NCT06363175: PREMIERE

PREMs In Vascular SurgERy Enhancement Study

Not yet recruiting Last updated 15 April 2024

What this trial tests

trial in Vascular Diseases in 330 participants. Not yet recruiting.

Timeline

1 June 2024

Primary endpoint
1 August 2025

1 June 2026

Quick facts

Lead sponsor	Cardiff and Vale University Health Board
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	330
Start date	1 June 2024
Primary completion	1 August 2025
Estimated completion	1 June 2026
Sites	1 location across United Kingdom

Conditions studied

• Vascular Diseases — all drugs for Vascular Diseases →
• Patient Empowerment — all drugs for Patient Empowerment →
• Patient Satisfaction — all drugs for Patient Satisfaction →
• Patient Engagement — all drugs for Patient Engagement →

Sponsor

Cardiff and Vale University Health Board

Who can join

18 and older, any sex, with Vascular Diseases or Patient Empowerment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Darwish M, Palmer R, Coulson J, Bosanquet DC, et al · · 2025 · PMID 40617619 · DOI 10.1136/bmjopen-2024-089240