Effect of Education of Health Care Workers on the Maintenance of Venous Access Devices

Effect of Intensive Training and Education of Health Care Workers on the Maintenance of Venous Access Devices in Critically Ill Patients at a Tertiary Care Academic Hospital

In intensive care units (ICU), critically ill patients require various venous access devices for fluid resuscitation, drug therapy, or renal replacement therapy (RRT). These include peripheral intravenous catheters (PIVC), specialized venous ports like central venous catheters (CVCs), and hemodialysis ports. The investigators plan to do this pre- and post-intervention study to know the effect of intensive training and education of HCW (doctors and nurses) on the condition of venous access devices in critically ill patients.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

Phase 1, pre-intervention: The first twelve weeks will include 25 random visits to main ICU and point observations of all venous access devices under parameters like condition of dressing, connectors and documentation. This will also include the comparison of incidence of CLABSI in the pre and post intervention phase.

Phase 2, intervention: Next four weeks will be an intervention in the form of intensive training and education of the HCW (doctors and nurses). The intensive training will be in the form of an online presentation in which the investigators would have videos on care and maintenance of venous access devices, and the importance of documentation of days of insertion and change of dressing.

Phase 3, post-intervention: Another twelve weeks, post-intervention, again 25 random visits will be done to collect point observations about the same parameters of venous access devices and documentation as done in phase 1.

Statistical analysis: Each of these point observation parameters (for central or peripheral venous access) will be finally categorized as appropriate/inappropriate as per guidelines for best practice.

The compiled data from pre and post intervention phases would be compared. All the categorical parameters (appropriate/inappropriate) will be compared using chi-square test. All the quantitative parameters (e.g. incidence of CLABSI) will be compared using a paired t-test

Study Type

Observational

Enrollment (Anticipated)

400

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

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients admitted to Main ICU of PGIMER during the period of data collection

Description

Inclusion Criteria:

  • All patients admitted to Main ICU

Exclusion Criteria:

  • Patients who refuse to give consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-intervention
baseline data prior to training and education of health care workers. Intervention: intensive training and education of workers for maintenance of venous access devices.
Post intervention
observation after training and education of health care workers
Training and education of health care workers in the form of online seminars and bed side demonstration of care and maintenance of venous access devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To study the effect of intensive training and education of health care workers on care and maintenance of venous access devices in critically ill patients
Time Frame: Seven months
the maintenance of venous access devices as evident from multiple point observations regarding condition of site ,dressing, connectors
Seven months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect of intensive training and education on incidence of CLABSI during pre and post intervention phase
Time Frame: seven months
incidence of central line associated blood stream infection to be compared between pre and post intervention phase
seven months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
to study improvement in documentation regarding venous access devices
Time Frame: seven months
effect of training and education will be studied on improvement in documentation of venous access devices in post intervention phase
seven months

Collaborators and Investigators

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

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)

October 1, 2020

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

December 31, 2020

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

January 1, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • NK/6491/MD/147

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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