PREMs In Vascular SurgERy Enhancement Study (PREMIERE)

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).

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Diseases; Surgery; Patient Engagement; Patient Satisfaction; Patient Empowerment

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 Type: Observational
• Enrollment (Estimated): 330

Contacts and Locations

• Study Contact: Name: Maram Darwish, MD; Phone Number: +447841582039; Email: maram.darwish@wales.nhs.uk
• Study Contact Backup: Name: Rachel Norman; Phone Number: +442921846126; Email: rachel.norman2@wales.nhs.uk

Study Locations

• United Kingdom
  • Wales
    • Cardiff, Wales, United Kingdom
      • Southeast Wales Vascular Network-Cardiff and Vale University Health Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cardiff and Vale University Health Board
• Collaborators: Welsh Value in Health Centre (WViHC); Centre for Healthcare Evaluation, Device Assessment, and Research (CEDAR)
• Investigators: Principal Investigator: David C Bosanquet, FRCS, Cardiff & Vale University LHB

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Vascular surgery; Patient Reported Experience Measure; PREM; Patient centred care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 8737; 343073 (Other Identifier: Integrated Research Application system (IRAS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No