- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05433623
Vascular Surgery Admissions in a Tertiary Care Hospital in the Mid-West: A 12 Month Profile.
Study Overview
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fiona Leahy, MSc
- Phone Number: 061 588394
- Email: fionac.leahy@hse.ie
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Vascular Surgery Admissions
Patients who present and/or are admitted to University Hospital Limerick under the care of a Vascular Consultant.
|
It will be documented if the patient underwent surgery for their vascular issue
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Frailty Scale
Time Frame: 1 year
|
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
|
Charlson Co-Morbidity Scale
Time Frame: 1 year
|
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
|
Admission details
Time Frame: 1 year
|
Length of stay, interventions, referral source will be documented
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DVS001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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