Staff AttitudeNCT03684746
Innovation Adoption in Medical Robotic Surgery: Case of Royal Bournemouth Hospital
An observational study of Staff Attitude, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
This research sets to address two key areas. The first is identified by the researcher in academic literature that there is a lack of a comprehensive innovation adoption model in UK National Health System (NHS), specifically for Medical Robotic Surgery. Read more about this study
- Who is it for?
- Ages Up to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Staff Attitude
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jul 2018to 31 Jul 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 Up to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Medical experts and hospital staff involved directly on indirectly in Robotic Surgery at the NHS site - these individuals will have the necessary knowledge to contribute to this study.
Who may be able to join
- Being involved with conducting Robotic Surgery or caring for patients undergoing Robotic Surgery
Who cannot join
- -
- As this study is recruiting staff, and there is no medical intervention, the eligibility criteria is basic.
Trial locations and contacts
1 site in 1 country.
About this study
This research sets to address two key areas. The first is identified by the researcher in academic literature that there is a lack of a comprehensive innovation adoption model in UK National Health System (NHS), specifically for Medical Robotic Surgery. Existing frameworks are mainly developed in the US or in other fields. The second problem was identified by surgeons involved in Robotic Surgery in Royal Bournemouth Hospital (RBH). The project started by offering RBH a deeper understanding of the innovation adoption process, issues and development of an adapted innovation model, however after our initial meeting with the Surgical Director and his team, it was clear that one the main areas RBH was keen for us to investigate, was the communication pathway of all stakeholders involved in robotic surgery adoption. They were concerned that key staff dealing with patients undergoing medical robotic surgery were uninformed about the technology and process which can impact patients' experience and staff communication.
The research will develop a comprehensive innovation adoption model for robotic surgery (and similar medical innovation) in NHS. Currently there are no models adapted to NHS UK structure and requirements. This model will assist the NHS to understand and evaluate any innovation adoption process within the NHS and to avoid future innovation adoption failure.
The case example will Identify the communication pathway and key stakeholders in RBH for the process of Gastrointestinal Robotic Surgery, evaluation of stakeholders' knowledge and needs and further proposing ways to improve adoption and increase knowledge. NHS can use the proposed communication pathway to identify stakeholders that need to be informed, trained and communicated to, in any innovation adoption process within NHS.
- Conditions
- Staff Attitude
- Being tested
- No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
It is an observational Study with staff
| Study group | Role | What they receive |
|---|---|---|
| Medial Experts | Including doctors- surgeons - consultants Receives: Other: No Intervention | |
| Care specialist | including nurses - before/after care staff Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Innovation Framework
To develop a 'Surgical Innovation Framework' through discussion with surgeons, medical experts and staff at the research site. This framework would then be of use to other medical/surgical areas within the NHS, as there is currently no model adapted to the NHS' needs and requirements. The research will increase knowledge and enable better communication.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start11 Jul 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staff AttitudeStudies 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
- Other
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Bournemouth Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684746
- Sponsor's protocol ID
- 1718/IRASMSE/1
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2018
- Last updated
- 10 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I am not planning to share any data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation Adoption in Medical Robotic Surgery: Case of Royal Bournemouth Hospital
- ClinicalTrials.gov ID
- NCT03684746
- Acronym / sponsor ID
- 1718/IRASMSE/1
- Conditions
- Staff Attitude
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Royal Bournemouth Hospital
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 26 Sep 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.
This research sets to address two key areas. The first is identified by the researcher in academic literature that there is a lack of a comprehensive innovation adoption model in UK National Health System (NHS), specifically for Medical Robotic Surgery. Existing frameworks are mainly developed in the US or in other fields. The second problem was identified by surgeons involved in Robotic Surgery in Royal Bournemouth Hospital (RBH). The project started by offering RBH a deeper understanding of the innovation adoption process, issues and development of an adapted innovation model, however after our initial meeting with the Surgical Director and his team, it was clear that one the main areas RBH was keen for us to investigate, was the communication pathway of all stakeholders involved in robotic surgery adoption. They were concerned that key staff dealing with patients undergoing medical robotic surgery were uninformed about the technology and process which can impact patients' experience and staff communication.
The research will develop a comprehensive innovation adoption model for robotic surgery (and similar medical innovation) in NHS. Currently there are no models adapted to NHS UK structure and requirements. This model will assist the NHS to understand and evaluate any innovation adoption process within the NHS and to avoid future innovation adoption failure.
The case example will Identify the communication pathway and key stakeholders in RBH for the process of Gastrointestinal Robotic Surgery, evaluation of stakeholders' knowledge and needs and further proposing ways to improve adoption and increase knowledge. NHS can use the proposed communication pathway to identify stakeholders that need to be informed, trained and communicated to, in any innovation adoption process within NHS.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medial Experts | – | Other: No InterventionIncluding doctors- surgeons - consultants |
| Care specialist | – | Other: No Interventionincluding nurses - before/after care staff |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Medical experts and hospital staff involved directly on indirectly in Robotic Surgery at the NHS site - these individuals will have the necessary knowledge to contribute to this study.
Key inclusion criteria (1 listed)
- Being involved with conducting Robotic Surgery or caring for patients undergoing Robotic Surgery
Key exclusion criteria (2 listed)
- -
- As this study is recruiting staff, and there is no medical intervention, the eligibility criteria is basic.
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 InterventionIt is an observational Study with staff | Other | Care specialist, Medial Experts |
Primary outcome
Surgical Innovation Framework
Time frame: 6 months
To develop a 'Surgical Innovation Framework' through discussion with surgeons, medical experts and staff at the research site. This framework would then be of use to other medical/surgical areas within the NHS, as there is currently no model adapted to the NHS' needs and requirements. The research will increase knowledge and enable better communication.
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 10 Jul 2020.
- Individual participant dataSharing planned: No. I am not planning to share any data with other researchers.
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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 Staff Attitude, run by Bournemouth University 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 1 inclusion and 2 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 10 Jul 2020. 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?
Surgical Innovation Framework (time frame: 6 months). 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 10 Jul 2020.