Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) -2 Trial

Surgery Clinical Trial

— PVC-RAM-2  

Official title:

Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM)-2 Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04876950
• Other study ID #: 1.0.2021.04.30
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: March 2026

Study information

• Verified date: July 2023
• Source: Population Health Research Institute
• Contact: Valerie Harvey
• Phone: 905-527-4322
• Email: valerie.harvey[@]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)-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 30-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 30 days after randomization include 1) hospital re-admission; 2) emergency department visit; 3) medication error detection; 4) medication error correction; and 5) surgical site infection. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 7, 15, and 30 days. We will also assess optimal management of long-term health by evaluating among patients with atherosclerotic disease whether patients are taking classes of efficacious medications at 30 days.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: March 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. are =40 years of age;

2. have undergone inpatient semi-urgent, urgent, or emergency surgery and the most responsible physician has decided to discharge the patient;

3. are on the day of being discharged home or are within 24 hours after discharge home without having obtained acute hospital care since discharge; and

4. provide informed consent to participate.

Exclusion Criteria:

1. went to rehabilitation or convalescent care for more than 7 days after undergoing surgery;

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

3. reside in an area without cellular network coverage.

Related Conditions & MeSH terms

• Perioperative Complication
• Surgery

Intervention

Combination Product:
• Virtual care with remote automated monitoring
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
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health services utilization-related costs	Data on hospital re-admission, healthcare utilization, and costs of health service utilization will be obtained from the Institute for Clinical Evaluative Sciences (ICES) data repository. Administrative databases used to describe the health service utilization include: 1. Registered Persons Database (RPDB) - demographics and vital statistics of all legal residents of Ontario; 2. Discharge Abstract Database - records of inpatient hospitalizations from the Canadian Institute for Health Information (CIHI); 3. Ontario Health Insurance Plan (OHIP) Database - physician billing claims, and the National Ambulatory Care Reporting System - information on emergency department visits from CIHI.	30 days post randomization
Other	Patient-level cost of recovery	The Ambulatory and Home Care Record (AHCR) will be used to comprehensively measure patient-level costs of illness from a societal perspective. This approach gives equal consideration to health system costs and costs borne by patients and unpaid caregivers (e.g., family members, friends). AHCR items can be categorized as publicly financed (e.g., public sector paid resources) or privately financed care (e.g., all out-of-pocket and third-party insurance payments, and time costs incurred by caregiver). Face validity and reliability of the AHCR is well established in multiple groups, including surgical patients.	30 days post randomization
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) that is related to the index surgery.	30 days post randomization
Other	composite of myocardial infarction, acute heart failure, arrhythmia that results in patient presenting to an emergency department/urgent care centre or being admitted to hospital.	Myocardial infarction: 4th Universal definition of myocardial infarction.; Acute Heart Failure: 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.; Arrhythmia that results in patient presenting to an emergency department/urgent care centre or being admitted to hospital: Any Arrhythmia that results in patient presenting to an emergency department/urgent care centre or being admitted to hospital.	30 days post randomization
Other	Death	All cause mortality.	30 days post randomization
Other	COVID Infection	Any laboratory confirmed evidence of COVID-19 infection.	30 days post randomization
Other	surgeon, family physician, or specialist in-person visit	Patient has a in-person clinical visit with a surgeon, family physician, or specialist.	30 days post randomization
Other	surgeon, family physician, or specialist virtual clinic visit	Patient has a virtual clinical visit with a surgeon, family physician, or specialist.	30 days post randomization
Other	moderate-to-severe persistent post-surgical pain	Persistent post-surgical pain at has been adopted by the proposed classification for chronic post-surgical pain established by the International Association for the Study of Pain (IASP). A patient will meet the primary outcome if: 1) the patient reports non-zero pain (NRS pain score >0 at rest) in the last 24-hours, 2) located around the surgical incision (i.e., axilla, medial arm, shoulder, or chest wall on the side of surgery), 3) at 3-months after surgery (IASP's time required for normal healing from injury), 4) with no other identifiable cause of pain (e.g., no pre-existing pain condition, infection, or malignancy). Pain is of moderate or greater severity is defined by a score of =4/10 on a standard numeric rating scale (NRS) for pain.	6 months post randomization
Primary	Acute-hospital care	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	Patient visit to an emergency department.	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 and also report whether they resulted in harm.	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	Pain of any severity	Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).19 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).	7, 15, and 30 days post randomization
Secondary	Moderate to severe pain	Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).19 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). Pain is of moderate or greater severity is defined by a score of =4/10 on a standard numeric rating scale (NRS) for pain.	7, 15, and 30 days post randomization
Secondary	Optimal pharmacological management for patients with atherosclerotic disease	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).	30 days post randomization