Family Participation for Intensive Care Engagement

(Family-ICU Trial)

Recruiting at 1 trial location

Overseen By Jillian Kifell, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lady Davis Institute

Disqualifiers: Repeat admissions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

194 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether family members joining medical team meetings in the ICU can improve their involvement in their loved one's care. Researchers aim to determine if this participation also enhances family satisfaction and reduces anxiety and depression. The trial consists of two phases: one where family members engage as usual and another where they join ICU team rounds. It is open to adults with a loved one in the ICU for at least 48 hours, who can attend meetings in person or online. As an unphased study, this trial offers a unique opportunity for families to actively participate in their loved one's care and potentially enhance their overall experience.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that family participation in ICU rounds is safe?

Research has shown that having family members present during ICU rounds is generally safe for everyone. A small initial study found that most ICU doctors and nurses welcomed the possibility of family joining rounds virtually. Including families in these meetings does not cause safety issues. Another study found that when families were present, they felt more satisfied and had better relationships with healthcare providers. No reports indicated any negative effects or problems from family participation. Overall, these findings suggest that allowing families to join ICU rounds is well-accepted and could enhance the care experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of involving family members in the ICU rounds, a practice not routinely implemented in many hospitals. Unlike standard care where family engagement is limited, this approach allows family members to actively participate in the decision-making process during team rounds. The unique aspect of this method is its potential to enhance communication, provide emotional support, and improve overall patient outcomes by fostering a more inclusive care environment. By studying this involvement, researchers hope to find out if it can lead to better satisfaction for both patients and families and potentially improve recovery rates.

What evidence suggests that family participation in ICU rounds improves family engagement in care?

This trial will compare family participation in ICU rounds with standard care practices. Studies have shown that family involvement in ICU rounds can be very beneficial. Research indicates that when families participate, they feel more satisfied with the care provided. For example, one study found higher satisfaction scores for families who participated compared to those who did not (87.3 vs 74.7). Another study showed that even virtual participation in ICU rounds led to better family involvement and higher satisfaction. Additionally, involving family members has been linked to better mental health and improved perceptions of patient care quality. Overall, evidence suggests that including family members in ICU rounds can positively impact both families and the healthcare process. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael J Goldfarb, MD, MSc

Principal Investigator

Lady Davis Institute, McGill University, Jewish General Hospital

Are You a Good Fit for This Trial?

This trial is for adult family members of ICU patients expected to stay in the ICU for at least 48 hours. Participants must be over 18 and able to join medical rounds virtually, meaning they need a phone or computer with internet and audio/video capabilities.

Inclusion Criteria

I am expected to stay in the ICU for at least 48 hours.

I am an adult family member of someone in the ICU.

I can join virtual meetings with a phone or computer that has internet and A/V.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Phase

Participants engage in care as per current family engagement practices without participating in daily ICU rounds.

Varies by site

Intervention Phase

Participants in the intervention group are invited to participate in attending team rounds.

Varies by site

Follow-up

Participants are monitored for family engagement, satisfaction, and psychological outcomes post-hospital discharge.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Participation in attending team rounds

Trial Overview The study tests if having families take part in ICU rounds improves their engagement in care. It also looks at family satisfaction, anxiety, depression, user experiences, and ways to better recruit and keep family participants. The trial uses a stepped-wedge design across six Canadian ICUs.

How Is the Trial Designed?

Group I: Phase 2 (Intervention) Experimental Treatment 1 Intervention

Participants in the Intervention group will be invited to participate in attending team rounds.

Group II: Phase 1 (Control group) Active Control 1 Intervention

Participants will be able to engage in care as per current family engagement practices. Family members in the usual care group will not participate in daily ICU rounds. In-person or virtual family participation in rounds is not routinely performed at any of the trial sites.

Participation in attending team rounds is already approved in Canada for the following indications:

Approved in Canada as Family Participation in ICU Rounds for:

• Improving family engagement in care
• Enhancing family satisfaction
• Reducing anxiety and depression

Who Is Running the Clinical Trial?

Lady Davis Institute

Lead Sponsor

Trials

50

Recruited

6,600+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Involving family members in daily rounds in adult intensive care units has shown limited improvement in family and staff satisfaction, based on a review of 15 studies, indicating that while there is some positive feedback, the overall impact may not be substantial.

