Measuring Family Engagement in Care (The FAME Study)

NCT05659485 | Recruiting

• 1 other identifier: 2022-3191
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 6

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Family engagement in care (as measured by FAME)

  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 Outcomes (3)

• Family activation (as measured by FAM-Activate)

  Within 24 hours of enrolment

• Family mental health (as measured by HADS)

  Within 2 weeks of hospital discharge.

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

  Within 2 weeks of hospital discharge.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Family member of patient admitted to the intensive care units
• Able to participate in English or French
• Age 18 years old or older

You may not qualify if:

• ICU stays less than 24 hours
• Another family member has already participated in the study

Sponsors & Collaborators

• Lady Davis Institute: lead
• Jewish General Hospital: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (6)

Foothills Medical Centre

Calgary, Alberta, Canada

ACTIVE NOT RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

SUSPENDED

Jewish General Hospital / Lady Davis Institute

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

ACTIVE NOT RECRUITING

Montreal General Hospital

Montreal, Quebec, Canada

RECRUITING

Royal Victoria Hospital

Montreal, Quebec, Canada

RECRUITING

Related Publications (9)

• 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.

  PMID: 31771546 BACKGROUND

• 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.

  PMID: 25635496 BACKGROUND

• 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.

  PMID: 18780129 BACKGROUND

• 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.

  PMID: 30113379 BACKGROUND

• 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.

  PMID: 32533931 BACKGROUND

• 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.

  PMID: 35446109 BACKGROUND

• 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.

  PMID: 28749855 BACKGROUND

• 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.

  PMID: 36444373 BACKGROUND

• 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. 2026 Mar;58(1):78-85. doi: 10.1177/08445621251385620. Epub 2025 Oct 15.

  PMID: 41091932 DERIVED

Study Officials

• Michael J Goldfarb, MD MSc

  Lady Davis Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jillian Kifell, MSc

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Staff, Division of Cardiology

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 21, 2022
• Study Start: January 31, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)