Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503198
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
The VICTORY Trial Virtual Innovative Postsurgical Care To Optimize Return Home for Older People With frailtY
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Virtual Innovative Postsurgical Care To Optimize Return Home for Older People With frailtY the VICTORY Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VICTORY
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
Detailed Description:
Background Each year 130000 older Canadians living with frailty have major inpatient surgery The presence of frailty a multidimensional state of vulnerability is strongly associated with adverse outcomes Compared to similar patients without frailty surgical patients with frailty experience a 2- to 5-fold adjusted increase in the odds of mortality complications patient-reported disability length of stay readmissions and non-home discharge However despite the growing number of patients with frailty presenting for surgery each year a recent systematic review from our team demonstrates that there are no evidence-based frailty-specific interventions available to drive improvements in outcomes for this vulnerable population A promising intervention to support independence and maintain older people at home after surgery is Virtual Recovery After Surgery VRAS an innovative multidisciplinary program that has been providing post-discharge remote monitoring and virtual care for surgical patients since 2021 Patients receive virtual care from the VRAS nursing and anesthesiologist team following surgical discharge facilitated by Cloud DX software and monitoring equipment Based on our teams joint expertise in frailty and Postoperative Virtual Care PVC the investigators have identified 1 a crucial gap in care expressed by older patients with frailty the need for support and continuity of care via telehealth resources to support transition of care to their homes and 2 an intervention that could directly fill this gap frailty tailored PVC
Overarching Aim The objective of the VICTORY Trial is to determine 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 in the 30 days after planned surgery A secondary aim is to estimate the probability that enrollment in a frailty-tailored PVC program will reduce healthcare resource use and improve patient-reported outcomes and safety
Methods
Design setting and participants The VICTORY Trial is a multicenter innovative clinical trial using an individual patient parallel-arm randomized controlled trial design of 1000 older patients living with frailty being discharged from hospital after elective surgery
People 60 years old with frailty having elective surgery will be included
Intervention Patients randomized to the PVC program will be monitored at home by virtual nurses for at least 7 days after hospital discharge Participants will be provided with a hospital-to-home kit that contains the following technologies tablet computer with stand wrist-based blood pressure cuff for blood pressure pulse and breathing rate finger worn pulse oximeter for measuring oxygen levels thermometer for temperature and weigh scale to monitor weight Monitoring will include video visits with a nurse on post-discharge days 1 3 5 and 7 and every other day until post-discharge day 14 if needed Patients will be asked to complete a daily survey that will include questions about any symptoms they may be experiencing their independencedependence with activities of daily living and their experience with the PVC program Depending on the patients recovery including the assessments and surveys described patients may receive information electronically on how to manage certain challenges ie confusion not eating enough their care may be escalated to a physician or they may be instructed to come to the hospital
Outcomes and sample size The primary outcome is the number of days that each patient spends alive and at home following surgery Secondary outcomes are resource use index length of stay readmission total hospital days emergency department visits time to first acute hospital care cost of care patient-centered outcomes delirium 4AT quality of life EQ- 5D-5L pain interference PROMIS satisfaction likelihood to recommend goal attainment and overall quality of transitional care received safety medication issues incidence of post-discharge falls
Based on trial simulations the investigators estimate that the most likely number of participants required will be 1000 500 per arm which is adequate to achieve at least 90 power to declare superiority defined as probability of any benefit 99 POdds Ratio OR1 99 when the effect size expressed as an OR from a cumulative logistic model is 15 and the control group number of days alive at home within 30 days is 16
Expertise Our team features multidisciplinary clinical and methodological experts nationally representative knowledge users and patient representatives
Expected outcomes The VICTORY Trial will 1 advance the practice of PVC using evidence-based frailty-tailored approaches 2 evaluate this frailty-tailored PVC intervention in direct partnership with patients and 3 produce robust potentially practice-changing research using innovative clinical trial methodologies that will inform implementation
Overarching Aim The objective of the VICTORY Trial is to determine 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 in the 30 days after planned surgery A secondary aim is to estimate the probability that enrollment in a frailty-tailored PVC program will reduce healthcare resource use and improve patient-reported outcomes and safety
Methods
Design setting and participants The VICTORY Trial is a multicenter innovative clinical trial using an individual patient parallel-arm randomized controlled trial design of 1000 older patients living with frailty being discharged from hospital after elective surgery
People 60 years old with frailty having elective surgery will be included
Intervention Patients randomized to the PVC program will be monitored at home by virtual nurses for at least 7 days after hospital discharge Participants will be provided with a hospital-to-home kit that contains the following technologies tablet computer with stand wrist-based blood pressure cuff for blood pressure pulse and breathing rate finger worn pulse oximeter for measuring oxygen levels thermometer for temperature and weigh scale to monitor weight Monitoring will include video visits with a nurse on post-discharge days 1 3 5 and 7 and every other day until post-discharge day 14 if needed Patients will be asked to complete a daily survey that will include questions about any symptoms they may be experiencing their independencedependence with activities of daily living and their experience with the PVC program Depending on the patients recovery including the assessments and surveys described patients may receive information electronically on how to manage certain challenges ie confusion not eating enough their care may be escalated to a physician or they may be instructed to come to the hospital
Outcomes and sample size The primary outcome is the number of days that each patient spends alive and at home following surgery Secondary outcomes are resource use index length of stay readmission total hospital days emergency department visits time to first acute hospital care cost of care patient-centered outcomes delirium 4AT quality of life EQ- 5D-5L pain interference PROMIS satisfaction likelihood to recommend goal attainment and overall quality of transitional care received safety medication issues incidence of post-discharge falls
Based on trial simulations the investigators estimate that the most likely number of participants required will be 1000 500 per arm which is adequate to achieve at least 90 power to declare superiority defined as probability of any benefit 99 POdds Ratio OR1 99 when the effect size expressed as an OR from a cumulative logistic model is 15 and the control group number of days alive at home within 30 days is 16
Expertise Our team features multidisciplinary clinical and methodological experts nationally representative knowledge users and patient representatives
Expected outcomes The VICTORY Trial will 1 advance the practice of PVC using evidence-based frailty-tailored approaches 2 evaluate this frailty-tailored PVC intervention in direct partnership with patients and 3 produce robust potentially practice-changing research using innovative clinical trial methodologies that will inform implementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None