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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05433623
Other study ID # DVS001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2024
Est. completion date September 1, 2025

Study information

Verified date November 2023
Source University Hospital of Limerick
Contact Fiona Leahy, MSc
Phone 061 588394
Email fionac.leahy@hse.ie
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Creating a 12 month profile of Vascular Surgery Admissions aims to inform service delivery and optimise patient care resources. There is a gap in the literature pertaining to this topic, particularly from an Irish perspective. This research could inform a clinical pathway to reduce LOS for patients cared for by the Department of Vascular Surgery.


Description:

This is an observational cross sectional study. This study will be mixed methods. Following the profile creation the researcher aims to complete qualitative research in the form of interviewing a cohort of vascular patients about their experiences in order to inform practice development. Ethics approval will be granted prior to any activities taking place. Selection/Recruitment: Patients attending UHL deemed to have vascular care needs and assigned to the care of a Vascular Consultant will be included in this study. The data will be collected 12 months from the date of commencing the study. Vascular consults will be excluded for the purpose for this research unless care is transferred. Informed consent is not required for this research so there in no exclusion criteria in relation to ability to provide same. Data Collection: The data to inform this project will be collected from medical chart review and utilising the UHL inpatient IT systems. No patient identifiers will be collected for this research and it will comply with GDPR. The Ipims system will be used to measure current inpatients under the care of a Vascular Consultant. HIPE data will be requested to examine the length of stay for vascular inpatients. The individual's medical notes will be reviewed to assess: - Reason for admission to hospital and/or presentation to the Emergency Department (ED). - Date, day and time of admission. - Referral source. - Categorisation from triage in the ED if applicable. - Consultant caring for the individual. - Demographic profile & Brief Medical and Surgical History. - ? Elective or Emergency admission. - ? Intervention or conservative management. Treatment course. - ? Re-admission. - Length of stay. - Time patient waited for theatre procedure (date of admission to date of theatre) including fasting time. - Time patient waited for vascular scans (date of admission to date of scans) & scans completed. - Time patient waited for rehab (transfer) if applicable. - Time patient waited for OPAT if applicable. - Clinical Frailty Scale (Appendix II) & Charlson Co-Morbidity Scale (Appendix III) (no patient intervention required). Data Analysis: Descriptive statistics with multivariant analyses. Process Evaluation: The MRC Framework will be employed for process evaluation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 650
Est. completion date September 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients attending UHL deemed to have vascular care needs and assigned to the care of a Vascular Consultant will be included in this study. - The data will be collected 12 months from the date of commencing the study. Exclusion Criteria: - Patients outside of the set dates will be excluded. - Vascular consults will be excluded for the purpose of this research unless care is transferred.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgery
It will be documented if the patient underwent surgery for their vascular issue

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Limerick

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Frailty Scale Clinical frailty score will be determined for vascular patient admissions. This is a 9 point scale. the higher the score means the greater the risk. 1 year
Primary Charlson Co-Morbidity Scale Scoring will be determined for vascular patient admissions. The Charlson Comorbidity Index (CCI) assesses comorbidity level by taking into account both the number and severity of 19 pre-defined comorbid conditions. It provides a weighted score of a client's comorbidities which can be used to predict short term and long-term outcomes such as function, hospital length of stay and mortality rates. 1 year
Primary Admission details Length of stay, interventions, referral source will be documented 1 year
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