UrologyNCT02771431
The Use of Videoconferencing for Monitoring of Patients Post Urologic Surgery
A study testing Tele-rounding in post operative care in people with Urology, run by Northwell Health at 1 site in United States.
Trial summary
Our study would be the first randomized study investigating the use of video conferencing via tablet computers versus traditional bedside rounding and its effect on clinical data such as length of stay and complications as well as patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urology
- What is being tested?
- Tele-rounding in post operative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 13 Nov 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older
- Undergo elective Urologic surgery requiring post-operative inpatient stay
Who cannot join
- Patients under 18 years of age
- Patients who are unable to provide their own consent
- Patients who undergo urgent or emergent Urologic procedures who are not already enrolled in the study
- Patients who do not require an inpatient post-operative stay
- Patients who are seen on the weekend (Saturday or Sunday)
Trial locations and contacts
1 site in 1 country.
About this study
Our study would be the first randomized study investigating the use of video conferencing via tablet computers versus traditional bedside rounding and its effect on clinical data such as length of stay and complications as well as patient satisfaction. As technology improves, medicine has an obligation to incorporate this technology to improve efficiency and cost-effectiveness. If telerounding is proven to not change outcomes or patient satisfaction, it saves time for the physician during office hours to see more patients or be productive in other ways. Telerounding could be applied in remote areas with a dearth of specialists, allowing these specialists' expertise to reach areas it could not before.
Read the detailed description
As the healthcare system in America is evolving, doctors are becoming hard-pressed to see and treat more patients in the same amount of time. Over the past century, different forms of "telemedicine" have allowed doctors to treat patients from a distance, in hopes of increasing access to medical care. Several studies have evaluated the utility of telemedicine in the ICU setting, namely using video-conferencing technology to allow ICU attending physicians to monitor their patients with audio and video media more closely. A prospective, step-wedge study by Lily showed that the use of telemedicine reduced adjusted odds mortality and length of stay in the ICU, as well as several complications such as stress ulcers, deep venous thromboses, and ventilator associated pneumonia. Similar conclusions were found by a meta-analysis in 2011 that looked at 176 tele-ICU articles, which included 41,374 patients. With telemedicine technology, intensivists can theoretically have 24-hour oversight of the ICU from a remote location, possibly being able to oversee multiple units.
Although the average urology patient does not require as frequent monitoring as the ICU patient, telemedicine may still play a role in facilitating care for the postoperative urologic patient. In 2004, Ellison el al conducted a study comparing patient satisfaction between patients seen via standard bedside rounds, patients seen via telerounds (as an additional visit) through a laptop computer, and patients only seen via telerounds through a remotely controlled robot. This study showed that telerounding (either of the latter two arms) was associated with greater patient satisfaction in postoperative care, which was found to be linked to physician availability4. In 2007, the same authors conducted a randomized study investigating morbidity, length of stay, and patient satisfaction between standard bedside rounds versus robotic telerounding. There were no differences in outcomes between the two groups. A significant limitation of robotic telerounding is cost. Having and maintaining the robot costs around $60,000 per year, although Gandas et al was able to find a positive financial impact when using the robot in postoperative gastric bypass patients6. However, the development of tablet computers, which have user-friendly video-conferencing applications, has made telemedicine a more affordable tool. In 2012, Kacsmarek et al conducted the first study using tablet computers investigating post-operative patient satisfaction. Their study demonstrated that tablet telerounding can significantly enhance patients' post-operative experience by providing quicker face-to-face access with their attending physician.
Our study would be the first randomized study investigating the use of video conferencing via tablet computers versus traditional bedside rounding and its effect on clinical data such as length of stay and complications as well as patient satisfaction. As technology improves, medicine has an obligation to incorporate this technology to improve efficiency and cost-effectiveness. If telerounding is proven to not change outcomes or patient satisfaction, it saves time for the physician during office hours to see more patients or be productive in other ways. Telerounding could be applied in remote areas with a dearth of specialists, allowing these specialists' expertise to reach areas it could not before.
- Conditions
- Urology
- Being tested
- Tele-rounding in post operative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-rounding in post operative careOther
Both groups will receive standard of care. The only difference between these groups would be the physical presence of the attending in the room. Both groups will receive a physical exam with supervision of the attending, one group will have attending in the room and the other will have the attending present via I-pad. In both cases if there was something of concern the attending would step in for the physical exam if needed, regardless of which group they were randomized for.
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Group 1 will consist of patients receiving in-person attending-patient encounters while inpatients. |
| Tele-rounding | Experimental | Group 2 will consist of patients receiving video-conference attending-patient encounters. The intervention is being seen via ipad Receives: Other: Tele-rounding in post operative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rates
Measured: 4 years
length of inpatient stay
Measured: 4 years
number of lab tests ordered
Measured: 4 years
severity of complications
Measured: 4 years
Secondary outcomes (1)
Additionally patient satisfaction will be looked at based on post-operative questionnaire.
how satisfied they were with seeing provider remotely vs standard of care
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startFeb 2015
- Primary completion13 Nov 2018
- Study completion13 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for UrologyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manish Vira, Northwell Health
- Investigators
- Manish Vira, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771431
- Sponsor's protocol ID
- 14-659
- Status last verified
- Aug 2019
- First submitted
- 22 Feb 2016
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Strehle EM, Shabde N. One hundred years of telemedicine: does this new technology have a place in paediatrics? Arch Dis Child. 2006 Dec;91(12):956-9. doi: 10.1136/adc.2006.099622.
