Clinical trial NCT05171569: Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology-3 Trial
Official title: Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology-3 (PVC-RAM-3) Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgery
Keywords: Virtual care
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2021-12-29
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 and use of acute hospital care (composite of hospital readmission and emergency department visit) after randomization, in adults who have undergone elective non cardiac surgery. Secondary outcomes at 30 days after randomization include: 1) hospital re-admission; 2) emergency department visit; 3) medication error detection;4) medication error correction; 5) surgical site infection; and 6) 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Index hospital length of stay
timeFrame: 30 Days post randomization
measure: Acute hospital care (composite of hospital readmission and emergency department visit)
timeFrame: 30 Days post randomization
Secondary outcomes:
measure: Hospital readmission
timeFrame: 30 days post randomization
measure: Emergency department visit (includes urgent care centre visit)
timeFrame: 30 days post randomization
measure: Medication error detection
timeFrame: 30 days post randomization
measure: Medication error correction
timeFrame: 30 days post randomization
measure: Surgical site infection
timeFrame: 30 days post randomization
measure: Days in hospital
timeFrame: 30 days post randomization
measure: Level of pain and pain related interference in recovery
timeFrame: 15 and 30 days post randomization
measure: Optimization of medications for long-term health
timeFrame: 30 days post randomization
Other outcomes:
measure: Infection
timeFrame: 30 days post randomization
measure: Re-operation
timeFrame: 30 days post randomization
measure: Composite of myocardial infarction, acute heart failure, and arrhythmia that results in acute hospital care
timeFrame: 30 days post randomization
measure: Death
timeFrame: 30 days post randomization
measure: Health related quality of life (HRQoL)
timeFrame: 30 days post randomization
measure: Health services utilization-related costs
timeFrame: 30 days post randomization
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
Study officials:
affiliation: McMaster University, Population Health Research Institute
name: Michael McGillion, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University, Population Health Research Institute
name: PJ Devereaux, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References: