial validation of a new questionnaire for measuring family caregiver engagement in healthcare. BMC Public Health. 2019 Nov 27;19(1):1562. doi: 10.1186/s12889-019-7743-8.

Reference Type: BACKGROUND

PMID: 31771546 (View on PubMed)

Brown SM, Rozenblum R, Aboumatar H, Fagan MB, Milic M, Lee BS, Turner K, Frosch DL. Defining patient and family engagement in the intensive care unit. Am J Respir Crit Care Med. 2015 Feb 1;191(3):358-60. doi: 10.1164/rccm.201410-1936LE. No abstract available.

Reference Type: BACKGROUND

PMID: 25635496 (View on PubMed)

Anderson WG, Arnold RM, Angus DC, Bryce CL. Posttraumatic stress and complicated grief in family members of patients in the intensive care unit. J Gen Intern Med. 2008 Nov;23(11):1871-6. doi: 10.1007/s11606-008-0770-2. Epub 2008 Sep 9.

Reference Type: BACKGROUND

PMID: 18780129 (View on PubMed)

Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

Reference Type: BACKGROUND

PMID: 30113379 (View on PubMed)

Goldfarb M, Bibas L, Burns K. Patient and Family Engagement in Care in the Cardiac Intensive Care Unit. Can J Cardiol. 2020 Jul;36(7):1032-1040. doi: 10.1016/j.cjca.2020.03.037. Epub 2020 Mar 31.

Reference Type: BACKGROUND

PMID: 32533931 (View on PubMed)

Goldfarb MJ, Bechtel C, Capers Q 4th, de Velasco A, Dodson JA, Jackson JL, Kitko L, Pina IL, Rayner-Hartley E, Wenger NK, Gulati M; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Lifelong Congenital Heart Disease and Heart Health in the Young; Council on Cardiovascular Radiology and Intervention; Council on Hypertension; Council on the Kidney in Cardiovascular Disease; and Council on Lifestyle and Cardiometabolic Health. Engaging Families in Adult Cardiovascular Care: A Scientific Statement From the American Heart Association. J Am Heart Assoc. 2022 May 17;11(10):e025859. doi: 10.1161/JAHA.122.025859. Epub 2022 Apr 21.

Reference Type: BACKGROUND

PMID: 35446109 (View on PubMed)

Goldfarb MJ, Bibas L, Bartlett V, Jones H, Khan N. Outcomes of Patient- and Family-Centered Care Interventions in the ICU: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 Oct;45(10):1751-1761. doi: 10.1097/CCM.0000000000002624.

Reference Type: BACKGROUND

PMID: 28749855 (View on PubMed)

Goldfarb M, Debigare S, Foster N, Soboleva N, Desrochers F, Craigie L, Burns KEA. Development of a Family Engagement Measure for the Intensive Care Unit. CJC Open. 2022 Aug 5;4(11):1006-1011. doi: 10.1016/j.cjco.2022.07.015. eCollection 2022 Nov.

Reference Type: BACKGROUND

PMID: 36444373 (View on PubMed)

Duong J, Kifell J, Gelinas C, Udupa S, Beydoun SA, Stephenson A, Goldfarb M. Validation of the French-Canadian Version of FAME, a Family Engagement Measurement Tool for the Intensive Care Unit. Can J Nurs Res. 2025 Oct 15:8445621251385620. doi: 10.1177/08445621251385620. Online ahead of print.

Reference Type: DERIVED

PMID: 41091932 (View on PubMed)

Other Identifiers

2022-3191

Identifier Type: -

Identifier Source: org_study_id