Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363175
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-09
Brief Title:
PREMs In Vascular SurgERy Enhancement Study
Sponsor:
Cardiff and Vale University Health Board
Organization:
Cardiff and Vale University Health Board
Study Overview
Official Title:
Patient-Reported Experience Measures in Vascular Surgery Enhancement Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREMIERE
Brief Summary:
THE PROBLEM
Patient Reported Experience Measures PREMs ask patients about their healthcare service experience It gives them a voice to share their views PREMs allow healthcare providers HCPs to see where care is good and where they could improve Vascular surgery is a surgical speciality looking after peoples blood vessels arteries and veins
There is no PREM available for vascular patients The research team want to create a PREM for this patient group
WHY IT IS IMPORTANT
A PREM allows HCPs to record and understand patients experiences of their treatment It gives patients a way to provide feedback on their healthcare experience PREMs can help HCPs make changes to patients care identifying areas of good practice and areas for improvement The Welsh Government is keen to support the use of PREMs
AIMS
To develop a PREM specific to vascular surgery patients
RESEARCH PLAN
The research team will summarise the literature about PREMs in surgery The research team will then run focus groups and interviews with patients and staff to create a draft PREM for vascular patients in Wales The draft PREM will be translated into Welsh
In the second phase a larger number of vascular patients 100-300 depending on how long the draft PREM is from hospitals across Wales will complete the questionnaire Statistical tests will look at the results to see if the questionnaire works well to capture patients experiences Based on these results small changes will be made to make the draft PREM better This will make sure the final PREM is ready for widespread use in Wales and beyond
PATIENT AND PUBLIC INVOLVEMENT
The patients experience team at CAVUHB has reviewed our patients materials Our research team includes PPI co-applicants DC and AH DC a double amputee who has had many vascular operations DC has experience raising awareness about vascular disease through public forums like the Limbless Association Charity and BBC Radio Wales AH has issues with her leg due to smoking and had a keyhole operation to help with that She had some problems after the procedure This is her first time as a PPI representative DC and AH supported our research design and will be steering group members Also our research focuses on giving patients a voice and will include patients across Wales A diverse group of patients will be involved across all stages of the PREM development
Patient Reported Experience Measures PREMs ask patients about their healthcare service experience It gives them a voice to share their views PREMs allow healthcare providers HCPs to see where care is good and where they could improve Vascular surgery is a surgical speciality looking after peoples blood vessels arteries and veins
There is no PREM available for vascular patients The research team want to create a PREM for this patient group
WHY IT IS IMPORTANT
A PREM allows HCPs to record and understand patients experiences of their treatment It gives patients a way to provide feedback on their healthcare experience PREMs can help HCPs make changes to patients care identifying areas of good practice and areas for improvement The Welsh Government is keen to support the use of PREMs
AIMS
To develop a PREM specific to vascular surgery patients
RESEARCH PLAN
The research team will summarise the literature about PREMs in surgery The research team will then run focus groups and interviews with patients and staff to create a draft PREM for vascular patients in Wales The draft PREM will be translated into Welsh
In the second phase a larger number of vascular patients 100-300 depending on how long the draft PREM is from hospitals across Wales will complete the questionnaire Statistical tests will look at the results to see if the questionnaire works well to capture patients experiences Based on these results small changes will be made to make the draft PREM better This will make sure the final PREM is ready for widespread use in Wales and beyond
PATIENT AND PUBLIC INVOLVEMENT
The patients experience team at CAVUHB has reviewed our patients materials Our research team includes PPI co-applicants DC and AH DC a double amputee who has had many vascular operations DC has experience raising awareness about vascular disease through public forums like the Limbless Association Charity and BBC Radio Wales AH has issues with her leg due to smoking and had a keyhole operation to help with that She had some problems after the procedure This is her first time as a PPI representative DC and AH supported our research design and will be steering group members Also our research focuses on giving patients a voice and will include patients across Wales A diverse group of patients will be involved across all stages of the PREM development
Detailed Description:
Background PREMs have emerged as instruments designed to capture patients experiences of their healthcare journey No PREMs have been developed or validated to be used among vascular surgery patients specifically
Objectives To develop and validate a PREM specific to vascular surgery assessing the patients experience and satisfaction with their care and treatment
Study design and methods Patient Reported Experience Measures In Vascular Surgery Enhancement Study PREMIERE is a multi-site sequential mixed-methods cohort design incorporating qualitative and quantitative approaches in two phases The first phase will focus on developing a draft PREM for vascular surgery patients while the second phase will aim to validate the draft PREM to create a final PREM Patient inclusion criteria are i age 18 ii have undergone a vascular procedure iii experienced an inpatient vascular care within the previous 3 months iv not cognitively impaired v willing and able to provide written consent for participation vi able to communicate in English or Welsh
Statistical analysis For the qualitative phase inductive thematic analysis will be carried out using the non-numerical data analysis for Windows software NVivo For quantitative data psychometric tests such as item analysis internal consistency construct validity and principal component analysis with varimax rotation will be used to extract factors Quantitative data will be analysed using IBM SPSS Statistics Version 27 software
Anticipated impact PREMIERE will contribute to the development of a robust and context-specific PREM for vascular patients This PREM will provide a valuable tool for assessing and improving the in-patient vascular surgery pathway including pre-operative peri-operative and post-operative phases Also the utilization of a robust vascular PREM presents a transformative opportunity to benchmark and enhance the performance of vascular units
Objectives To develop and validate a PREM specific to vascular surgery assessing the patients experience and satisfaction with their care and treatment
Study design and methods Patient Reported Experience Measures In Vascular Surgery Enhancement Study PREMIERE is a multi-site sequential mixed-methods cohort design incorporating qualitative and quantitative approaches in two phases The first phase will focus on developing a draft PREM for vascular surgery patients while the second phase will aim to validate the draft PREM to create a final PREM Patient inclusion criteria are i age 18 ii have undergone a vascular procedure iii experienced an inpatient vascular care within the previous 3 months iv not cognitively impaired v willing and able to provide written consent for participation vi able to communicate in English or Welsh
Statistical analysis For the qualitative phase inductive thematic analysis will be carried out using the non-numerical data analysis for Windows software NVivo For quantitative data psychometric tests such as item analysis internal consistency construct validity and principal component analysis with varimax rotation will be used to extract factors Quantitative data will be analysed using IBM SPSS Statistics Version 27 software
Anticipated impact PREMIERE will contribute to the development of a robust and context-specific PREM for vascular patients This PREM will provide a valuable tool for assessing and improving the in-patient vascular surgery pathway including pre-operative peri-operative and post-operative phases Also the utilization of a robust vascular PREM presents a transformative opportunity to benchmark and enhance the performance of vascular units
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 343073 | OTHER | Integrated Research Application system IRAS | None |