Family Integration in Therapy for Critical Illness

(FIT-ICU Trial)

Recruiting at 2 trial locations

Overseen By Jose M Estrada

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Joseph's Healthcare Hamilton

Disqualifiers: End of life care, High risk injuries, Raised ICP, Bed-bound, others

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

Compensation: Varies

Number of Visits: 1

Duration: During ICU stay, up to 1 month

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on family involvement in physiotherapy for ICU patients.

What data supports the effectiveness of the treatment Family Integration in Therapy for Critical Illness?

Research suggests that involving family members in patient care in the ICU can improve patient outcomes, reduce complications, and shorten hospital stays. Family participation is also linked to better patient safety and quality of care. ^{1 2 3 4 5}

Is family integration in therapy for critical illness safe for humans?

Research suggests that involving families in patient care can improve patient safety and reduce complications, indicating it is generally safe. ^{4 6 7 8 9}

How is the Family Integration in Therapy Activities treatment different from other treatments for critical illness?

Family Integration in Therapy Activities is unique because it actively involves family members in the care of critically ill patients, which can improve patient outcomes and the overall experience for both patients and their families. This approach is different from traditional treatments that focus solely on medical interventions without family participation. ^{1 2 7 10 11}

What is the purpose of this trial?

An ICU admission is stressful for not only patients but their families as well. Research has shown that involving family members during a loved one's ICU stay can be helpful for them, but there is not clear direction on the best way to do this. For patients, family presence as well as early movement during their ICU stay has been shown to help recovery from things like delirium (a state of confusion) faster, and might prevent the weakness that can happen with a stay in the ICU. In this study, the investigators will explore whether having family help with moving patients through physiotherapy guided exercise can help both patients and families have a better experience and result from their ICU stay. The investigators hypothesize that family involvement in activities as part of an overall physiotherapy treatment plan will provide a tangible means for family members to engage in the care of their critically ill loved one, thus improving outcomes for both critically ill patients and family members.

Research Team

Kimberley Lewis, MD

Principal Investigator

The Research Institute of St Joe's Hamilton

Laiya Carayannopoulos, MD

Principal Investigator

The Research Institute of St Joe's Hamilton

Eligibility Criteria

This trial is for adults over 18 in the ICU, expected to stay at least 48 hours and have been recommended for physiotherapy. Family members who can be present during therapy sessions are also included. It's not for patients receiving end-of-life care, with certain high-risk injuries or conditions like severe brain injury, or those bed-bound before ICU admission.

Inclusion Criteria

A physiotherapist has approved me for physical therapy.

I am an adult (18 or older) currently in the ICU.

I am expected to stay in the hospital for at least 2 days and my doctor has requested physiotherapy for me.

Exclusion Criteria

I am at risk of high brain pressure due to a severe brain condition or surgery.

I am bed-bound or need a mechanical lift and not eligible for physiotherapy.

My family and I can fully participate without major physical, cognitive, or emotional barriers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Family members assist with physiotherapy guided exercises for patients in the ICU

During ICU stay, up to 1 month

Continuous involvement during ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including family satisfaction and PTSD symptoms

3 months

Assessments at 1 and 3 months

Treatment Details

Interventions

• Family Integration in Therapy Activities

Trial Overview The study tests if involving family in physiotherapy activities helps improve outcomes for both ICU patients and their families. The idea is that family participation might speed up recovery from delirium and prevent weakness associated with long ICU stays.

Participant Groups

Group I: All participants Experimental Treatment 1 Intervention

Patients to receive mobility interventions from trained family members

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Findings from Research

A study involving 374 critical care nurses revealed that effective involvement of family caregivers in patient care requires careful assessment of various factors, including the needs of nurses, patients, and caregivers.

Barriers such as patient care demands and limited resources hinder family caregiver involvement in intensive care units, highlighting the need for future research to address these challenges and improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative study of factors that influence active family involvement with patient care in the ICU: Survey of critical care nurses. Hetland, B., McAndrew, N., Perazzo, J., et al.[2019]

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]

Patient- and family-centered care interventions in the ICU led to a significant reduction in the length of stay by an average of 1.21 days, based on a meta-analysis of high-quality randomized studies involving 46 total studies.

While these interventions did not significantly affect mortality rates, they were associated with improvements in various important outcomes such as family satisfaction, patient experience, and mental health, indicating their potential benefits in the ICU setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Patient- and Family-Centered Care Interventions in the ICU: A Systematic Review and Meta-Analysis. Goldfarb, MJ., Bibas, L., Bartlett, V., et al.[2022]

A new questionnaire, the Family Involvement in Care Questionnaire, was developed to measure family involvement in inpatient care, showing strong content validity with an average score of 0.90 based on expert ratings.

Cognitive interviews with family members highlighted key issues such as the need for clearer definitions of family involvement and better response options, leading to a refined 16-item questionnaire that can help evaluate family engagement in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Family Involvement in Care Questionnaire-An instrument measuring family involvement in inpatient care. Drakenberg, A., Prignitz Sluys, K., Ericsson, E., et al.[2023]

Families of patients in the ICU feel that their participation is crucial for supporting their loved one's recovery, contributing significantly to the patient's emotional and psychosocial well-being.

The study identified key motivators and roles that families play during recovery, highlighting the need for healthcare practices to better support family involvement in patient care to enhance outcomes for both patients and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Families' perspectives of participation in patient care in an adult intensive care unit: A qualitative study. Wong, P., Redley, B., Digby, R., et al.[2021]

A survey of 158 adult ICUs in four Nordic countries revealed that while family involvement in decision-making is common, participation in daily care and critical situations like resuscitation varies significantly, indicating room for improvement.

Most ICUs reported having open or flexible visiting policies, but many still impose restrictions, and there is a lack of consistent communication with children and young relatives, highlighting the need for better practices in family care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family involvement in the intensive care unit in four Nordic countries. Frivold, G., Ågård, AS., Jensen, HI., et al.[2022]

A multicenter qualitative study involving 22 participants (4 patients, 5 family members, and 13 ICU staff) revealed strong support for family involvement in physiotherapy tasks for critically ill patients, highlighting the potential benefits for both physical recovery and psychological wellbeing.

Key themes identified included the need for clear communication, eligibility criteria for family participation, and the importance of addressing barriers such as safety and privacy, which are crucial for designing effective interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions and ideas of critically ill patients, their family and staff members regarding family participation in the physiotherapy-related care of critically ill patients: a qualitative study. van Delft, L., Valkenet, K., Slooter, A., et al.[2022]

A national survey of 41 intensive care units in Denmark revealed that 78% of responding nurses actively involved patients and families in daily care, highlighting the importance of engagement in improving care quality and safety.

While most units had strategies for patient and family engagement, only 4 out of 41 had established dedicated engagement panels, indicating a need for more structured approaches to enhance participation in care and research processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and family engagement in Danish intensive care units: A national survey. Oxenbøll Collet, M., Albertsen, H., Egerod, I.[2023]

Involving family members in the fundamental care of critical care patients, with support from nurses, significantly improved their perceptions of respect, collaboration, and support, as shown by a family-centered care survey conducted with 174 family members.

The intervention led to a notable increase in family-centered care scores from 3.2 to 3.5 at follow-up, with the family-centered care approach being the strongest predictor of improved scores, highlighting its effectiveness in enhancing family involvement in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive effects of a nursing intervention on family-centered care in adult critical care. Mitchell, M., Chaboyer, W., Burmeister, E., et al.[2022]

Involving families in critical care settings significantly helps meet the needs of both patients and their families during medical crises, highlighting the importance of family support in healthcare.

The article emphasizes the application of family systems theory and cultural considerations to create nursing care plans that effectively integrate family involvement in the care of critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Involving family systems in critical care nursing: challenges and opportunities. Leon, AM., Knapp, S.[2008]

A large majority (88.2%) of ICU caregivers believe that family participation in patient care should be encouraged, indicating a strong support for involving families in the ICU setting.

However, only 33.4% of family members expressed a desire to participate in care, with factors such as the patient's condition and the family's previous ICU experience influencing their willingness to engage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family participation in care to the critically ill: opinions of families and staff. Azoulay, E., Pochard, F., Chevret, S., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A qualitative study of factors that influence active family involvement with patient care in the ICU: Survey of critical care nurses. [2019]

2. 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]

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

Outcomes of Patient- and Family-Centered Care Interventions in the ICU: A Systematic Review and Meta-Analysis. [2022]

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

The Family Involvement in Care Questionnaire-An instrument measuring family involvement in inpatient care. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

Families' perspectives of participation in patient care in an adult intensive care unit: A qualitative study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Family involvement in the intensive care unit in four Nordic countries. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Perceptions and ideas of critically ill patients, their family and staff members regarding family participation in the physiotherapy-related care of critically ill patients: a qualitative study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Patient and family engagement in Danish intensive care units: A national survey. [2023]

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

Positive effects of a nursing intervention on family-centered care in adult critical care. [2022]

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

Involving family systems in critical care nursing: challenges and opportunities. [2008]

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

Family participation in care to the critically ill: opinions of families and staff. [2022]