Post Op Home Monitoring After Joint Replacements

NCT02143232 | Completed DMC

• 1 other identifier: 20130412-01H
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Replacement; Total Hip Replacement

Keywords

knee replacement; hip replacement; patient monitor

Outcome Measures

Primary Outcomes (1)

• Successful transmission of ≥ 90% of patients' assessments from the patient station to the clinical station using the remote monitoring system.

  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. .

  Home Monitoring followup after hospital discharge for 4 days, 4 times during the day and as needed.

Secondary Outcomes (1)

• Difference in the incidence of unplanned readmissions or unplanned visits to the ED compared to 54 patients from a historical cohort 2010 - 2011 matched in age, sex, and procedures

  The cohort selected will be from 2010 to 2011. (up to 1 year)

Study Arms (1)

Remote patient monitoring (Telus RPM)

EXPERIMENTAL

The remote monitoring device (Telus RPM) is used by every patient in the study post operatively at home.

Device: remote patient monitoring (Telus RPM)

Interventions

remote patient monitoring (Telus RPM) DEVICE

All joint replacement patients in the study will use the same type of remote patient monitor for 4 days post operation at home.

Also known as: Telus RPM

Remote patient monitoring (Telus RPM)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective hip or knee arthroplasty
• Expected LOS ≤ 1 day
• Age 50 - 80 years
• Revised Cardiac Risk Index (RCRI) ≤ Class 2
• Available and able care-takers at home to assist the patient upon discharge during the early postoperative recovery phase.

You may not qualify if:

• ASA IV (American Association of Anesthesiology) classification
• COPD (chronic obstructive pulmonary disease) with FEV1 ≤ 1; (forced expiratory volume) OSA (obstructive sleep apnea)
• Patient or family reluctance to participate in early discharge
• Undiagnosed or on-going medical condition at time of discharge
• Previous participation in the study

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (3)

• Dervin GF, Madden SM, Crawford-Newton BA, Lane AT, Evans HC. Outpatient unicompartment knee arthroplasty with indwelling femoral nerve catheter. J Arthroplasty. 2012 Jun;27(6):1159-65.e1. doi: 10.1016/j.arth.2012.01.009. Epub 2012 Mar 28.

  PMID: 22459126 BACKGROUND

• Yang H, Dervin G, Madden S, Fayad A, Beaule P, Gagne S, Crossan ML, Wheeler K, Afagh M, Zhang T, Taljaard M. Postoperative Home Monitoring After Joint Replacement: Retrospective Outcome Study Comparing Cases With Matched Historical Controls. JMIR Perioper Med. 2018 Nov 5;1(2):e10169. doi: 10.2196/10169.

  PMID: 33401365 DERIVED

• Yang H, Dervin G, Madden S, Beaule PE, Gagne S, Crossan ML, Fayad A, Wheeler K, Afagh M, Zhang T, Taljaard M. Postoperative Home Monitoring After Joint Replacement: Feasibility Study. JMIR Perioper Med. 2018 Sep 5;1(2):e10168. doi: 10.2196/10168.

  PMID: 33401364 DERIVED

Study Officials

• Homer Yang, MD

  Clinical Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 21, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

CA (1)