PubMed 17119071Lilly CM, Cody S, Zhao H, Landry K, Baker SP, McIlwaine J, Chandler MW, Irwin RS; University of Massachusetts Memorial Critical Care Operations Group. Hospital mortality, length of stay, and preventable complications among critically ill patients before and after tele-ICU reengineering of critical care processes. JAMA. 2011 Jun 1;305(21):2175-83. doi: 10.1001/jama.2011.697. Epub 2011 May 16.
PubMed 21576622Young LB, Chan PS, Lu X, Nallamothu BK, Sasson C, Cram PM. Impact of telemedicine intensive care unit coverage on patient outcomes: a systematic review and meta-analysis. Arch Intern Med. 2011 Mar 28;171(6):498-506. doi: 10.1001/archinternmed.2011.61.
PubMed 21444842Ellison LM, Pinto PA, Kim F, Ong AM, Patriciu A, Stoianovici D, Rubin H, Jarrett T, Kavoussi LR. Telerounding and patient satisfaction after surgery. J Am Coll Surg. 2004 Oct;199(4):523-30. doi: 10.1016/j.jamcollsurg.2004.06.022.
PubMed 15454133Ellison LM, Nguyen M, Fabrizio MD, Soh A, Permpongkosol S, Kavoussi LR. Postoperative robotic telerounding: a multicenter randomized assessment of patient outcomes and satisfaction. Arch Surg. 2007 Dec;142(12):1177-81; discussion 1181. doi: 10.1001/archsurg.142.12.1177.
PubMed 18086984Gandsas A, Parekh M, Bleech MM, Tong DA. Robotic telepresence: profit analysis in reducing length of stay after laparoscopic gastric bypass. J Am Coll Surg. 2007 Jul;205(1):72-7. doi: 10.1016/j.jamcollsurg.2007.01.070.
PubMed 17617335Kaczmarek BF, Trinh QD, Menon M, Rogers CG. Tablet telerounding. Urology. 2012 Dec;80(6):1383-8. doi: 10.1016/j.urology.2012.06.060.
PubMed 23206790
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Videoconferencing for Monitoring of Patients Post Urologic Surgery
- ClinicalTrials.gov ID
- NCT02771431
- Acronym / sponsor ID
- 14-659
- Conditions
- Urology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 13 May 2016 (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.
Our study would be the first randomized study investigating the use of video conferencing via tablet computers versus traditional bedside rounding and its effect on clinical data such as length of stay and complications as well as patient satisfaction. As technology improves, medicine has an obligation to incorporate this technology to improve efficiency and cost-effectiveness. If telerounding is proven to not change outcomes or patient satisfaction, it saves time for the physician during office hours to see more patients or be productive in other ways. Telerounding could be applied in remote areas with a dearth of specialists, allowing these specialists' expertise to reach areas it could not before.
Detailed description
As the healthcare system in America is evolving, doctors are becoming hard-pressed to see and treat more patients in the same amount of time. Over the past century, different forms of "telemedicine" have allowed doctors to treat patients from a distance, in hopes of increasing access to medical care. Several studies have evaluated the utility of telemedicine in the ICU setting, namely using video-conferencing technology to allow ICU attending physicians to monitor their patients with audio and video media more closely. A prospective, step-wedge study by Lily showed that the use of telemedicine reduced adjusted odds mortality and length of stay in the ICU, as well as several complications such as stress ulcers, deep venous thromboses, and ventilator associated pneumonia. Similar conclusions were found by a meta-analysis in 2011 that looked at 176 tele-ICU articles, which included 41,374 patients. With telemedicine technology, intensivists can theoretically have 24-hour oversight of the ICU from a remote location, possibly being able to oversee multiple units.
Although the average urology patient does not require as frequent monitoring as the ICU patient, telemedicine may still play a role in facilitating care for the postoperative urologic patient. In 2004, Ellison el al conducted a study comparing patient satisfaction between patients seen via standard bedside rounds, patients seen via telerounds (as an additional visit) through a laptop computer, and patients only seen via telerounds through a remotely controlled robot. This study showed that telerounding (either of the latter two arms) was associated with greater patient satisfaction in postoperative care, which was found to be linked to physician availability4. In 2007, the same authors conducted a randomized study investigating morbidity, length of stay, and patient satisfaction between standard bedside rounds versus robotic telerounding. There were no differences in outcomes between the two groups. A significant limitation of robotic telerounding is cost. Having and maintaining the robot costs around $60,000 per year, although Gandas et al was able to find a positive financial impact when using the robot in postoperative gastric bypass patients6. However, the development of tablet computers, which have user-friendly video-conferencing applications, has made telemedicine a more affordable tool. In 2012, Kacsmarek et al conducted the first study using tablet computers investigating post-operative patient satisfaction. Their study demonstrated that tablet telerounding can significantly enhance patients' post-operative experience by providing quicker face-to-face access with their attending physician.
