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

Surgery Clinical Trial

— PVC-RAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04344665
• Other study ID #: v5.0, 2020.09.12
• Status: Completed
• Phase: N/A
• Start date: April 23, 2020
• Est. completion date: June 2, 2021

Study information

• Verified date: February 2024
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM) 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 days alive at home 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. It will also determine, during the first 30 days, the effect of virtual care with RAM technology on several secondary outcomes, including: 1. hospital re-admission; 2. emergency department visit; 3. urgent-care centre visit; 4. acute-hospital care (i.e., a composite of hospital re-admission and emergency department or urgent-care centre visit) 5. brief acute-hospital care (i.e., acute-hospital care that lasts <24 hours); 6. all-cause hospital days; 7. medication error detection; 8. medication error correction; and 9. death. An additional secondary objective is to determine the effect of virtual care with RAM technology on pain at 7, 15, and 30 days and 6 months after randomization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 905
• Est. completion date: June 2, 2021
• Est. primary completion date: October 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. are =40 years of age;

2. have undergone same-day or inpatient semi-urgent, urgent, or emergency surgery and are being discharged home or are within 24 hours after discharge home, as long as they have not had acute-hospital care since their discharge; and

3. provide informed consent to participate.

Exclusion Criteria:

1. underwent same-day surgery and the surgeon or anesthesiologist believe the case reflects a traditional same-day surgery case with a low likelihood of needing acute-hospital care;

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

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

4. reside in an area without cellular network coverage and no home Wi-Fi.

Related Conditions & MeSH terms

• COVID
• Perioperative Complication
• Surgery

Intervention

Other:
• Virtual Care and Remote Automated Monitoring
Patients will measure daily vitals (blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, weight) with remote monitoring technology and complete recovery surveys daily in home after discharge from hospital. Patients will interact with a virtual nurse daily on days 1-15 and every other day from days 16-30. If the patient's RAM measurements exceed predetermined thresholds, the patient reports specific symptoms (e.g., shortness of breath), a drug error is identified, or the virtual nurse has concerns about the patient's health that they cannot resolve, the virtual nurse will escalate care to a pre-assigned and available physician. Physicians will add or modify treatments as needed, and if required, they will have the patient come to an outpatient facility for evaluation or management. Via secure video or text messaging, patients will also have access to a virtual nurse at night, for any urgent issues.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton General Hospital	Hamilton
Canada	Juravinski Hospital	Hamilton
Canada	St. Joseph's Healthcare Hamilton	Hamilton
Canada	Kingston Health Sciences Centre	Kingston
Canada	London Health Sciences Centre	London
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Population Health Research Institute	Hamilton Health Sciences Corporation, McMaster University

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	30 Days (after randomization); 6 months (after randomization)
Other	Patient level cost of recovery	Assessment performed using the Ambulatory Home Care Record	30 Days (after randomization)
Other	Re-operation	Any surgical procedure undertaken for any reason (e.g., wound dehiscence, infection)	30 Days (after randomization); 6 months (after randomization)
Other	Arrythmia resulting in electrical cardioversion	Arrythmia resulting in electrical cardioversion	30 Days (after randomization); 6 months (after randomization)
Other	Acute renal failure resulting in dialysis	Acute renal failure resulting in dialysis	30 Days (after randomization); 6 months (after randomization)
Other	Respiratory failure	Patient intubated or put on bilevel positive airway pressure (BiPAP).	30 Days (after randomization); 6 months (after randomization)
Other	Infection	Infection	30 Days (after randomization); 6 months (after randomization)
Other	Surgical site infection		30 Days (after randomization); 6 months (after randomization)
Other	Life-threatening bleed		30 Days (after randomization); 6 months (after randomization)
Other	Major bleed		30 Days (after randomization); 6 months (after randomization)
Other	Critical organ bleed		30 Days (after randomization); 6 months (after randomization)
Other	Ileus		30 Days (after randomization); 6 months (after randomization)
Other	Myocardial Infarction		30 Days (after randomization); 6 months (after randomization)
Other	Clinically important atrial fibrillation		30 Days (after randomization); 6 months (after randomization)
Other	Symptomatic proximal venous thrombo-embolism		30 Days (after randomization); 6 months (after randomization)
Other	Stroke		30 Days (after randomization); 6 months (after randomization)
Other	Non-fatal cardiac arrest		30 Days (after randomization); 6 months (after randomization)
Other	Clostridium difficile-associated diarrhea		30 Days (after randomization); 6 months (after randomization)
Other	Indwelling device		30 Days (after randomization); 6 months (after randomization)
Other	COVID-19 Infection		30 Days (after randomization); 6 months (after randomization)
Other	Delirium	Positive history of delirium in hospital health records, positive 3D-CAM assessment, or FAM-CAM assessment. Assessments performed by telephone or in person.	30 Days (after randomization); 6 months (after randomization)
Other	Surgeon, family physician, or specialist in-person clinic visit		30 Days (after randomization); 6 months (after randomization)
Other	Sepsis		30 Days (after randomization); 6 months (after randomization)
Other	Acute Heart Failure		30 Days (after randomization); 6 months (after randomization)
Other	Surgeon, family physician, or specialist virtual visit		30 Days (after randomization); 6 months (after randomization)
Primary	Days alive at home	Days alive at home are the number of days patients spend at their usual residence - be it a house or apartment, a group home or shelter, a seniors residence, or a nursing home - or at a community residence of a relative, friend, or acquaintance without, during that day, being admitted to a hospital or visiting an emergency department or urgent-care centre. Thus, patients lose days alive at home if 1. patients go to an emergency department or urgent-care centre; 2. they become inpatients at a hospital or rehabilitation or convalescence-care facility; or 3. they die.	30 Days (after randomization); 6 months (after randomization)
Secondary	Hospital re-admission		30 Days (after randomization); 6 months (after randomization)
Secondary	Emergency Department visit		30 Days (after randomization); 6 months (after randomization)
Secondary	Urgent Care centre visit		30 Days (after randomization); 6 months (after randomization)
Secondary	Brief acute hospital care		30 Days (after randomization); 6 months (after 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.	Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31)
Secondary	Medication error correction	Any medication error that is corrected.	Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31)
Secondary	Death	All cause mortality	30 Days (after randomization); 6 months (after randomization)
Secondary	Participant Pain	Assessed using the Brief Pain Inventory Short Form (BPI-SF)	7 Days (after randomization); 15 Days (after randomization); 30 Days (after randomization); 6 months (after randomization)
Secondary	Acute hospital care	Composite of hospital re-admission and emergency department or urgent-care centre visit	30 Days (after randomization); 6 months (after randomization)
Secondary	All-cause hospital days	If a patient is admitted to the hospital for any reason anytime between midnight and 23:59 on a given day, this will count as a day in hospital.	30 Days (after randomization); 6 months (after randomization)