PREMs In Vascular SurgERy Enhancement Study

NCT06363175 | Not Yet Recruiting DMC

• 2 other identifiers: 8737343073
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Vascular Diseases; Patient Empowerment; Patient Satisfaction; Patient Engagement; Surgery

Keywords

Patient Reported Experience Measure; PREM; Vascular surgery; Patient centred care

Outcome Measures

Primary Outcomes (4)

• Degree of Validity of the PREM

  Validity: The extent to which a measure assesses what it intends to measure.

  Day 0, Day 30

• Degree of Reliability of the PREM

  Reliability: The consistency and stability of a measure over time and across different conditions.

  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.

  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.

  Day 0, Day 30

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• Patients who lack capacity or suffer from cognitive impairment.
• Patients who are unable to speak, read and write English or Welsh.

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• Welsh Value in Health Centre (WViHC): collaborator
• Centre for Healthcare Evaluation, Device Assessment, and Research (CEDAR): collaborator

Study Sites (1)

Southeast Wales Vascular Network-Cardiff and Vale University Health Board

Cardiff, Wales, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40617619 DERIVED

MeSH Terms

Conditions

Vascular Diseases; Patient Participation; Patient Satisfaction

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• David C Bosanquet, FRCS

  CARDIFF & VALE UNIVERSITY LHB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maram Darwish, MD

CONTACT

+447841582039; maram.darwish@wales.nhs.uk

Rachel Norman

CONTACT

+442921846126; rachel.norman2@wales.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: June 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)