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

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium; Critical Illness
• Intervention / Treatment: Other: Family involvement

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Recruiting
      • St Joseph's Healthcare Hamilton
      • Principal Investigator: Kimberley Lewis, MD
      • Contact: Jose Estrada; Phone Number: 32873 905-522-1155; Email: jestrada@stjosham.on.ca
      • Sub-Investigator: Laiya Carayannopoulos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All participants; Patients to receive mobility interventions from trained family members	Other: Family involvement; Family delivery of mobility activities

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 15669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No