Family Integration in Therapy for Critical Illness

(FIT-ICU Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how family involvement in physiotherapy can improve recovery for ICU patients and enhance the experience for family members. The study examines whether family members assisting with patient movement and exercises can lead to better outcomes, such as faster recovery from confusion and prevention of muscle weakness. Those with a loved one in the ICU for at least two days and who can be present often are well-suited for participation. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance ICU recovery experiences for patients and their families.

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 prior data suggests that family integration in therapy activities is safe for ICU patients and their families?

Research shows that family involvement in caring for ICU patients can be safe and beneficial. Studies indicate that when families participate, patients experience reduced anxiety and feel more comfortable and secure. Additionally, family involvement is associated with improved mental health for relatives, including reduced anxiety and PTSD.

While specific data on negative effects from family involvement is lacking, overall evidence suggests it is well-accepted. Family members find value in helping with care, and this active role does not appear to cause harm. Thus, involving family in therapy activities in the ICU seems to be a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about family integration in therapy activities because it brings a fresh approach to managing critical illness. Unlike traditional care, which primarily involves healthcare professionals, this method empowers family members to actively participate in patient mobility interventions. This unique involvement could enhance emotional support and motivation for patients, potentially leading to improved recovery outcomes. Additionally, integrating family in therapy might reduce healthcare costs and improve the overall experience for both patients and their families.

What evidence suggests that family integration in therapy activities is effective for improving ICU outcomes?

Research has shown that involving family in the care of ICU patients can lead to better outcomes. A review of studies found that nearly two-thirds of research on family-centered care in adult ICUs demonstrated improved patient results. Another review indicated that care approaches focusing on both patients and their families can reduce confusion (known as delirium) among ICU patients. In this trial, all participants will receive mobility interventions from trained family members, suggesting that family assistance with patient movement and therapy activities could speed recovery and enhance the ICU experience. Family involvement may also benefit family members by providing a meaningful role in their loved one's care. ^{2 6 7 8 9}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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 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 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]

Citations

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A systematic review of randomized controlled trials The systematic review found that nearly two-thirds of randomized clinical trials of family-centered interventions in the adult ICU improved patient outcomes.

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Family Support Strategies During Intensive Care Unit In recent years, systematic reviews have shown that interventions for families of patients in ICUs focus on involvement outcomes, such as ...

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Nurse-Led Family Support Intervention for ... This cluster-randomized trial assesses whether a nurse-led, interprofessional family support intervention involving engagement, support, ...

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The impact of patient- and family-centered care ... This systematic review and meta-analysis suggests that PFCC interventions are effective in reducing the incidence of delirium among ICU patients. However, these ...

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Patient and family involvement in adult critical ... This scoping review investigates the extent and range of literature on patient and family involvement in critical and intensive care settings.

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Family involvement in the intensive care unit, moving to ... Family participation in essential care may be beneficial for both ICU patients and relatives [2]. It may also improve the patient's comfort, safety and quality ...

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Family participation in essential care activities in adult ... Family participation in the intensive care unit is associated with a reduction of mental health symptoms of anxiety and PTSD. Use of additional ...

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Defining Patient and Family Engagement in the Intensive ... Patient and family engagement in the ICU is an active partnership between health professionals and patients and families working at every level of the ...