Virtual Care to Improve Post-Intensive Care Syndrome (VPICS)
Primary Purpose
Post Intensive Care Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
VPICS Clinic
Sponsored by
About this trial
This is an interventional health services research trial for Post Intensive Care Syndrome
Eligibility Criteria
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
Sites / Locations
- The Ottawa Hospital
- Montfort Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Clinic participation
Outcomes
Primary Outcome Measures
Creation of a feasible virtual model of PICS care.
Measured by participant focus groups concerning participation, attrition, adherence, engagement, perceived value.
Secondary Outcome Measures
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).
Participant satisfaction
Measured by focus group thematic analysis.
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.
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.
Full Information
NCT ID
NCT05597007
First Posted
October 25, 2022
Last Updated
October 25, 2022
Sponsor
Hopital Montfort
Collaborators
The Ottawa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05597007
Brief Title
Virtual Care to Improve Post-Intensive Care Syndrome
Acronym
VPICS
Official Title
Virtual Care to Improve Post-Intensive Care Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Montfort
Collaborators
The Ottawa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Intensive Care Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Clinic participation
Intervention Type
Behavioral
Intervention Name(s)
VPICS Clinic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Creation of a feasible virtual model of PICS care.
Description
Measured by participant focus groups concerning participation, attrition, adherence, engagement, perceived value.
Time Frame
Measured at Month 12
Secondary Outcome Measure Information:
Title
Participant satisfaction
Description
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).
Time Frame
Measured at Month 12
Title
Participant satisfaction
Description
Measured by focus group thematic analysis.
Time Frame
Measured at Month 12
Title
Increased participant quality of life.
Description
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.
Time Frame
Baseline and Month 12
Title
Increased participant quality of life.
Description
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.
Time Frame
Baseline and Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kwadwo Kyeremanteng, MD
Phone
6132630957
Email
kwadwo77@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Hajjar, MSc
Email
jhajj058@uottawa.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwadwo Kyeremanteng, MD
Organizational Affiliation
Hôpital Montfort
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwadwo Kyeremanteng, MD
Phone
6132630957
Email
kkyermanteng@toh.ca
Facility Name
Montfort Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1K0T1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Psarras, MD
Phone
6136085255
Email
tompsarras@montfort.on.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Virtual Care to Improve Post-Intensive Care Syndrome
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