Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00261157 |
| Other study ID # |
200412323-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
November 30, 2005 |
| Last updated |
November 30, 2005 |
| Start date |
April 2004 |
| Est. completion date |
June 2005 |
Study information
| Verified date |
November 2005 |
| Source |
University of California, Davis |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Food and Drug Administration |
| Study type |
Interventional
|
Clinical 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". 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.
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.
