Innovation Adoption in Medical Robotic Surgery: Case of R... | NCT03684746

Studies
Innovation Adoption in Medical Robotic Surgery: Case of Royal Bournemouth Hospital

NCT03684746

Sponsor

Bournemouth University

Status

Completed

Last Update Posted

Jul 10, 2020Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Staff Attitude

Interventions

No Intervention

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2018Actual

Primary Completion Date

Jul 31, 2019Actual

Completion Date

Jul 31, 2019Actual

First Submitted Date

Jun 29, 2018

First Submission Date that Met QC Criteria

Sep 24, 2018

First Posted Date

Sep 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2020

Last Update Posted Date

Jul 10, 2020Actual

Name	Class
Royal Bournemouth Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Medial Experts		Including doctors- surgeons - consultants	Other: No Intervention
Care specialist		including nurses - before/after care staff	Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	It is an observational Study with staff	Care specialist Medial Experts

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being involved with conducting Robotic Surgery or caring for patients undergoing Robotic Surgery

Exclusion Criteria:

As this study is recruiting staff, and there is no medical intervention, the eligibility criteria is basic.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

90 Years

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Bournemouth Hospital		Bournemouth			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

I am not planning to share any data with other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided