- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04692753
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
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Chandigarh, India, 160012
- Recruiting
- PGIMER
-
Contact:
- Dr. Rubina Sharma, MBBS
- Phone Number: 08427977607
- Email: rubinasharma7777@gmail.com
-
Contact:
- Dr. Neeru Sahni, MD
- Phone Number: 09872646106
- Email: neerunalin@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients admitted to Main ICU
Exclusion Criteria:
- Patients who refuse to give consent
Study Plan
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Other Study ID Numbers
- NK/6491/MD/147
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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