Virtual Care for Frailty After Surgery

(VICTORY Trial)

Overseen By Emily Hladkowicz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Preoperative institutional residence, cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment CloudDX technology for frailty after surgery?

Research shows that rehabilitation strategies after surgery can improve outcomes for frail patients by building strength. Additionally, preoperative exercise, like walking with an activity tracker, can enhance stamina and mobility, which may help in recovery after surgery. ^{1 2 3 4 5}

How is the CloudDX technology treatment unique for managing frailty after surgery?

CloudDX technology offers a novel approach by utilizing virtual care to monitor and manage frailty after surgery, potentially providing continuous and remote support that traditional in-person methods may not offer. This technology leverages electronic health data to assess frailty, which can be more efficient and less resource-intensive compared to conventional frailty screening tools. ^{2 5 6 7 8}

Research Team

Sylvie Aucoin, MD

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

The VICTORY trial is for people over 60 with frailty (Clinical Frailty Score >4) who are scheduled for elective surgery and speak English. It's not specified who can't join, but typically those with conditions that could interfere with virtual care or follow-up might be excluded.

Inclusion Criteria

I have been diagnosed as frail.

I am over 60 years old.

I am fluent in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive virtual care from the VRAS nursing and anesthesiologist team following surgical discharge, facilitated by Cloud DX software and monitoring equipment.

2 weeks

Video visits on post-discharge days 1, 3, 5, 7, and every other day until day 14 if needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life, medication issues, and incidence of post-discharge falls.

4 weeks

Long-term follow-up

Participants' resource use and patient-centered outcomes are monitored up to 1 year post-surgery.

1 year

Treatment Details

Interventions

• CloudDX technology

Trial Overview This study tests if virtual care using CloudDX technology improves the number of days older adults with frailty spend at home after planned surgery, compared to standard post-surgical care. Participants will receive either the new virtual care method or usual care.

Participant Groups

Group I: Virtual Care Experimental Treatment 1 Intervention

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.

Group II: Standard Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Findings from Research

A novel prehabilitation program for frail patients before major surgery was found to be feasible and led to significant improvements in functional performance, such as increased gait speed and walking distance, in a study of 43 participants.

The intervention, which included strength training, respiratory muscle training, and nutritional coaching, resulted in clinically meaningful enhancements in physical capabilities, suggesting it could positively influence recovery and surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Rehabilitation Is Feasible in the Weeks Prior to Surgery and Significantly Improves Functional Performance. Hall, DE., Youk, A., Allsup, K., et al.[2023]

In a study of 295 vascular surgery patients, those classified as frail based on an automated electronic frailty index (eFI) were significantly more likely to be discharged to an acute care facility rather than home, indicating a higher risk of adverse outcomes.

Frail patients also had a higher prevalence of comorbidities and were more likely to be classified as high-risk by the American Society of Anesthesiologists, highlighting the importance of frailty assessment in surgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Electronic Frailty Index is Associated with Non-home Discharge in Patients Undergoing Open Revascularization for Peripheral Vascular Disease. Stutsrim, AE., Brastauskas, IM., Craven, TE., et al.[2023]

In a study of 308 older surgical patients, those classified as 'vulnerable' or 'frail' had significantly higher rates of readmission or death within 30 days after discharge, with adjusted odds ratios of 4.60 and 4.51, respectively, compared to 'well' patients.

The degree of frailty was shown to be a strong predictor of readmission or death up to 6 months post-surgery, indicating that frailty assessments could be crucial for improving patient outcomes in older adults after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of frailty on outcomes after discharge in older surgical patients: a prospective cohort study. Li, Y., Pederson, JL., Churchill, TA., et al.[2019]

Frailty significantly increases the risk of adverse outcomes in general surgical patients, with a 30-day mortality rate of 8% for frail patients compared to just 1% for non-frail patients, based on a systematic review of 2,281 participants from nine studies.

Frail patients also experience higher rates of surgical complications (24%) and longer hospital stays (average of 9.6 days) compared to non-frail patients (5% complications and 6.4 days stay), highlighting the need for careful management of frail individuals undergoing surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence of frailty and its association with clinical outcomes in general surgery: a systematic review and meta-analysis. Hewitt, J., Long, S., Carter, B., et al.[2019]

A walking intervention using an activity tracker and coaching did not improve postoperative stamina or mobility in frail older adults, as measured by the 6-minute walk distance and steps taken after surgery.

In a study of 104 patients aged 60 and older, the intervention group showed no significant differences in recovery outcomes compared to the control group, suggesting that this specific preoperative exercise approach may not be effective for enhancing postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised preoperative walking on increasing early postoperative stamina and mobility in older adults with frailty traits: A pilot and feasibility study. Rampam, S., Sadiq, H., Patel, J., et al.[2022]

Frailty identified through electronic medical data significantly increases the risk of mortality by 3.57 times and is also linked to higher odds of institutional discharge and increased healthcare costs, based on a meta-analysis of 90 studies.

The review highlighted that most frailty assessment instruments used in electronic data are not multidimensional, indicating a need for future research to explore more comprehensive tools and their practical application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of Preoperative Frailty Instruments Derived From Electronic Health Data. Alkadri, J., Hage, D., Nickerson, LH., et al.[2023]

A survey of 168 emergency surgeons revealed that while 98.2% recognized the importance of frailty in surgical patients, only 2.4% actually performed comprehensive geriatric assessments, indicating a significant gap between awareness and practice.

Key barriers to implementing effective frailty management included a lack of knowledge about assessment tools, unclear responsibilities for screening, and insufficiently trained staff, suggesting that improved training and guidelines could enhance frailty care in emergency surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions and practices surrounding the perioperative management of frail emergency surgery patients: a WSES-endorsed cross-sectional qualitative survey. Viswanath, M., Clinch, D., Ceresoli, M., et al.[2023]

In a study of 230 surgical patients aged 60 and older, those who reported signs of frailty, such as fatigue and weight loss, were significantly more likely to be discharged to a post-acute facility rather than home, with an odds ratio of 4.5 for those with a FRAIL screen score of 2 or higher.

The FRAIL screening tool effectively identifies patients at risk for non-home discharge, suggesting it could be a valuable part of preoperative assessments to improve discharge planning and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Patient-Reported Frailty and Non-Home Discharge Among Older Adults Undergoing Surgery. Sokas, CM., Cowan, J., Dalton, MK., et al.[2022]

References

1. France pubmed.ncbi.nlm.nih.gov

Preoperative Rehabilitation Is Feasible in the Weeks Prior to Surgery and Significantly Improves Functional Performance. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Automated Electronic Frailty Index is Associated with Non-home Discharge in Patients Undergoing Open Revascularization for Peripheral Vascular Disease. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Impact of frailty on outcomes after discharge in older surgical patients: a prospective cohort study. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The prevalence of frailty and its association with clinical outcomes in general surgery: a systematic review and meta-analysis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Supervised preoperative walking on increasing early postoperative stamina and mobility in older adults with frailty traits: A pilot and feasibility study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of Preoperative Frailty Instruments Derived From Electronic Health Data. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Perceptions and practices surrounding the perioperative management of frail emergency surgery patients: a WSES-endorsed cross-sectional qualitative survey. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Association Between Patient-Reported Frailty and Non-Home Discharge Among Older Adults Undergoing Surgery. [2022]