Total Knee ReplacementPOHMNCT02143232
Post Op Home Monitoring After Joint Replacements
A study testing remote patient monitoring (Telus RPM) in people with Total Knee Replacement and Total Hip Replacement, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Replacement, Total Hip Replacement
- What is being tested?
- remote patient monitoring (Telus RPM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postop Home Monitoring After Joint Replacements (POHM)
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.
Read the detailed description
- Background and rationale. According to the latest Canadian Census, seniors aged 65 or over have increased in number by 609,810 from 13.7% of the population in 2006 to 4,945,060, or 14.8% in 2011. In Ontario, in 2001, there were 8,000 total hip replacements (THR) and 11,000 total knee replacements (TKR); in 2016, the projection is 20,000 THR and 54,000 TKR, assuming age-specific rates remain the same(1). At The Ottawa Hospital (TOH), we have already witnessed the pressure on bed management due to the increasing case volume. As a solution, we have successfully organized early discharges (EDc), on the same day, in select patients after unicompartment arthroplasty in order to reduce the length of stay (LOS)(2). Since then, we have discharged select major joint replacement patients on the same day or after overnight stay on multimodal analgesia. 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.
- Methods This is a feasibility study to allow planning for a larger future study to prove the above hypothesis.
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.
- Conditions
- Total Knee Replacement, Total Hip Replacement
- Being tested
- remote patient monitoring (Telus RPM)
- Keywords
- knee replacement, hip replacement, patient monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote patient monitoring (Telus RPM)Device
Also called Telus RPM
All joint replacement patients in the study will use the same type of remote patient monitor for 4 days post operation at home.
| Study group | Role | What they receive |
|---|---|---|
| Remote patient monitoring (Telus RPM) | Experimental | The remote monitoring device (Telus RPM) is used by every patient in the study post operatively at home. Receives: Device: remote patient monitoring (Telus RPM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
.
Measured: 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
Chart Review
Measured: The cohort selected will be from 2010 to 2011. (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Responsible party
- Sponsor
- Investigators
- Homer Yang, MD, Principal investigator, Clinical Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143232
- Sponsor's protocol ID
- 20130412-01H
- Acronym
- POHM
- Status last verified
- Apr 2018
- First submitted
- 12 May 2014
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 22459126Yang 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.
PubMed 33401365Yang 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.
PubMed 33401364
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postop Home Monitoring After Joint Replacements (POHM)
- ClinicalTrials.gov ID
- NCT02143232
- Acronym / sponsor ID
- POHM / 20130412-01H
- Conditions
- Total Knee Replacement, Total Hip Replacement
- Keywords
- knee replacement, hip replacement, patient monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Study start
- Apr 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Background and rationale. According to the latest Canadian Census, seniors aged 65 or over have increased in number by 609,810 from 13.7% of the population in 2006 to 4,945,060, or 14.8% in 2011. In Ontario, in 2001, there were 8,000 total hip replacements (THR) and 11,000 total knee replacements (TKR); in 2016, the projection is 20,000 THR and 54,000 TKR, assuming age-specific rates remain the same(1). At The Ottawa Hospital (TOH), we have already witnessed the pressure on bed management due to the increasing case volume. As a solution, we have successfully organized early discharges (EDc), on the same day, in select patients after unicompartment arthroplasty in order to reduce the length of stay (LOS)(2). Since then, we have discharged select major joint replacement patients on the same day or after overnight stay on multimodal analgesia. 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.
- Methods This is a feasibility study to allow planning for a larger future study to prove the above hypothesis.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote patient monitoring (Telus RPM) | Experimental | Device: remote patient monitoring (Telus RPM)The remote monitoring device (Telus RPM) is used by every patient in the study post operatively at home. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote patient monitoring (Telus RPM)Also: Telus RPMAll joint replacement patients in the study will use the same type of remote patient monitor for 4 days post operation at home. | Device | Remote patient monitoring (Telus RPM) |
Primary outcome
Successful transmission of ≥ 90% of patients' assessments from the patient station to the clinical station using the remote monitoring system.
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. .
1 secondary outcome
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
Time frame: The cohort selected will be from 2010 to 2011. (up to 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Background: PubMed 22459126Dervin 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.
- Derived from this study: PubMed 33401365Yang 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.
- Derived from this study: PubMed 33401364Yang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Homer Yang, MD principal investigator
Clinical Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote patient monitoring (Telus RPM) in people with Total Knee Replacement and Total Hip Replacement, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful transmission of ≥ 90% of patients' assessments from the patient station to the clinical station using the remote monitoring system. (time frame: Home Monitoring followup after hospital discharge for 4 days, 4 times during the day and as needed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02143232, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.