The Role of Off-shift Robotic Telerounding Between Physicians and Nurses in the Surgical Intensive Care Unit

September 24, 2013 updated by: Lahey Clinic

A Prospective Randomized Study on the Role of Off-shift Robotic Telerounding on the Collaboration Between Physicians and Nurses in the Surgical Intensive Care Unit

Hypothesis: The use of a mobile robotic telepresence system for off-hours rounding in the surgical intensive care unit has an impact on nurse-physician collaboration.

Study question: Does the addition of mobile video communication provided by RTP affect nurse-physician collaboration during off shift rounding in the surgical intensive care unit when compared to the more common clinical practice of off-shift rounding using the telephone?

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

This is a mixed-method study, involving both surveys and ethnographic fieldwork. The research team will utilize the Collaboration and Satisfaction About Care Decisions (CSACD) survey instrument at regular intervals to assess nurse-physician collaboration. The instrument is validated and reliable and has been extensively tested. Permission was obtained to use the instrument. The ethnographic investigation will run concurrently and be performed by a doctoral student from Massachusetts Institute of Technology (MIT). No part of the study will involve patient intervention. The study will be conducted in the surgical intensive care unit (SICU).

The survey-based portion of the study is a prospective, randomized, crossover-controlled trial; it will generate ordinal data regarding nurse-physician collaboration and satisfaction. The ethnographic portion of the study will involve observation and interviews. The MIT student will engage in unobtrusive observational shadowing of APs and nurses throughout the study, and will formally interview each observed AP and nurse twice during the entire length of the study: once at the onset of the study, and once as the study draws to conclusion. This observational shadowing will include visits to the SICU. All participants will be consented for the study. Consent for and implementation of these methods will be undertaken in a manner consistent with current best research practice; extensive measures will be taken to protect staff confidentiality.

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.
Observational

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.
35

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
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Full time Nursing and Physician Staff providing rounding services in the Surgical Intensive Care Unit

Description

Inclusion Criteria:

  • Full time registered nursing staff
  • Resident physicians and critical care attending physicians

Exclusion Criteria:

  • Non-registered nursing staff

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Nurse-Physician Rounding by Phone
The SICU's practice involves daily morning team rounding at the bedside. The team includes the critical care attending physician (AP), surgical resident physician, and critical care nurse. The AP is physically present in the SICU during these rounds and for the hours between approximately 7am and 7pm. During off-shift hours (7pm-7am), the AP is available by phone as the "on-call" attending physician. In addition to this on-call availability, the standard of practice in SICU for years has been that the on-call physician proactively places a telephone call to the SICU at least once every evening to perform "telephone rounds" with the resident physician aeach SICU patient.
Behavioral: Remote physician rounding
Use of Remote physician rounding using Remote Telepresence Robotics
Other Names:
  • RTP
  • Remote Telepresence Rounding
  • Telemedicne
  • Robotic rounds
Nurse-Physican rounding by R T P

Remote Telepresence Robotics (RTP) is a form of telemedicine that enables a fast and direct face-to-face response by a physician, located remotely, and may sometime utilize a mobile robot.

RTP provides the physician the ability to teleconference with patients and other healthcare providers using two way audio visual technology. The sophistication of these devices varies and can range from simple video conferencing to remote robotic control devices with audio visual conferencing capabilities. The "robotic" capabilities refer to ability of the physician to remotely direct or drive the device from one location to another.

The technology allows clinical experts to provide the right care at the right time and has become an accepted standard of care when used under appropriate circumstances.
Behavioral: Remote physician rounding
Use of Remote physician rounding using Remote Telepresence Robotics
Other Names:
  • RTP
  • Remote Telepresence Rounding
  • Telemedicne
  • Robotic rounds

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
Measure Description
Time Frame
Collaboration and Satisfaction Survey About Care Decisions using CSACD Scores
Time Frame: One Year
This is a mixed-method study, involving both surveys and ethnographic fieldwork. The research team will utilize the Collaboration and Satisfaction About Care Decisions (CSACD) survey instrument at regular intervals to assess nurse-physician collaboration. The instrument is validated and reliable and has been extensively tested. Permission was obtained to use the instrument
One Year

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.
Lahey Clinic

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: Timothy N. Liesching, MD, Lahey Clinic

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.

Helpful Links

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

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.
August 1, 2011

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.
August 1, 2013

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.
September 1, 2013

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).
April 10, 2012

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.
April 11, 2012

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.
April 12, 2012

Study Record Updates

Last Update Posted (Estimate)

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.
September 26, 2013

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.
September 24, 2013

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.
September 1, 2013

More Information

Terms related to this study

Keywords

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.
  • 2011-071

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.

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