Determination of Venous Thromboembolism Risk and Nursing Practices in Patients Hospitalized in Medical Services

June 6, 2024 updated by: Humeyra Zengin, RN,PhD, Hacettepe University

Determination of Venous Thromboembolism Risk and Nursing Practices in Patients Hospitalized in Medical Services in a Tertiary University Hospital: Point Prevalence Study

Together with individual predisposition to form vascular clots and clinical conditions that further increase this risk, venous thromboembolism (VTE) poses a significant additional morbidity and mortality risk for the majority of the world's population. Although VTE causes serious disability and death when undiagnosed, it is a medical condition that can be prevented when diagnosed early. Although all hospitalized patients are at risk of DVT, studies have shown that 75% of hospitalized patients are hospitalized in internal clinics.As a result of this observational study, it was aimed to determine the VTE risk levels of the patients from the time of hospitalization and to determine preventive nursing care for VTE.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Venous Thromboembolism (VTE) refers to interrelated diagnoses such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). 10-20% of venous thromboembolic events occur in medical patients and 10-80% in intensive care patients. Recognized as a major complication for medical and surgical patients, VTE has been described as the 'silent killer' of hospitalized patients. During the Covid-19 pandemic in recent years, high rates of thrombolytic events have been reported in hospitalized COVID-19 patients. Nurses have an important role in identifying risk factors for VTE, taking precautions and assessing patient compliance with these precautions. The nurse should identify risk factors in the preoperative period, long-term and intensive care hospitalizations by taking a comprehensive history and physical assessment of the patient before hospitalization. There are several risk assessment models developed to assess the risk of VTE for application to inpatient medical patients. There are various risk assessment models developed for application to inpatient medical patients. Padua and IMPROVE VTE risk assessment models are frequently used. In the literature, it is stated that the Padua model gives moderate results and the IMPROVE model gives moderate-good results in predicting risk (1). Therefore, risk levels were not determined with the IMPROVE risk assessment tool in this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe Uviversity
    • Ankara
      • Altındağ, Ankara, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The population of the study will consist of patients hospitalized in the medical clinics of an Adult Hospital of a University. The Adult Hospital serving adult patients has a capacity of 801 beds and the number of beds allocated for medical services is 211.

Description

Inclusion Criteria:

  • To be conscious,
  • Consent of the patient's relatives to participate in the study in unconscious patients
  • 24 hours have passed since hospitalization
  • The patient admitted to hospitalization has been pre-assessed by the nurse and the pre-assessment form and nurse observation form have been completed

Exclusion Criteria:

  • Surgical patients
  • Pregnant patients
  • Refusing to participate in the study during the completion of the data collection forms.
  • In unconscious patients, the patient's relatives did not give consent to participate in the study
  • Unconscious patient whose relatives cannot be reached
  • The patient admitted to hospitalization was not pre-assessed by the nurse and the pre-assessment form and nurse observation form were not filled out

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determination of IMPROVE risk model risk levels according to deep vein thrombosis and pulmonary embolism risk factors
Time Frame: 21 February 2024
IMPROVE VTE Risk modeli,the seven risk factors evaluated in this model are history of VTE, thrombophilia, cancer in remission within the last 5 years, lower extremity paralysis or paresthesia (leg falling to the bed within 5 seconds), immobilization (complete immobility in bed or chair for ≥ 1 day), ICU (ICU)/Coronary ICU hospitalization, Age ≥ 60 years. In this model with a maximum of 12 points; 0-1 point range is defined as low VTE risk, 2-3 point range as moderate VTE risk and 4 points and above high VTE risk,
21 February 2024

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of implementation of nursing practices for VTE risk
Time Frame: 21 February 2024
Nursing Practise; Informing patients about VTE, To Mobilize the Patient Leg exercises in bed Compression Elastic Socks Intermittent Pneumatic Compression Evaluation of the lower extremities (calf pain, edema, discoloration, tenderness, temperature increase and pulse control, etc.) Daily monitoring of laboratory tests Evaluation of the Glasgow Coma Scale
21 February 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Humeyra Zengin, Director of Nursing Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 21, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HU-NS-VTERisk001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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