Post-Operative in-PatientsNCT00261157
Use of Robotic Telerounding After Operative Procedures
A study testing InTouch Telerounding Robot in people with Post-Operative in-Patients, run by University of California, Davis at 1 site in United States.
Trial summary
This research is being done to test a two-way video system mounted on top of a robot. After surgery the act of seeing and evaluating patients in the hospital is called standard "rounding". Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Post-Operative in-Patients
- What is being tested?
- InTouch Telerounding Robot
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Jun 2005
- 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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Patients, both men and women, undergoing a minimally invasive surgery at the UC Davis Medical Center who are over the age of 18 will be selected. Patients must have an expected hospital stay of greater than 24 hours but less than 72 hours.
Exclusion Criteria: Patients whose anticipated hospital stay exceeds 72 hours will not be included in this study.
-
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
Official title: Use of Robotic Telerounding After Operative Procedures: Does It Affect Patient Outcomes?
This research is being done to test a two-way video system mounted on top of a robot. After surgery the act of seeing and evaluating patients in the hospital is called standard "rounding". This research study will allow doctors to see and speak with their patients using the two-way video system - "telerounding", during their stay at the hospital. The purpose of this study is to assess the safety of telerounding during a patients hospital stay.
Our hypothesis is that post-operative morbidity and the time to identification of post-operative morbidity will not vary with this new method of rounding.
Read the detailed description
The Department of Urology and the University of California, Davis has made a major commitment to the development of novel applications of advanced telecommunications to the practice of modern health care.
Telemedicine has become an increasingly important although underutilized component of modern healthcare. To date, telemedicine has been limited to physician education in the form of video conferencing for seminars, and to providing specialist consultation in rural medical clinics. However, given the recent technological advances in wireless Internet capabilities and the decreasing cost of these services, we see alternate capabilities for this technology.
As is well known, the act of seeing patients at the bedside while they are hospitalized is called "rounding." For patients that have undergone an elective minimally invasive surgical procedure, such as laparoscopy, hospital stays have become brief events. In fact, the convalescence from these procedures is measured in days rather than weeks. For most individuals, the hospitalization is necessary to allow for the delivery of IV fluids, to check serum chemistries and blood counts while waiting for bowel function to return. To this end, the physician bedside visit is in large part an opportunity to relay information regarding the progress of recovery based on objective laboratory and vital sign measures.
We have developed a video-conferencing system that allows physicians to see and speak with their patients from a remote location (telerounding). In a randomized trial of telerounds versus standard rounds conducted while I was a Urology Fellow at Johns Hopkins, we examined the impact of this form of post-operative management on elements of patient satisfaction with their hospitalization. We found that patients managed with the telerounding system gave higher ratings for their hospitalization than those managed by standard bedside rounds. One such application is the use of teleconferencing as a primary mode of post-operative care management (telerounding). In a prior study we performed at Johns Hopkins, patients expressed higher ratings of satisfaction when the telerounding system was added to usual post-operative care. However, that project was not designed to address the issue of patient safety.
The purpose of the study is to assess if there is a difference in patient outcomes when post-operative patients are managed with "standard rounding" versus "telerounding". Our primary outcome measure is time to recognition of post-operative morbidity. The telerounding system will consist of a wireless Internet-based videoconferencing device mounted on a remotely controlled service robot.
This study will be a prospective, randomized trial. The study population will consist of patients scheduled for laparoscopic radical prostatectomy for the treatment of prostate cancer.
Patients will undergo their scheduled surgery and receive the usual perioperative and immediate post-operative care delivered by the recovery room staff. Once transferred to the patient floor, intervention patients will communicate with their attending physician on a daily basis via the teleconferencing system. Intervention patients will not be seen at the bedside by their attending surgeon. The hospital and resident staff will provide routine daily bedside care. Patients may remove themselves from the study at any time by requesting a bedside visit by the attending physician. The intervention will conclude with either the hospital discharge or identification of a major post-operative morbidity. Intervention arm participants will then participate in a series of focus groups. These sessions will serve as the basis for a detailed qualitative analysis of patient perceptions of this technology and its role in future health care.
- Conditions
- Post-Operative in-Patients
- Being tested
- InTouch Telerounding Robot
- Keywords
- nephrectomy, Safety, Laparoscopy, telerounding, prostatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InTouch Telerounding RobotDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The expected rate of morbidity after a laparoscopic urologic procedure is 16%. Two hundred eighty-four patients are required to detect a 1% difference in morbidity at a 0.05 alpha
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startApr 2004
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative in-PatientsStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Investigators
- Lars Ellison, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261157
- Sponsor's protocol ID
- 200412323-1
- Status last verified
- Nov 2005
- First submitted
- 30 Nov 2005
- Last updated
- 2 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Robotic Telerounding After Operative Procedures: Does It Affect Patient Outcomes?
