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

Not Applicable

Recruiting

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
All participants	Family involvement	Patients to receive mobility interventions from trained family members

Primary Outcome Measures

Name	Time	Method
Feasibility - resources	Study duration - up to one year	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.
Feasibility - recruitment rate	Study duration - up to one year	We define a successful recruitment rate as achieving enrolment of four patients per month over the duration of the trial
Feasibility - protocol adherence	During ICU stay, censored at 1 month	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
Feasibility - consent rate	Study duration - up to one year	We define a successful consent rate as \> 70% of SDMs or patients approached to consent, agreeing to take part in the study

Secondary Outcome Measures

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

Locations (3): Brant Community Healthcare System
🇨🇦
Brantford, Ontario, Canada
Juravinski Hospital
🇨🇦
Hamilton, Ontario, Canada
St Joseph's Healthcare Hamilton
🇨🇦
Hamilton, Ontario, Canada