Virtual Care to Improve Post-Intensive Care Syndrome (VPICS)

The goal of this interventional trial is to learn about whether a virtual clinic can help patients with post-intensive care unit syndrome regain functional ability. Participants will participate in a 12-month online clinic where they will receive physiotherapy, nutritional planning, mental health support and cognitive strengthening. Functional capacity will be measured throughout the clinic. After, they will be asked questions about their clinic experience, and complete a questionnaire.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Intensive Care Syndrome
• Intervention / Treatment: Behavioral: VPICS Clinic

Detailed Description

Virtual Care to Improve Post-Intensive Care Syndrome (V-PICS) is a multidisciplinary virtual clinic designed to address the three components of post-intensive care syndrome (PICS): physical impairment, cognitive decline and mental health challenges. This initiative targets ICU survivors who received mechanical ventilation for a minimum of 48 hours. Referred patients will access live sessions with healthcare professionals who will guide at-home strategies to address PICS including physiotherapy, nutritional planning, mental health support and cognitive strengthening. The clinic will provide an integrated approach to addressing the challenges faced by ICU survivors. The feasibility of this virtual clinic will be assessed by measuring patient satisfaction, clinic effectiveness and levels of engagement and attendance. The study's findings will inform the creation of a robust multi-centre clinical trial that will contribute to the creation of a national standard of PICS care and increase health system efficiencies.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kwadwo Kyeremanteng, MD; Phone Number: 6132630957; Email: kwadwo77@gmail.com
• Study Contact Backup: Name: Julia Hajjar, MSc; Email: jhajj058@uottawa.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
      • Contact: Kwadwo Kyeremanteng, MD; Phone Number: 6132630957; Email: kkyermanteng@toh.ca
    • Ottawa, Ontario, Canada, K1K0T1
      • Montfort Hospital
      • Contact: Tom Psarras, MD; Phone Number: 6136085255; Email: tompsarras@montfort.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• over 18 years of age
• received mechanical ventilation for a minimum of 48 hours in the ICU
• discharged from the hospital in the 2 months prior to study start

Exclusion Criteria:

• Individuals originating from an assisted living/ long-term care facility
• lack a capacity for informed consent
• have end-stage illnesses
• present a significant fall risk
• cannot speak English or French
• do not have the technological skills or caregiver support to ensure digital literacy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• 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: Treatment; Clinic participation

Behavioral: VPICS Clinic; Participants will complete a mix of mandatory synchronous and asynchronous sessions with their Health Group to address PICS. Participants will spend 15 minutes daily on physiotherapy, and 15 minutes on cognitive therapy. There are also 2h time slots everyday for participants to join for an optional check-in with their health coach, who can support them in their individual activities. Participants will spend 15 minutes weekly responding to journal prompts about nutrition and general challenges.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creation of a feasible virtual model of PICS care.	Measured by participant focus groups concerning participation, attrition, adherence, engagement, perceived value.	Measured at Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction	Measured by the Canadian Health Care Evaluation Project (CANHELP) survey. The validated questionnaire assesses healthcare satisfaction in elderly patients with life-limiting illnesses. This abbreviated 15-item questionnaire contains questions pertaining to trust in healthcare providers, sense of dignity, quality of communication and confidence in planning for future healthcare needs. Each question has 5 options for level of agreement with a given statement (Not at all, not very, somewhat, very, completely).	Measured at Month 12
Participant satisfaction	Measured by focus group thematic analysis.	Measured at Month 12
Increased participant quality of life.	Measured by the Functional Independence Measure (FIM). The validated FIM consists of 18 questions and addresses six motor and cognitive functional areas. Each element of the FIM is rated on a scale of 1 to 7, with 7 signifying complete independence.	Baseline and Month 12
Increased participant quality of life.	Measured by the Patient Reported Outcomes Measurement Information System (PROMIS). The PROMIS examines physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles and activities, pain interference/intensity. The PROMIS-29 questionnaire has 29 questions rated on scales of 1 to 5 or 1 to 10.	Baseline and Month 12

Collaborators and Investigators

• Sponsor: Hopital Montfort
• Collaborators: The Ottawa Hospital
• Investigators: Principal Investigator: Kwadwo Kyeremanteng, MD, Hopital Montfort

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 20220547-01H

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