Enhanced Vitals Monitoring After Major Surgery Trial
NCT Number: NCT06584825
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgery|Post Operative Complications|Quality of Recovery|General Surgery|Vascular Surgery|Urology|Gynecology
Sponsor: University of British Columbia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-03
Completion Date: 2025-03-31

Summary:
The aim of this clinical trial is to examine the feasibility of an enhanced vital sign monitoring solution in-hospital and at-home. This study includes adult patients undergoing inpatient medium- to high-risk vascular or abdominal surgery. Researchers will compare the enhanced vitals monitoring group to the standard of care group to see if it may change post-operative management and outcomes. The primary question it aims to answer is if enhanced monitoring of surgical patient vitals can increase the number of days at home alive in the first 30 days after surgery. Participants in the intervention group will test two vitals monitoring devices, one in the hospital and one at home. They will also be asked to complete several questionnaires and a follow up phone call.

Primary Outcome Measures: Days Alive At Home (DAH30), Number of days within 30 days of surgery when participants are alive and at home, without visiting an emergency department or urgent care centre or being admitted to a hospital. Home refers to their own home, or a residence of a relative, friend or acquaintance, but excludes a nursing home or a rehabilitation facility.

If a participant visits an emergency department or urgent care centre, or is admitted to a hospital any time between midnight and 23:59 on a given day, they will lose that day as a day alive at home. If they remain in the care facility past midnight into the next day, then they lose 2 days alive at home. They will continue to lose days alive at home until the day in which they are home from midnight for an entire day. In other words, a day alive at home can be counted only when participants spend an entire day from midnight to 23:59 at home, without being stay at an emergency department, an urgent-care centre or a hospital., Within 30 days after surgery, with the day of surgery as day 0
Secondary Outcome Measures: Major Morbidity, Complications associated with 30-day mortality: major bleeding, myocardial injury after noncardiac surgery (includes myocardial infarction), myocardial infarction (3rd Universal Definition), sepsis, infection without sepsis, acute kidney injury with new dialysis, stroke, venous thromboembolism and congestive heart failure) within 30 days postoperatively, Within 30 days after surgery, with the day of surgery as day 0|Mortality, All cause mortality within 30 days of surgery, Within 30 days after surgery, with the day of surgery as day 0|Emergency Department visit(s) after discharge, This outcome describes if a participant visited an emergency department after discharge within 30 days of surgery, and if so, a count of how many times., Within 30 days after surgery, with the day of surgery as day 0|Readmission(s), This outcome describes if a participant was readmitted to hospital after initial discharge from hospital within 30 days of surgery, and if so, for how long and how many times., Within 30 days after surgery, with the day of surgery as day 0|Urgent walk-in clinic visit(s), This outcome describes if a participant visited an urgent walk-in clinic after discharge within 30 days of surgery, and if so, a count of how many times., Within 30 days after surgery, with the day of surgery as day 0|Family doctor clinic visit(s), This outcome describes if a participant visited a family doctor clinic after discharge within 30 days of surgery, and if so, a count of how many times. This will include details of planned (for suture/staple removal, or other reason) vs. unplanned, Within 30 days after surgery, with the day of surgery as day 0|Surgeon clinic contact(s), This outcome describes if a participant visited their surgeon after discharge within 30 days of surgery, and if so, a count of how many times. This will also include details of whether it was a planned (for suture/staple removal, or other reason) vs. unplanned visit and an email, phone call or clinic visit., Within 30 days after surgery, with the day of surgery as day 0|Post-Operative Length of Stay, The amount of time a patient is in hospital after their operation., The time from the date of the surgery to the date of discharge from the hospital, up to 30 days after surgery|Quality of Recovery at 10 days postoperatively, Measured using the Quality of Recovery-15 (QoR-15) score. QoR-15 scale is a validated tool to assess the quality of postoperative recovery. It consists of 15 likert questions in two parts.

Part A consists of 10 questions asking a patient how they have been feeling in the previous 24 hours with regards to factors such as sleeping and eating. Responses are given on an 11 point likert scale from 0 to 10, where 0 is none of the time \[poor\] and 10 is all of the time \[excellent\].

Part B consists of five questions which ask the patient if they have experienced specific adverse events (for example, pain, nausea/vomiting or anxiety). Responses are given on an 11 point likert scale from 10 to 0, where 10 is none of the time \[excellent\] and 0 is all of the time \[poor\].

This questionnaire is administered either over the phone, online or on paper., 10 days after surgery|Quality of Recovery at 30 days postoperatively, Measured using the Quality of Recovery-15 (QoR-15) score. QoR-15 scale is a validated tool to assess the quality of postoperative recovery. It consists of 15 likert questions in two parts.

Part A consists of 10 questions asking a patient how they have been feeling in the previous 24 hours with regards to factors such as sleeping and eating. Responses are given on an 11 point likert scale from 0 to 10, where 0 is none of the time \[poor\] and 10 is all of the time \[excellent\].

