Off-shift Robotic TeleroundingNCT01576614
The Role of Off-shift Robotic Telerounding Between Physicians and Nurses in the Surgical Intensive Care Unit
An observational study of Off-shift Robotic Telerounding, run by Lahey Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Off-shift Robotic Telerounding
- What is being tested?
- Remote physician rounding
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2013
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Full time Nursing and Physician Staff providing rounding services in the Surgical Intensive Care Unit
Who may be able to join
- Full time registered nursing staff
- Resident physicians and critical care attending physicians
Who cannot join
- Non-registered nursing staff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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.
- Conditions
- Off-shift Robotic Telerounding
- Being tested
- Remote physician rounding
- Keywords
- Comparing telephone VS RTP in SICU rounding practices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote physician roundingBehavioural
Also called RTP, Remote Telepresence Rounding, Telemedicne, Robotic rounds
Use of Remote physician rounding using Remote Telepresence Robotics
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Remote physician rounding | |
| 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. Receives: Behavioral: Remote physician rounding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collaboration and Satisfaction Survey About Care Decisions using CSACD Scores
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
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Off-shift Robotic TeleroundingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy N. Liesching, MD, Principal investigator, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576614
- Sponsor's protocol ID
- 2011-071
- Status last verified
- Sep 2013
- First submitted
- 10 Apr 2012
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01576614
- Acronym / sponsor ID
- 2011-071
- Conditions
- Off-shift Robotic Telerounding
- Keywords
- Comparing telephone VS RTP in SICU rounding practices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Apr 2012 (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.
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?
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-Physician Rounding by Phone | – | Behavioral: Remote physician roundingThe 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. |
| Nurse-Physican rounding by R T P | – | Behavioral: Remote physician roundingRemote 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Full time Nursing and Physician Staff providing rounding services in the Surgical Intensive Care Unit
Key inclusion criteria (2 listed)
- Full time registered nursing staff
- Resident physicians and critical care attending physicians
Key exclusion criteria (1 listed)
- Non-registered nursing staff
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 |
|---|---|---|
| Remote physician roundingAlso: RTP, Remote Telepresence Rounding, Telemedicne, Robotic roundsUse of Remote physician rounding using Remote Telepresence Robotics | Behavioural | Nurse-Physican rounding by R T P, Nurse-Physician Rounding by Phone |
Primary outcome
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
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 26 Sep 2013.
- Telemedicine providerLink provided by the sponsor.
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.
Timothy N. Liesching, MD principal investigator
Lahey Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Off-shift Robotic Telerounding, run by Lahey Clinic 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 1 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 26 Sep 2013. 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?
Collaboration and Satisfaction Survey About Care Decisions using CSACD Scores (time frame: One Year). 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 26 Sep 2013.