Robotic Staff ExperiencesNCT03453736
Staff Experiences in Robotic Theatres
An observational study of Robotic Staff Experiences, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Studies have shown that team work impacts patients safety. This is particularly the case in surgical theatres where individuals from different backgrounds (surgeon, anaesthetists, nurses, ..etc) work together to achieve a common goal which is looking after the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Robotic Staff Experiences
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jul 2018to 21 Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be theatre staff, from any surgical discipline, who are involved in robotic surgery practice at University Hospitals of Leicester and Cambridge University Hospital. This includes, but not limited to surgeons (primary and assistants), nurses (scrub, circulating, or student), anaesthetists (including trainees) and operating department practitioners (ODP).
Who may be able to join
- Robotic theatre staff as above.
- Willing and able to participate.
- Good command of the English language.
Who cannot join
- Theatre staff not involved in robotic surgery.
- Participants not willing / unable to participate.
- Staff that have not worked in a conventional theatre setup before.
- Inability to read/speak/understand English.
- Lack of capacity for consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester NHS Trust
Leicester
About this study
Official title: A Qualitative Study of Staff Experiences and Practices Within the Robotic Theatre Setup
Studies have shown that team work impacts patients safety. This is particularly the case in surgical theatres where individuals from different backgrounds (surgeon, anaesthetists, nurses, ..etc) work together to achieve a common goal which is looking after the patient. The robotic theatre set up is different due to the physical separation of the surgeon from the patient and the rest of the team. This may represent a communication challenge. The Study investigators aim to study theatre staff experiences and practices of communication and teamwork in this special setup, investigating any challenges participants may be facing and possible ways of adapting to them. Staff opinions and suggestions for improvement will be explored for utmost surgical performance and patient safety.
The study will involve two parts:1) individual staff interviews and 2) teamwork observations during real life surgery. The two parts should complement each other giving an overall picture of the teamwork in the robotic theatre setup.
- Conditions
- Robotic Staff Experiences
- Being tested
- No intervention
- Keywords
- Robotic surgery, theatre staff, teamwork, patient safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a qualitative study involving staff interviews and observations. No intervention is being applied.
| Study group | Role | What they receive |
|---|---|---|
| Robotic procedures | Experiences and practices in Robotic theatres will be studied via semi-structured interviews with staff as well as team observations during real time robotic surgery. As the study is a qualitative one, data collection will continue till we reach saturation of theoretical categories. We expect 20 interviews and 10 observations to suffice. Receives: Other: No intervention | |
| Non-Robotic procedures | Staff involved in robotic surgery will have almost definitely worked in non-robotic theatres ie major abdominal and laparoscopic. Staff interviews will explore differences in experiences and practices between these different theatre setups.
In addition, we aim to observe further 5 non-robotic procedures to evaluate staff teamwork and communication within the more regular theatre setup. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Robotic staff experiences.
This will be explored using individual interviews and team observations. Textual data of interview transcripts and observation field notes will be analysed using constant comparative method.
Measured: 1 year
Robotic staff practices
This will be explored using individual interviews and team observations. Textual data of interview transcripts and observation field notes will be analysed using constant comparative method.
Measured: 1 year
Secondary outcomes (2)
Staff communication in robotic theatres.
This will be explored using individual interviews and team observations. Textual data of interview transcripts and observation field notes will be analysed using constant comparative method.
Measured: 1 year
Staff teamwork
This will be explored using individual interviews and team observations. Textual data of interview transcripts and observation field notes will be analysed using constant comparative method.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start8 Jul 2018
- Primary completion21 Mar 2019
- Study completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Staff ExperiencesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453736
- Sponsor's protocol ID
- 0647
- Other IDs
- 237227
- Status last verified
- Apr 2021
- First submitted
- 19 Feb 2018
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study of Staff Experiences and Practices Within the Robotic Theatre Setup
- ClinicalTrials.gov ID
- NCT03453736
- Acronym / sponsor ID
- 0647
- Conditions
- Robotic Staff Experiences
- Keywords
- Robotic surgery, theatre staff, teamwork, patient safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 8 Jul 2018 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 5 Mar 2018 (actual)
- 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.
Studies have shown that team work impacts patients safety. This is particularly the case in surgical theatres where individuals from different backgrounds (surgeon, anaesthetists, nurses, ..etc) work together to achieve a common goal which is looking after the patient. The robotic theatre set up is different due to the physical separation of the surgeon from the patient and the rest of the team. This may represent a communication challenge. The Study investigators aim to study theatre staff experiences and practices of communication and teamwork in this special setup, investigating any challenges participants may be facing and possible ways of adapting to them. Staff opinions and suggestions for improvement will be explored for utmost surgical performance and patient safety.
The study will involve two parts:1) individual staff interviews and 2) teamwork observations during real life surgery. The two parts should complement each other giving an overall picture of the teamwork in the robotic theatre setup.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic procedures | – | Other: No interventionExperiences and practices in Robotic theatres will be studied via semi-structured interviews with staff as well as team observations during real time robotic surgery. As the study is a qualitative one, data collection will continue till we reach saturation of theoretical categories. We expect 20 interviews and 10 observations to suffice. |
| Non-Robotic procedures | – | Other: No interventionStaff involved in robotic surgery will have almost definitely worked in non-robotic theatres ie major abdominal and laparoscopic. Staff interviews will explore differences in experiences and practices between these different theatre setups. In addition, we aim to observe further 5 non-robotic procedures to evaluate staff teamwork and communication within the more regular theatre setup. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be theatre staff, from any surgical discipline, who are involved in robotic surgery practice at University Hospitals of Leicester and Cambridge University Hospital. This includes, but not limited to surgeons (primary and assistants), nurses (scrub, circulating, or student), anaesthetists (including trainees) and operating department practitioners (ODP).
Key inclusion criteria (3 listed)
- Robotic theatre staff as above.
- Willing and able to participate.
- Good command of the English language.
Key exclusion criteria (5 listed)
- Theatre staff not involved in robotic surgery.
- Participants not willing / unable to participate.
- Staff that have not worked in a conventional theatre setup before.
- Inability to read/speak/understand English.
- Lack of capacity for consent.
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 |
|---|---|---|
| No interventionThis is a qualitative study involving staff interviews and observations. No intervention is being applied. | Other | Non-Robotic procedures, Robotic procedures |
Primary outcome
Robotic staff experiences.
Time frame: 1 year
This will be explored using individual interviews and team observations. Textual data of interview transcripts and observation field notes will be analysed using constant comparative method.
Robotic staff practices
Time frame: 1 year
This will be explored using individual interviews and team observations. Textual data of interview transcripts and observation field notes will be analysed using constant comparative method.
2 secondary outcomes
Staff communication in robotic theatres.
Time frame: 1 year
Staff teamwork
Time frame: 1 year
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 3 May 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Robotic Staff Experiences, run by University of Leicester at 1 site in United Kingdom.
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 3 inclusion and 5 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 3 May 2021. 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 Kingdom. 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?
Robotic staff experiences. (time frame: 1 year). The study lists 2 primary outcomes in all. 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 3 May 2021.