Our study would be the first randomized study investigating the use of video conferencing via tablet computers versus traditional bedside rounding and its effect on clinical data such as length of stay and complications as well as patient satisfaction. As technology improves, medicine has an obligation to incorporate this technology to improve efficiency and cost-effectiveness. If telerounding is proven to not change outcomes or patient satisfaction, it saves time for the physician during office hours to see more patients or be productive in other ways. Telerounding could be applied in remote areas with a dearth of specialists, allowing these specialists' expertise to reach areas it could not before.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Group 1 will consist of patients receiving in-person attending-patient encounters while inpatients. |
| Tele-rounding | Experimental | Other: Tele-rounding in post operative careGroup 2 will consist of patients receiving video-conference attending-patient encounters. The intervention is being seen via ipad |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years of age or older
- Undergo elective Urologic surgery requiring post-operative inpatient stay
Key exclusion criteria (5 listed)
- Patients under 18 years of age
- Patients who are unable to provide their own consent
- Patients who undergo urgent or emergent Urologic procedures who are not already enrolled in the study
- Patients who do not require an inpatient post-operative stay
- Patients who are seen on the weekend (Saturday or Sunday)
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 |
|---|---|---|
| Tele-rounding in post operative careBoth groups will receive standard of care. The only difference between these groups would be the physical presence of the attending in the room. Both groups will receive a physical exam with supervision of the attending, one group will have attending in the room and the other will have the attending present via I-pad. In both cases if there was something of concern the attending would step in for the physical exam if needed, regardless of which group they were randomized for. | Other | Tele-rounding |
Primary outcome
Complication rates
Time frame: 4 years
length of inpatient stay
Time frame: 4 years
number of lab tests ordered
Time frame: 4 years
severity of complications
Time frame: 4 years
1 secondary outcome
Additionally patient satisfaction will be looked at based on post-operative questionnaire.
Time frame: 4 years
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 8 Aug 2019.
- Background: PubMed 17119071Strehle EM, Shabde N. One hundred years of telemedicine: does this new technology have a place in paediatrics? Arch Dis Child. 2006 Dec;91(12):956-9. doi: 10.1136/adc.2006.099622.
- Background: PubMed 21576622Lilly CM, Cody S, Zhao H, Landry K, Baker SP, McIlwaine J, Chandler MW, Irwin RS; University of Massachusetts Memorial Critical Care Operations Group. Hospital mortality, length of stay, and preventable complications among critically ill patients before and after tele-ICU reengineering of critical care processes. JAMA. 2011 Jun 1;305(21):2175-83. doi: 10.1001/jama.2011.697. Epub 2011 May 16.
- Background: PubMed 21444842Young LB, Chan PS, Lu X, Nallamothu BK, Sasson C, Cram PM. Impact of telemedicine intensive care unit coverage on patient outcomes: a systematic review and meta-analysis. Arch Intern Med. 2011 Mar 28;171(6):498-506. doi: 10.1001/archinternmed.2011.61.
- Background: PubMed 15454133Ellison LM, Pinto PA, Kim F, Ong AM, Patriciu A, Stoianovici D, Rubin H, Jarrett T, Kavoussi LR. Telerounding and patient satisfaction after surgery. J Am Coll Surg. 2004 Oct;199(4):523-30. doi: 10.1016/j.jamcollsurg.2004.06.022.
- Background: PubMed 18086984Ellison LM, Nguyen M, Fabrizio MD, Soh A, Permpongkosol S, Kavoussi LR. Postoperative robotic telerounding: a multicenter randomized assessment of patient outcomes and satisfaction. Arch Surg. 2007 Dec;142(12):1177-81; discussion 1181. doi: 10.1001/archsurg.142.12.1177.
- Background: PubMed 17617335Gandsas A, Parekh M, Bleech MM, Tong DA. Robotic telepresence: profit analysis in reducing length of stay after laparoscopic gastric bypass. J Am Coll Surg. 2007 Jul;205(1):72-7. doi: 10.1016/j.jamcollsurg.2007.01.070.
- Background: PubMed 23206790Kaczmarek BF, Trinh QD, Menon M, Rogers CG. Tablet telerounding. Urology. 2012 Dec;80(6):1383-8. doi: 10.1016/j.urology.2012.06.060.
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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.
Manish Vira, MD principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-rounding in post operative care in people with Urology, run by Northwell Health at 1 site in United States.
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 2 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 8 Aug 2019. 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 United States. 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?
Complication rates (time frame: 4 years). The study lists 4 primary outcomes in all. 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 NCT02771431, which also lists 7 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 8 Aug 2019.