- ClinicalTrials.gov ID
- NCT00261157
- Acronym / sponsor ID
- 200412323-1
- Conditions
- Post-Operative in-Patients
- Keywords
- nephrectomy, Safety, Laparoscopy, telerounding, prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Jun 2005
- First posted
- 2 Dec 2005 (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.
This research is being done to test a two-way video system mounted on top of a robot. After surgery the act of seeing and evaluating patients in the hospital is called standard "rounding". This research study will allow doctors to see and speak with their patients using the two-way video system - "telerounding", during their stay at the hospital. The purpose of this study is to assess the safety of telerounding during a patients hospital stay.
Our hypothesis is that post-operative morbidity and the time to identification of post-operative morbidity will not vary with this new method of rounding.
Detailed description
The Department of Urology and the University of California, Davis has made a major commitment to the development of novel applications of advanced telecommunications to the practice of modern health care.
Telemedicine has become an increasingly important although underutilized component of modern healthcare. To date, telemedicine has been limited to physician education in the form of video conferencing for seminars, and to providing specialist consultation in rural medical clinics. However, given the recent technological advances in wireless Internet capabilities and the decreasing cost of these services, we see alternate capabilities for this technology.
As is well known, the act of seeing patients at the bedside while they are hospitalized is called "rounding." For patients that have undergone an elective minimally invasive surgical procedure, such as laparoscopy, hospital stays have become brief events. In fact, the convalescence from these procedures is measured in days rather than weeks. For most individuals, the hospitalization is necessary to allow for the delivery of IV fluids, to check serum chemistries and blood counts while waiting for bowel function to return. To this end, the physician bedside visit is in large part an opportunity to relay information regarding the progress of recovery based on objective laboratory and vital sign measures.
We have developed a video-conferencing system that allows physicians to see and speak with their patients from a remote location (telerounding). In a randomized trial of telerounds versus standard rounds conducted while I was a Urology Fellow at Johns Hopkins, we examined the impact of this form of post-operative management on elements of patient satisfaction with their hospitalization. We found that patients managed with the telerounding system gave higher ratings for their hospitalization than those managed by standard bedside rounds. One such application is the use of teleconferencing as a primary mode of post-operative care management (telerounding). In a prior study we performed at Johns Hopkins, patients expressed higher ratings of satisfaction when the telerounding system was added to usual post-operative care. However, that project was not designed to address the issue of patient safety.
The purpose of the study is to assess if there is a difference in patient outcomes when post-operative patients are managed with "standard rounding" versus "telerounding". Our primary outcome measure is time to recognition of post-operative morbidity. The telerounding system will consist of a wireless Internet-based videoconferencing device mounted on a remotely controlled service robot.
This study will be a prospective, randomized trial. The study population will consist of patients scheduled for laparoscopic radical prostatectomy for the treatment of prostate cancer.
Patients will undergo their scheduled surgery and receive the usual perioperative and immediate post-operative care delivered by the recovery room staff. Once transferred to the patient floor, intervention patients will communicate with their attending physician on a daily basis via the teleconferencing system. Intervention patients will not be seen at the bedside by their attending surgeon. The hospital and resident staff will provide routine daily bedside care. Patients may remove themselves from the study at any time by requesting a bedside visit by the attending physician. The intervention will conclude with either the hospital discharge or identification of a major post-operative morbidity. Intervention arm participants will then participate in a series of focus groups. These sessions will serve as the basis for a detailed qualitative analysis of patient perceptions of this technology and its role in future health care.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| InTouch Telerounding Robot | Device | – |
Primary outcome
The expected rate of morbidity after a laparoscopic urologic procedure is 16%. Two hundred eighty-four patients are required to detect a 1% difference in morbidity at a 0.05 alpha
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 2 Dec 2005.
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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.
Lars Ellison, M.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InTouch Telerounding Robot in people with Post-Operative in-Patients, run by University of California, Davis 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?
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 2 Dec 2005. 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?
The expected rate of morbidity after a laparoscopic urologic procedure is 16%. Two hundred eighty-four patients are required to detect a 1% difference in morbidity at a 0.05 alpha. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2005.