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

Trial Summary

What is the purpose of this trial?

Family inclusion in adult intensive care unit (ICU) rounds is recommended by critical care professional societies, yet widespread uptake of this practice is limited. A key barrier cited by ICU clinicians is insufficient evidence to support this practice. There is a need for robust evidence to support family participation in adult ICU rounds and influence change to routine clinical care. The primary purpose of this study is to assess whether family participation in adult ICU rounds improves family engagement in care. The secondary objectives are to assess family satisfaction, and anxiety and depression, to explore user experiences of family participation in ICU rounds, and to evaluate strategies to improve family member recruitment and retention rates. This is a stepped-wedge cluster randomized trial (n=194) at 6 Canadian ICUs. The stepped wedge cluster randomized trial is a pragmatic study design that overcomes methodological limitations in evaluating a healthcare service delivery intervention. In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The stepped-wedge design also allows each site to function as its own control. The stepped-wedge design is more powerful than a parallel design when substantial cluster level effects are present.

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 data supports the effectiveness of the treatment Family Participation in ICU Rounds?

Research suggests that involving family members in ICU rounds can improve communication between families and healthcare providers, which is believed to enhance patient care and outcomes. ^{1 2 3 4 5}

Is family participation in ICU rounds safe for humans?

The research does not provide specific safety data, but family participation in ICU rounds is generally recommended by healthcare professionals, suggesting it is considered safe. ^{1 2 3 4 6}

How is family participation in ICU rounds different from other treatments for ICU care?

Family participation in ICU rounds is unique because it involves family members directly in the medical discussions and decision-making process during bedside rounds, which can improve communication and potentially enhance patient outcomes. Unlike traditional treatments that focus solely on medical interventions, this approach emphasizes family involvement as a key component of care. ^{1 2 4 5 7}

Research Team

Michael J Goldfarb, MD, MSc

Principal Investigator

Lady Davis Institute, McGill University, Jewish General Hospital

Eligibility Criteria

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 an adult family member of someone in the ICU.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Family ward rounds in intensive care: An integrative review of the literature. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Family participation in ICU rounds-Working toward improvement. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Family participation in intensive care unit rounds: Comparing family and provider perspectives. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Best practices toolkit for family participation in ICU rounds. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Family participation in the care of older adult patients admitted to the intensive care unit: A scoping review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Family Presence on Rounds in Adult Critical Care: A Scoping Review. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Families' participation in intensive care]. [2019]