Clinical trial NCT06071793: Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study
Official title: Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Critical Illness
Delirium
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility - consent rate
timeFrame: Study duration - up to one year
measure: Feasibility - recruitment rate
timeFrame: Study duration - up to one year
measure: Feasibility - protocol adherence
timeFrame: During ICU stay, censored at 1 month
measure: Feasibility - resources
timeFrame: Study duration - up to one year
Secondary outcomes:
measure: Patient Delirium
timeFrame: During ICU stay, censored at 1 month
measure: Patient & Family PTSD symptoms
timeFrame: 1 & 3 months
measure: Adverse Events
timeFrame: During ICU stay, censored at 1 month
measure: Family satisfaction
timeFrame: 1 & 3 months
Other outcomes:
Locations:
city: Brantford
country: Canada
facility: Brant Community Healthcare System
state: Ontario
city: Hamilton
country: Canada
facility: St Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
Study officials:
affiliation: The Research Institute of St Joe's Hamilton
name: Kimberley Lewis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Research Institute of St Joe's Hamilton
name: Laiya Carayannopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References: