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

Vascular Access Devices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04692753
• Other study ID #: NK/6491/MD/147
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: April 2021

Study information

• Verified date: January 2021
• Source: Postgraduate Institute of Medical Education and Research, Chandigarh
• Contact: Dr. Rubina Sharma, MBBS
• Phone: 08427977607
• Email: rubinasharma7777[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients admitted to Main ICU

Exclusion Criteria:

• Patients who refuse to give consent

Related Conditions & MeSH terms

• Vascular Access Devices

Intervention

Other:
• Training and education
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

Locations

Country	Name	City	State
India	PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research, Chandigarh

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	to study improvement in documentation regarding venous access devices	effect of training and education will be studied on improvement in documentation of venous access devices in post intervention phase	seven months
Primary	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	the maintenance of venous access devices as evident from multiple point observations regarding condition of site ,dressing, connectors	Seven months
Secondary	effect of intensive training and education on incidence of CLABSI during pre and post intervention phase	incidence of central line associated blood stream infection to be compared between pre and post intervention phase	seven months