Venous Thromboembolism Prophylaxis in a Tertiary UAE Hospital: Comparison of Clinical Practice Guidelines. (VTE)

Study Title:Assessment of Adherence to Guidelines for Thromboprophylaxis in a Tertiary United Arab Emirates (UAE) hospital

Study Site: Al Qassimi Hospital, United Arab Emirates

Study Objectives:

The primary objective of this study is assessment of appropriateness of VTE prophylaxis administered to critically ill and surgical patients for whom pharmacologic treatment is indicated according to the American College of Chest Physicians (ACCP) 2012 guidelines.

The secondary objective is to:

1.Identify some causes of inadequate VTE prophylaxis in different patient populations, such as prescribing problems and errors at the level of administration.

Study Design: Cross sectional retrospective observational study

Sample size: Approximately 400

Study Population:

Inclusion criteria

Patients who meet the following criteria will be included:

1. Patients aged 18 and above.
2. Patients admitted to any of the critical care units, or the general or orthopaedic surgical wards.
3. Patients who have been in hospital more than 24 hours.
4. Caprini score > 1 (see procedure)

Exclusion criteria

Patients with any of the following criteria will be excluded:

1. Patients who have been admitted to a critical care unit and transferred out to a non surgical unit within 24 hours of admission.
2. Patients receiving oral anticoagulant therapy for indications other than VTE prophylaxis or treatment, such as atrial fibrillation and prosthetic heart valves.

Study Outcome Measurements:

The main outcome measure of interest is to determine the proportion of patients who have received inappropriate or inadequate VTE prophylaxis considering their calculated risk factor compared to the recommended prophylactic measures for that risk.

Secondary outcome measures are to identify whether there is inadequate VTE prophylaxis because of medication errors such as missed doses or wrong doses given.

Study Duration: 4 months

Statistical Analysis Data was entered into Microsoft Excel® and subsequently checked to ensure accurate data entry and correct any errors. It was subsequently exported into SPSS version 20 where it will be analysed.Quantitative data such as age was expressed mean (± standard deviation). Categorical data such as gender, risk factors for bleeding, type of mechanical and pharmacologic prophylaxis, missed doses and wrong doses were expressed as number and percentage of population.The student's t-test was used to analyse parametric data. The Pearson Chi-Square Test and Wilcoxon Rank sum test were used to analyse non parametric data. Simple and multiple logistic regression analysis was done to identify factors that are associated with inappropriate VTE prophylaxis. Factors that were included in the analysis included: age, type of admission (medical or surgical), area of admission (critical care, general surgery, orthopaedic surgery), Caprini score, and inappropriate VTE prophylaxis as the outcome. A p-value of less than 0.05 was be considered statistically significant.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism

• Study Type: Observational
• Enrollment (Actual): 386

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The targe sample is paients in critical care wards and orthopaedic surgery patients. All patients will be screened at discharge. Those who fulfill the inclusion/exclusion criteria will go on to have a thromboembolism risk assessment using the CapriniRisk Assessment Model. Those who have a score > 1 will be included for assessment of their VTE prophylaxis (from medical records). Approximately 60 patients are admitted into critical care units and 40 general and orthopaedic surgical patients are admitted to the surgical wards per month, giving a total sample of around 400 patients.

Description

Inclusion Criteria:

1. Patients aged 18 and above.
2. Patients admitted to any of the critical care units, or the general or orthopaedic surgical wards.
3. Patients who have been in hospital more than 24 hours.
4. Caprini score > 1 (see procedure)

Exclusion Criteria:

1. Patients who have been admitted to a critical care unit and transferred out to a non surgical unit within 24 hours of admission.
2. Patients receiving oral anticoagulant therapy for indications other than VTE prophylaxis or treatment, such as atrial fibrillation and prosthetic heart valves.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients receiving inappropriate or inadequate VTE prophylaxis	Case Report Form Analysis Form	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients receiving inadequate VTE prophylaxis due to medication errors, missed doses etc.	Case Report Form Analysis Form	2 weeks

Collaborators and Investigators

• Sponsor: Ministry of Health, United Arab Emirates
• Investigators: Principal Investigator: Ghada Al Tajir, Ph.D, Clinical Research Centre, Ministry of Health, United Arab Emirates

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: September 29, 2013
• First Submitted That Met QC Criteria: October 8, 2013
• First Posted (Estimate): October 9, 2013

Study Record Updates

• Last Update Posted (Estimate): October 9, 2013
• Last Update Submitted That Met QC Criteria: October 8, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: 122012-11