Recruiting

Virtual Care

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT06503198

Conditions

Surgery

Frailty

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Virtual care

Study Details

Brief summary:

Canadian hospitals continue to struggle with severe emergency department and hospital bed capacity shortages. Maximizing bed availability and minimizing emergency department and urgent-centre visits by providing patients with alternative options to care is an important part of the solution. Surgical patients with frailty are at high risk of requiring subsequent acute-hospital care. The VICTORY trial will answer an important question that will inform how to improve care for surgical patients with frailty by determining the effect of virtual care with CloudDX technology compared to standard care to see if it can result in an increase in the number of days alive and at home that older people with frailty experience after planned surgery.

Conditions

Surgery

Frailty

Study ID

NCT06503198

Start date

Jan 29, 2025

Status verified date

Jan, 2025

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age > 60years
2. Diagnosis of frailty (Clinical Frailty Score >4)
3. Elective surgery
4. Fluent in English

Exclusion Criteria:

1. Preoperative institutional residence
2. Planned postoperative non-home discharge (i.e. rehabilitation or convalescence)
3. Patient unable to interact with virtual care and/or technology
4. Cognitive impairment preventing ability to provide independent informed consent to surgery and the trial
5. Patient lives in an area without cellular or internet service

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual Care

Intervention group participants will be enrolled in a PVC program prior to admission, including receipt of a cellular-enabled tablet and Cloud DX remote monitoring equipment.

Through Cloud DX remote monitoring technology, intervention group participants will receive the following intervention: remote automated monitoring, frailty-tailored daily symptom survey, Katz Index of Independence in Activities of Daily Living survey, FAM-CAM survey, Virtual RN assessment, medications.

no intervention: Standard Care

The standard care group will receive their post-hospital discharge management in alignment with standard of care at the hospital where they had surgery.

Interventions

Virtual care

Through Cloud DX, intervention group participants will receive:

Remote Automated Monitoring: measurement of: blood pressure, heart rate, respiratory rate, oxygen saturation, temperature and weight.

Frailty-tailored daily symptom survey: The recovery survey consists of questions related to infection, bleeding, pain, appetite, dehydration, appetite, syncope and falls.

The tablet will prompt the participant to complete a Katz Index of Independence in Activities of Daily Living (IADL) survey. The FAM-CAM survey will also be pushed by Cloud DX to be completed.

Virtual RN assessment: a virtual RN assessment will be scheduled at a minimum of every 2 days for the first 7 days. The virtual RN will also perform the 4AT Delirium Assessment.

Medications: the virtual RN will undertake medication review and reconciliation. In addition, they will provide counselling regarding analgesic support and monitor for drug interactions.

Primary outcome measure

  • Number of days each patient spends alive and at home following surgery [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Emily Hladkowicz, PhD

613-798-5555emhladkowicz@toh.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1Y1J8

Contacts

Emily Hladkowicz, PhD

613-798-5555emhladkowicz@toh.ca

Principal Investigator:

Sylvie Aucoin, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Feb 4, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-02-04.