Most studies reported improved family satisfaction as a key outcome, but the quality of the studies was generally poor to moderate, suggesting a need for more rigorous research to better understand the long-term effects and implementation challenges of family-centered care in critical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family ward rounds in intensive care: An integrative review of the literature. Kydonaki, K., Takashima, M., Mitchell, M.[2022]

Family presence during ICU rounds can enhance family satisfaction and improve relationships between families and healthcare providers, as reported in a review of 16 studies.

However, challenges such as concerns about patient confidentiality, increased rounding time, and potential impacts on teaching and academic discussions need to be addressed for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Presence on Rounds in Adult Critical Care: A Scoping Review. Calderone, A., Debay, V., Goldfarb, MJ.[2022]

A survey of 63 family members and 258 healthcare providers in ICUs revealed that while 97% of family members wanted to participate in rounds, only 38% of providers believed there was significant interest from families.

Providers were more likely than family members to view participation in rounds as potentially stressful and confusing for families, highlighting a gap in perceptions that could affect communication and decision-making in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family participation in intensive care unit rounds: Comparing family and provider perspectives. Au, SS., Roze des Ordons, A., Soo, A., et al.[2018]

Family participation in ICU bedside rounds can enhance communication and transparency between families and healthcare providers, benefiting both parties by improving knowledge and emotional support.

Identified barriers to effective family participation include logistical challenges, while facilitators such as proper preparation and organizational culture can help improve the integration of families into rounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family participation in ICU rounds-Working toward improvement. Roze des Ordons, AL., Au, S., Blades, K., et al.[2022]

Family participation in the care of older adult patients in the ICU can enhance physical, emotional, and psychological outcomes for both patients and their families, potentially easing the burden on the healthcare system.

Despite the benefits, barriers to family involvement exist, including factors related to the patient, ICU staff, family dynamics, and the ICU environment, highlighting the need for further research to explore effective interventions for improving family participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family participation in the care of older adult patients admitted to the intensive care unit: A scoping review. Heydari, A., Sharifi, M., Moghaddam, AB.[2021]

Families want to be more involved in the care of their loved ones in intensive care units, indicating a demand for greater family participation in this setting.

Nurses play a crucial role in facilitating family involvement in intensive care, highlighting the need for training and support to implement this innovative approach effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Families' participation in intensive care]. Simonet, N., Baudry, S.[2019]

A toolkit was developed to enhance family participation in ICU bedside rounds, based on ethnographic observations and collaborative input from family members and healthcare providers across various ICUs in Western Canada.

The toolkit emphasizes six key elements—Invitation, Orientation, Engagement, Summary, Questions, and Communication Follow-Up—to improve communication and ensure families can play a meaningful role in the care process, promoting patient-and-family-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best practices toolkit for family participation in ICU rounds. Au, SS., Roze des Ordons, AL., Blades, KG., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9646504/

Family Presence on Rounds in Adult Critical Care The main objective of this study was to explore the impact of family presence on adult ICU rounds on family and healthcare providers. DATA ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0883944125002321

Virtual family participation in adult intensive care unit rounds Virtual participation by family members in ICU rounds was feasible and was associated with improved family engagement scores and high satisfaction scores. These ...

3. cjcopen.ca cjcopen.ca/article/S2589-790X(23)00116-6/fulltext

Family Participation in Cardiovascular Intensive Care Unit ... Family members who participated in rounds had a higher level of satisfaction with care, compared to the usual-care group (87.3 vs 74.7, P = 0.03 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0964339725001491

Review Article Family participations in ICU medical rounds The results suggest that, family participation in ICU rounds has a positive impact on family mental health and improves perceptions of the quality of patient ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.123.010084

Family Engagement in the Adult Cardiac Intensive Care Unit The most common family engagement practices were open visitation (95%), information and support to families (85%), structured care conferences (n=82%), and ...

6. researchgate.net researchgate.net/publication/365188892_Family_Presence_on_Rounds_in_Adult_Critical_Care_A_Scoping_Review

(PDF) Family Presence on Rounds in Adult Critical Care Family presence on rounds was associated with increased family satisfaction with care, physician comfort, and improved physician-family relationship.

7. aacnjournals.org aacnjournals.org/ccnonline/article/39/5/14/22015/The-Power-of-Family-Engagement-in-Rounds-An

The Power of Family Engagement in Rounds: An Exemplar ... Family engagement in rounds has been recommended to improve communication, but its impact on patient outcomes is unknown.