Measuring Family Engagement in Care (The FAME Study)

Critical Care Clinical Trial

— FAME  

Official title:

Measuring Family Engagement in Care (The FAME Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05659485
• Other study ID #: 2022-3191
• Status: Recruiting
• Start date: January 31, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Lady Davis Institute
• Contact: Michael J Goldfarb, MD MSc
• Phone: 5143408222
• Email: michael.j.goldfarb[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: December 30, 2024
• Est. primary completion date: August 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care
• Family Engagement
• Patient-centered Care

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Jewish General Hospital / Lady Davis Institute	Montréal	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lady Davis Institute	Jewish General Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Crit Care Med. 2018 Mar;46(3):e278. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Within 24 hours of enrolment
Secondary	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.	Within 2 weeks of hospital discharge.
Secondary	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.	Within 2 weeks of hospital discharge.