Part B consists of five questions which ask the patient if they have experienced specific adverse events (for example, pain, nausea/vomiting or anxiety). Responses are given on an 11 point likert scale from 10 to 0, where 10 is none of the time \[excellent\] and 0 is all of the time \[poor\].

This questionnaire is administered either over the phone, online or on paper., 30 days after surgery with the day of surgery as day 0
Other Outcome Measures: Completion of the intervention, The primary feasibility outcome is defined as more than 80% of participants completing the monitoring protocol, with a priori definition of the completion being monitoring in-hospital and at home each for 3 times a day for 3 days (or the duration of the hospital stay, whichever is shorter)., 30 days after surgery with the day of surgery as day 0|Participant Recruitment Rate, The proportion of patients recruited who provided consent out of all meeting the clinical inclusion criteria, Preoperatively, at the time of recruitment, up to 1 month prior to surgery.|Participant Exclusion Rate, The proportion of patients excluded out of all patients screened, Preoperatively, at the time of screening and recruitment, up to 1 month prior to surgery.|Participant Withdrawal Rate, The proportion of patients who withdrew from the study out of all enrolled patients., Preoperatively, at the time of recruitment, up to 30 days post-operatively|Participant patterns of use of monitoring devices, How frequently did patients use the monitoring devices and for what duration. This will be based on data collected from the devices., Up to 30 days after surgery, with the day of surgery as day 0|Device issues encountered, Issues that participants reported encountering with the monitoring devices. Reported as an open ended question in the patient daily log sheet, Up to 30 days after surgery, with the day of surgery as day 0|Reasons for device removal, What were the reasons that patients took the monitors on and off (e.g. charging/battery life, showers, eating, mobilization/physiotherapy) as reported as an open ended question in the patient daily log sheet, Up to 30 days after surgery, with the day of surgery as day 0|Interruptions in vitals monitoring, Description of instances of interruption in monitoring that were more than 4 hours, Up to 30 days after surgery, with the day of surgery as day 0|In-Hospital Enhanced Monitoring Device System Usability Scale, Patient feedback about enhanced monitoring device usability of the in-hospital enhanced monitoring device. The System Usability Scale (SUS) is a patient-reported measurement which includes ten 5-point likert scale questions from 1 to 5, with one being strongly disagree and 5 being strongly agree. The suitability of using SUS for evaluating medical devices has been well established., At the time of discharge from hospital, from 2 to 30 days postoperatively|At-Home Enhanced Monitoring Device System Usability Scale, Patient feedback about enhanced monitoring device usability of the in-hospital enhanced monitoring device. The System Usability Scale (SUS) is a patient-reported measurement which includes ten 5-point likert scale questions from 1 to 5, with one being strongly disagree and 5 being strongly agree. The suitability of using SUS for evaluating medical devices has been well established., 30 days after surgery, with the day of surgery as day 0|Care escalation frequency, The frequency of vital sign derangements detected by enhanced monitoring and the resulting care escalation categorized by type of vital measure within the duration of monitoring. This will be determined based on data from the devices and as reported by the patients nurse., Up to 30 days after surgery, with the day of surgery as day 0|Response time, Time between vital sign alert and care escalation. This will be determined based on data from the devices and as reported by the patients nurse.

xii. logistics of device use (time spent on education, initiation, discontinuation, cleaning, collection, and troubleshooting of devices) xiii. issues that arise in the workflow, Up to 30 days after surgery, with the day of surgery as day 0|Logistics of Enhanced Monitoring Implementation, Description of the logistics of implementing the intervention. This includes a description of time spent on education, initiation, discontinuation, cleaning, collection, and troubleshooting of the devices by the study coordinator., Up to 30 days after surgery, with the day of surgery as day 0|Workflow Issues, A qualitative description of issues that arise in the workflow of implementing the intervention., Up to 30 days after surgery, with the day of surgery as day 0|Adverse Events, Any patient-reported adverse events, Up to 30 days after surgery, with the day of surgery as day 0|Patient Feedback, An evaluation of potential harm or safety issues gathered from a feedback questionnaire filled out by the participant at the end of the enhanced monitoring period. The Feedback questionnaire uses a 5 point likert scale (1-5), where 1 = Strongly disagree...3 = Neutral...5 = Strongly agree. The questionnaire asks patients to rate how they feel about the following statements:

i. Their ability to move around after surgery ii. Their daily activities (e.g. going to the bathroom, eating, showering) iii. Making them anxious about your health? There is also one open ended question for participants to add any other feedback they have related to enhanced monitoring, 30 days after surgery, with the day of surgery as day 0|Study Costs, Overall study costs spent and difference of costs between intervention group and standard care group, Pre-study and up to time of publication|Questionnaire Completion, Completion rates of all questionnaires administered, From time of enrollment to 30 days after surgery with the day of surgery as day 0|Method of Questionnaire Completion, Number of participants that completed questionnaires over the phone, online or on paper., From time of enrollment to 30 days after surgery with the day of surgery as day 0|Support needed for questionnaires, Number of participants that required either caregiver or family member or technical support to complete questionnaires., From time of enrollment to 30 days after surgery with the day of surgery as day 0