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Family EngagementFAMENCT05659485

Measuring Family Engagement in Care (The FAME Study)

An observational study of Family Engagement and Patient-centered Care, run by Lady Davis Institute at 6 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
198 participants
Where
6 sitesCanada
Study dates
31 Jan 2023to 30 Dec 2025
How long will I take part?
2 Weeks
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jillian Kifell, MSc contact

5143408222 ext. 25806

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

6 sites in 1 country

Canada6 sites, 3 recruiting

  • Foothills Medical Centre

    Calgary, Alberta

    Active, not recruiting

  • Jewish General Hospital / Lady Davis Institute

    Montreal, Quebec, H3T 1E2

    Jillian Kifell, MSc, 514-340-8222 ext. 25806, jillian.kifell.ccomtl@ssss.gouv.qc.ca

    Michael J Goldfarb, MD MSc

    Recruiting

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

    Montreal, Quebec

    Active, not recruiting

  • Montreal General Hospital

    Montreal, Quebec

    Recruiting

  • Royal Victoria Hospital

    Montreal, Quebec

    Jillian Kifell, MSc, 5143408222 ext. 25806, jillian.kifell.ccomtl@ssss.gouv.qc.ca

    Recruiting

  • St. Michael's Hospital

    Toronto, Ontario

    Suspended

Other trials in Canada

About this study

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.

Read the 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.

Keywords
Family, Engagement, Family engagement, Family-centered care, Measures, Instruments, Intensive care unit

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 24 hours of enrolment

Secondary outcomes (3)

  1. Family activation (as measured by FAM-Activate)

    FAM-Activate is a 4-question measure that assesses the family member's knowledge, skills, and confidence concerning care participation.

    Measured: Within 24 hours of enrolment

  2. Family mental health (as measured by HADS)

    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.

    Measured: Within 2 weeks of hospital discharge.

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

    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.

    Measured: Within 2 weeks of hospital discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start31 Jan 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
198 participants (estimated)
Target duration
2 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT05659485
Sponsor's protocol ID
2022-3191
Acronym
FAME
Status last verified
Feb 2025
First submitted
5 Dec 2022
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31771546

  • 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.

    PubMed 25635496

  • 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.

    PubMed 18780129

  • 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.

    PubMed 30113379

  • 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.

    PubMed 32533931

  • 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.

    PubMed 35446109

  • 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.

    PubMed 28749855

  • 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.

    PubMed 36444373

  • 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.

    PubMed 41091932

Questions about this trial

What is this clinical trial studying?

An observational study of Family Engagement and Patient-centered Care, run by Lady Davis Institute at 6 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jillian Kifell, MSc (5143408222 ext. 25806, jillian.kifell.ccomtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Family engagement in care (as measured by FAME) (time frame: Within 24 hours of enrolment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05659485, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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