Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology-3 Trial

Surgery Clinical Trial

— PVC-RAM-3  

Official title:

Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology-3 (PVC-RAM-3) Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05171569
• Other study ID #: v1.0_2021-12-22
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2021
• Est. completion date: February 7, 2025

Study information

• Verified date: November 2023
• Source: Population Health Research Institute
• Contact: Stephanie Harrison, BAS
• Phone: 905-521-2100
• Email: stephanie.harrison[@]phri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM)-3 Trial is a multicentre, parallel group, superiority, randomized controlled trial to determine the effect of virtual care with remote automated monitoring (RAM) technology compared to standard care on length of index hospital stay after randomization, in adults who have undergone elective non cardiac surgery. Secondary outcomes at 30 days after randomization include 1) acute hospital care (composite of hospital readmission and emergency department visit) 2) hospital re-admission; 3) emergency department visit; 4) medication error detection; 5) medication error correction; 6) surgical site infection; and 7) days in hospital. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 15 and 30 days after randomization. The investigators will also assess optimal management of long-term health by evaluating among patients with atherosclerotic disease and current smokers whether patients are taking classes of efficacious medications at 30 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: February 7, 2025
• Est. primary completion date: January 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. are =18 years of age;

2. are undergoing inpatient elective noncardiac surgery with an expected length of hospital stay =3 days after surgery; and

3. provide informed consent to participate.

Exclusion Criteria:

1. are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to a language barrier or a cognitive, visual, or hearing impairment; or

2. reside in an area without cellular network coverage.

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Virtual care with remote automated monitoring (RAM)
Use of Cloud Diagnostics connected health kit for at home monitoring with virtual clinical from nursing and perioperative physician team.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Juravinski Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infection	Infection is defined as a pathologic process caused by the invasion of normally sterile tissue, fluid, or body cavity by pathogenic or potentially pathogenic organisms.	30 days post randomization
Other	Re-operation	Re-operation refers to any surgical procedure undertaken for any reason (e.g., wound dehiscence, infection).	30 days post randomization
Other	composite of myocardial infarction, acute heart failure, and arrhythmia that results in acute hospital care	The diagnosis of myocardial infarction requires criteria meeting 4th universal definition of myocardial infarction.; The definition of acute heart failure requires at least one of the following clinical signs (i.e., elevated jugular venous pressure, respiratory rales or crackles, crepitations, or presence of S3) with at least one of the following: radiographic findings of vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema, OR; heart failure treatment with a diuretic and documented clinical improvement.; Any arrhythmia that results in patient presenting to an emergency department, which includes an urgent care centre visit or being admitted to hospital.	30 days post randomization
Other	Death	All cause mortality	30 days post randomization
Other	Health related quality of life (HRQoL)	HRQoL will be measured with the EQ-5D-5L instrument (https://euroqol.org/eq-5d-instruments/sample-demo) due to its increased sensitivity and validation in several countries including Canada.4 The EQ-5D-5L is also recommended in Canada5 to calculate the Quality Adjusted Life Years (QALYs) when conducting cost-effectiveness analyses.	30 days post randomization
Other	Health services utilization-related costs	Data on hospital re-admission, length of stay, and healthcare utilization will be obtained from the Ontario Hospital Association Integrated Decision Support (IDS) database. IDS is a comprehensive platform with an integrated view of patient activity, allowing for access to health systems data for any patients enrolled. Data on costs of health service utilization will be obtained from the Ontario Case Costing Database.	30 days post randomization
Primary	Index hospital length of stay	Length of stay from randomization until discharge from the index hospitalization (measured in days and hours)	30 Days post randomization
Secondary	Acute hospital care (composite of hospital readmission and emergency department visit)	Acute-hospital care is a composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.	30 Days post randomization
Secondary	Hospital readmission	Patient admission to an acute-care hospital.	30 days post randomization
Secondary	Emergency department visit (includes urgent care centre visit)	Patient visit to an emergency department, which includes urgent-care centre visit.	30 days post randomization
Secondary	Medication error detection	Medication errors include mistakes in medication prescribing, transcribing, dispensing, administering, or monitoring due to preventable events or actions taken by a patient, caregiver, or healthcare worker. Medication errors include: drug omission (i.e., patient did not take a drug they were supposed to take), drug commission (i.e., patient taking a drug they were not supposed to take), duration error, dosing error, frequency error, route error, and timing error. We will record all drug errors identified.	30 days post randomization
Secondary	Medication error correction	Any medication error that is corrected.	30 days post randomization
Secondary	Surgical site infection	Surgical site infection is an infection that occurs within 30 days after randomization and involves the skin, subcutaneous tissue of the incision (superficial incisional), or the deep soft tissue (e.g., fascia, muscle) of the incision (deep incisional).	30 days post randomization
Secondary	Days in hospital	Days in hospital	30 days post randomization
Secondary	Level of pain and pain related interference in recovery	Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).4 The BPI-SF includes four 11-point numeric rating scales (NRS) of pain intensity, which measure "average", "least", and "worst" pain intensity in the past 24 hours (hrs.), respectively, as well as pain intensity "now" (0= no pain, 10= pain as bad as you can imagine). The BPI-SF interference subscale will also be used, which measures the degree to which pain interferes with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life (NRS for each item; 0=does not interfere, 10=completely interferes). A total interference score is determined by calculating the sum of these 7 items. The BPI-SF has strong psychometric properties with well-established reliability and validity across divergent surgical groups. Moderate to severe pain is defined by a score of =4/10 on a standard numeric rating scale (NRS) for pain.	15 and 30 days post randomization
Secondary	Optimization of medications for long-term health	Among patients with atherosclerotic disease, we will also assess optimal pharmacological management based upon whether patients are taking 0, 1, 2, or 3 of the following classes of efficacious medications at 30 days (i.e., an antiplatelet or anticoagulant drug; an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker; and a statin). Among active smokers before surgery we will assess if patients are receiving pharmacological smoking cessation interventions at 30 days after randomization.	30 days post randomization