Vascular DiseasesPREMIERENCT06363175
PREMs In Vascular SurgERy Enhancement Study
An observational study of Vascular Diseases and Patient Empowerment, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases, Patient Empowerment, Patient Satisfaction
- How many people
- 330 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2024to 1 Jun 2026
- 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: Patients undergoing in-patient vascular care, which involves specialized vascular surgery for hospital-admitted individuals, including those recently discharged with conditions like peripheral artery disease. Recruitment will engage patients preoperatively and post-service (within 1-3 months) to minimize bias. The study will target UK's central vascular units for diverse patient demographics. Consistent eligibility criteria will apply to both study phases (development and validation).
Who may be able to join
- Patients who have recently (within the last three months) undergone a vascular procedure or intervention under the care of a vascular surgery team in the inpatient setting.
- Adults aged 18 years or older
- Not cognitively impaired (as determined by medical reports and/or self-reporting).
- Willing and able to provide written consent for participation.
- Able to speak, read and write English or Welsh
Who cannot join
- Patients who lack capacity or suffer from cognitive impairment.
- Patients who are unable to speak, read and write English or Welsh.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southeast Wales Vascular Network-Cardiff and Vale University Health Board
Cardiff, Wales
About this study
Official title: Patient-Reported Experience Measures in Vascular Surgery Enhancement Study
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 people's blood vessels (arteries and veins).
Read more
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.
Read the 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 patient's 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.
- Keywords
- Patient Reported Experience Measure, PREM, Vascular surgery, Patient centred care
- Medical subject headings
- Vascular Diseases, Patient Participation, Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Validity of the PREM
Validity: The extent to which a measure assesses what it intends to measure.
Measured: Day 0, Day 30
Degree of Reliability of the PREM
Reliability: The consistency and stability of a measure over time and across different conditions.
Measured: Day 0, Day 30
Degree of Responsiveness of the PREM
Responsiveness: The ability of a measure to detect change over time in the concept being measured.
Measured: Day 0, Day 30
Degree of Feasibility of implementing the PREM in clinical practice
Feasibility: The practicality and suitability of implementing a measure in a specific setting or context.
Measured: Day 0, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies 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
- Cross-sectional
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- Welsh Value in Health Centre (WViHC), Centre for Healthcare Evaluation, Device Assessment, and Research (CEDAR)
- Responsible party
- Sponsor
- Investigators
- David C Bosanquet, FRCS, Principal investigator, CARDIFF & VALE UNIVERSITY LHB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363175
- Sponsor's protocol ID
- 8737
- Other IDs
- 343073
- Acronym
- PREMIERE
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The full dataset is not expected to be made available for secondary research. In accordance with standard measures to prevent statistical disclosure, quantitative data relating to five or fewer individuals will be aggregated or redacted prior to publication. Similarly, full focus group transcripts will not be made available to external individuals or organisations due to the possibility of statistical disclosure from these qualitative data.
Publications
Darwish M, Palmer R, Coulson J, Bosanquet DC, Withers K. Patient-Reported Experience Measures in Vascular Surgery Enhancement (PREMIERE) study: protocol for a mixed-methods study to develop and validate a vascular surgery-specific patient-reported experience measure. BMJ Open. 2025 Jul 5;15(7):e089240. doi: 10.1136/bmjopen-2024-089240.
PubMed 40617619
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Experience Measures in Vascular Surgery Enhancement Study
- ClinicalTrials.gov ID
- NCT06363175
- Acronym / sponsor ID
- PREMIERE / 8737
- Keywords
- Patient Reported Experience Measure, PREM, Vascular surgery, Patient centred care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- Welsh Value in Health Centre (WViHC), Centre for Healthcare Evaluation, Device Assessment, and Research (CEDAR)
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 12 Apr 2024 (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.
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 people's 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 patient's 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing in-patient vascular care, which involves specialized vascular surgery for hospital-admitted individuals, including those recently discharged with conditions like peripheral artery disease. Recruitment will engage patients preoperatively and post-service (within 1-3 months) to minimize bias. The study will target UK's central vascular units for diverse patient demographics. Consistent eligibility criteria will apply to both study phases (development and validation).
Key inclusion criteria (5 listed)
- Patients who have recently (within the last three months) undergone a vascular procedure or intervention under the care of a vascular surgery team in the inpatient setting.
- Adults aged 18 years or older
- Not cognitively impaired (as determined by medical reports and/or self-reporting).
- Willing and able to provide written consent for participation.
- Able to speak, read and write English or Welsh
Key exclusion criteria (2 listed)
- Patients who lack capacity or suffer from cognitive impairment.
- Patients who are unable to speak, read and write English or Welsh.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Degree of Validity of the PREM
Time frame: Day 0, Day 30
Validity: The extent to which a measure assesses what it intends to measure.
Degree of Reliability of the PREM
Time frame: Day 0, Day 30
Reliability: The consistency and stability of a measure over time and across different conditions.
Degree of Responsiveness of the PREM
Time frame: Day 0, Day 30
Responsiveness: The ability of a measure to detect change over time in the concept being measured.
Degree of Feasibility of implementing the PREM in clinical practice
Time frame: Day 0, Day 30
Feasibility: The practicality and suitability of implementing a measure in a specific setting or context.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Derived from this study: PubMed 40617619Darwish M, Palmer R, Coulson J, Bosanquet DC, Withers K. Patient-Reported Experience Measures in Vascular Surgery Enhancement (PREMIERE) study: protocol for a mixed-methods study to develop and validate a vascular surgery-specific patient-reported experience measure. BMJ Open. 2025 Jul 5;15(7):e089240. doi: 10.1136/bmjopen-2024-089240.
- Individual participant dataSharing planned: No. The full dataset is not expected to be made available for secondary research. In accordance with standard measures to prevent statistical disclosure, quantitative data relating to five or fewer individuals will be aggregated or redacted prior to publication. Similarly, full focus group transcripts will not be made available to external individuals or organisations due to the possibility of statistical disclosure from these qualitative data.
Related trials for Vascular Diseases
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 1/2
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
Relapsed/Refractory Multiple Myeloma
RecruitingPhase 4
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Class I/II Obesity
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
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.
David C Bosanquet, FRCS principal investigator
CARDIFF & VALE UNIVERSITY LHB
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 Vascular Diseases and Patient Empowerment, run by Cardiff and Vale University Health Board 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 5 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: status not confirmed, as of the sponsor's last update on 15 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maram Darwish, MD (+447841582039, maram.darwish@wales.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Validity of the PREM (time frame: Day 0, Day 30). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06363175, which also lists 1 linked publication.
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 15 Apr 2024.