Clinical trial NCT04876950: Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-2 (PVC-RAM-2) Trial
Official title: Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-2 (PVC-RAM-2) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Perioperative Complication
Keywords: Virtual care
Remote monitoring
Acute hospital care
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology-2 (PVC-RAM-2) 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 acute-hospital care during the 45-day follow up after randomization, in adults who have undergone semi-urgent (e.g., oncology), urgent (e.g., hip fracture), or emergency (e.g., ruptured abdominal aortic aneurysm) surgery. Secondary outcomes at 45 days after randomization include 1) days in hospital; 2) index length of hospital stay; 3) hospital re-admission; 4) emergency department visit; 5) medication error detection; 6) medication error correction; and 7) surgical site infection. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 15 and 45 days. We will also assess optimal management of long-term health by evaluating among self-reported current smokers and those with atherosclerotic disease, whether patients are taking classes of efficacious medications at 45 days post randomization.


Eligibility criteria: Inclusion Criteria:

1. are ≥40 years of age;
2. will undergo or have undergone semi-urgent, urgent, or emergency surgery requiring expected hospital stay of ≥2 days; and
3. provide informed consent to participate.

Exclusion Criteria:

1. planned transfer to a rehabilitation or convalescent facility, or repatriation from trial hospital site to local community hospital following surgery;
2. 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
3. reside in an area without cellular network coverage.

Primary outcomes:
measure: Acute-hospital care
timeFrame: 45 days post randomization
Secondary outcomes:
measure: Days in hospital
timeFrame: 45 days post randomization
measure: Index length of hospital stay
timeFrame: 45 days post randomization
measure: Hospital readmission
timeFrame: 45 days post randomization
measure: Emergency department visit
timeFrame: 45 days post randomization
measure: Medication error detection
timeFrame: 45 days post randomization
measure: Medication error correction
timeFrame: 45 days post randomization
measure: Surgical site infection
timeFrame: 45 days post randomization
measure: Pain of any severity
timeFrame: 15 and 45 days post randomization
measure: Moderate to severe pain
timeFrame: 15 and 45 days post randomization
measure: Optimal pharmacological management for patients with atherosclerotic disease
timeFrame: 45 days post randomization
measure: Optimal pharmacological management self-reported current smokers
timeFrame: 45 days post randomization
Other outcomes:
measure: Infection
timeFrame: 45 days post randomization
measure: Re-operation
timeFrame: 45 days post randomization
measure: Myocardial Infarction
timeFrame: 45 days post randomization
measure: Acute Heart Failure
timeFrame: 45 days post randomization
measure: Arrhythmia that results in patient presenting to an emergency department or being admitted to hospital
timeFrame: 45 days post randomization
measure: Death
timeFrame: 30 days post randomization
measure: Health-related quality of life (HRQL)
timeFrame: 45 days post randomization
measure: Health services utilization-related costs
timeFrame: 45 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
affiliation: Hamilton Health Sciences, Population Health Research Institute
name: Sandra Ofori, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: