The Use of Videoconferencing for Monitoring of Patients Post Urologic Surgery

August 6, 2019 updated by: Manish Vira, Northwell Health
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11042
        • North Shore LIJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients 18 years of age or older
  2. Undergo elective Urologic surgery requiring post-operative inpatient stay

Exclusion Criteria:

  1. Patients under 18 years of age
  2. Patients who are unable to provide their own consent
  3. Patients who undergo urgent or emergent Urologic procedures who are not already enrolled in the study
  4. Patients who do not require an inpatient post-operative stay
  5. Patients who are seen on the weekend (Saturday or Sunday)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard
Group 1 will consist of patients receiving in-person attending-patient encounters while inpatients.
Experimental: Tele-rounding
Group 2 will consist of patients receiving video-conference attending-patient encounters. The intervention is being seen via ipad
Other: Tele-rounding in post operative care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Complication rates
Time Frame: 4 years
4 years
length of inpatient stay
Time Frame: 4 years
4 years
number of lab tests ordered
Time Frame: 4 years
4 years
severity of complications
Time Frame: 4 years
4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Additionally patient satisfaction will be looked at based on post-operative questionnaire.
Time Frame: 4 years
how satisfied they were with seeing provider remotely vs standard of care
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwell Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Manish Vira, MD, Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-659

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings