Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study

Study Overview
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Brief Summary
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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.

Official Title
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Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study

Conditions
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Critical Illness, Delirium

Intervention / Treatment
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* Other: Family involvement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (≥18 years) in the ICU Anticipated length of stay ≥48 hours for whom a request for physiotherapy has been placed by the treating physician Appropriateness for physiotherapy confirmed by the unit's physiotherapist. Families will be eligible if they are able to be present in ICU during physiotherapist or research team work hours until they are cleared to deliver activities independently, then at least three times weekly thereafter. Exclusion Criteria: Patients who are receiving end of life care Patients who have high risk injuries including spinal cord injury or spinal fractures, post-operative from spinal surgery, and untreated hip or long bone fractures Patients at risk of raised intracranial pressure (ICP) (e.g. Malignant middle cerebral artery stroke, large subarachnoid hemorrhage), admitted post trauma activation, post-operative from brain surgery or with external ventricular drain (EVD) in situ. Patients who are bed-bound or require mechanical lift at baseline who would not otherwise be offered physiotherapy services. Exclusion criteria for families include any major barriers to participation, i.e., physical, cognitive, emotional or capacity to understand and communicate with the team.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All participants<br>Patients to receive mobility interventions from trained family members | Other: Family involvement<br>* Family delivery of mobility activities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - consent rate | We define a successful consent rate as > 70% of SDMs or patients approached to consent, agreeing to take part in the study | Study duration - up to one year | 
| Feasibility - recruitment rate | We define a successful recruitment rate as achieving enrolment of four patients per month over the duration of the trial | Study duration - up to one year | 
| Feasibility - protocol adherence | We define successful adherence as average family involvement in ≥ 3 sessions/week. Furthermore, adherence to documentation of involvement will be successful if documented by family for ≥80% of sessions | During ICU stay, censored at 1 month | 
| Feasibility - resources | Physiotherapist and nurse outcomes will include inability to train families due to physiotherapy or team resources, and number of sessions per week cancelled due to inadequate staffing resources during the patients ICU stay. | Study duration - up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Delirium | CAM-ICU | During ICU stay, censored at 1 month | 
| Patient & Family PTSD symptoms | IES-R | 1 & 3 months | 
| Adverse Events | Falls, hypotension, bradycardia, line removal, unplanned extubation, inappropriate family intervention, unexpected injuries | During ICU stay, censored at 1 month | 
| Family satisfaction | 23-item Family Satisfaction in the ICU questionnaire; HADS scale | 1 & 3 months |