The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9, Canada
NCT Number: NCT02143232
The investigators propose to deploy an interactive device to monitor the patient's recovery and vital signs at home after joint replacements. These will be early discharge patients on the same day or the next morning. The goal will be to support early discharges by creating a safe, controlled, and monitored environment at home.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Ottawa, Ontario, K1Y 4E9, Canada
A remote patient monitoring interactive system for chronic disease care. This monitor allows telephone or wireless connectivity with the patient and is equipped with NIBP (non-invasive blood pressure), HR (heart rate), and SpO2 (pulse oximetry) measurements that the patient or a caretaker could use at home. It generates regular reminders for the patient to measure his/her NIBP, HR, glucose levels if appropriate and SpO2 as well as answer a scripted questionnaire for pain. Results and alerts are then transmitted to the healthcare team. The system has never been deployed in an acute care or post-op environment. We propose therefore to conduct a feasibility study on early discharge patients after unicompartment or total joint replacements, deploying the Telus interactive RPM with our existing early discharge care path.
A sample size of 54 is sufficient to yield a one-sided 95% confidence interval estimate around our primary outcome measure (proportion of successful transmissions) with a lower bound exceeding the cutpoint for feasibility of 90%, assuming a proportion of 95% successful transmission. Recruitment will be at the orthopedic clinics, using the approved OHRI "Consent for Personal Health Information Review for Research Purposes" obtained through a member of the circle of care. Informed consent will be obtained at the General Pre-Admission Unit (PAU) by the research assistant after eligibility has been determined. A screening process for unicompartment knee arthroplasty and care path for same day discharge is currently in place. For this study, care paths for same day / early discharge for total hip and knee arthroplasty will be confirmed. Theses care paths will include home visits by nursing and physio through the Community Care Access Centre (CCAC).
Patients who satisfy the early discharge criteria will be approached. After informed consent the use of the remote patient monitoring device will be demonstrated . prior to discharge, after ensuring that the patient has achieved the defined outcomes of the care path, the functionalities of the device will be reviewed with the patient and care-taker. The patient will be given the monitor to bring home and set up. If required a member of the study team will assist you with the set up and use of the device This may require a home visit. CCAC visit will be as outlined in the care path and at the latest by the next day. Monitoring will be continued for 4 days at home.The system will be repatriated to TOH for cleaning and preventative maintenance.
Post-operative complications will be documented at Day 4 and with a followup phone call at 30 days, including POMI (postoperative myocardial infarction),CHF (congestive heart failure),DVT (deep vein thrombosis), PE (pulmonary embolism)pneumonia, cardiac dysrhythmia requiring treatment, wound dehiscence, and surgical site infections (SSI). The patient satisfaction questionnaire will include concerns with the RPM as well as the healthcare team response and will be completed by the patient using the patient monitoring system within 48 hours after the monitoring is completed.A followup phone call will occur at Day 30. Results from this feasibility study will be used to plan a future large-scale randomized controlled trial to evaluate effectiveness and safety of the above.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All joint replacement patients in the study will use the same type of remote patient monitor for 4 days post operation at home.
Other names: Telus RPM
Time frame: Home Monitoring followup after hospital discharge for 4 days, 4 times during the day and as needed.
The patient will do a measure of his/her blood pressure, heart rate,oxygen saturation, glucose levels (if appropriate) and pain assessment and this will be transmitted to a clinical station for observation by a clinical /medical person. Such a system is interactive, providing support to the patient at home, with reminders for medications, glucose control,blood pressure control, and a conduit to report problems such as pain and those associated with the surgical incision. Patients upon early discharge may also feel isolated, especially if there are questions on surgical and medical management issues or pain control. The alert system provides a safe and reliable communications channel for the patient.
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Time frame: The cohort selected will be from 2010 to 2011. (up to 1 year)
Chart Review
Ottawa Hospital Research Institute
Other
Postop Home Monitoring After Joint Replacements (POHM)
Acronym: POHM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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