Frequency of Parenteral and Non-Parenteral Exposures to Blood Among Healthcare Workers at the Clinical Center, NIH and at Seven Academic Hospitals in Japan
Primary Purpose
Hepatitis B, Hepatitis C, HIV Infection
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Hepatitis B focused on measuring Healthcare Worker, Bloodborne Diseases, Hepatitis B, Hepatitis C, Human Immunodeficiency Virus, Parenteral Exposure, Non-Parenteral Exposure, Blood and Body Substances, Universal Precautions, HIV Seronegativity
Eligibility Criteria
Nurses who work in the four cooperating institutions who have clinical responsibilities.
Sites / Locations
- National Institutes of Health Clinical Center (CC)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001712
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
1. Study Identification
Unique Protocol Identification Number
NCT00001712
Brief Title
Frequency of Parenteral and Non-Parenteral Exposures to Blood Among Healthcare Workers at the Clinical Center, NIH and at Seven Academic Hospitals in Japan
Official Title
Frequency of Parenteral and Non-Parenteral Exposures to Blood Among Healthcare Workers at the Clinical Center, NIH and at Seven Academic Hospitals in Japan
Study Type
Observational
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institutes of Health Clinical Center (CC)
4. Oversight
5. Study Description
Brief Summary
Following guidelines issued by the Centers for Disease Control, the Clinical Center implemented a Universal Precautions policy in November 1987 in an attempt to reduce healthcare workers' risks for occupational exposures to bloodborne pathogens. All hospital personnel whose jobs entailed potential exposure to patients' blood and body substances were required to attend a training session and complete a written examination. Based on data from surveys conducted before and twelve months after training in Universal Precautions, the frequency of cutaneous exposure to blood decreased by 50% in temporal association with implementation of Universal Precautions. Staff at the Clinical Center are required to take a refresher course in Universal Precautions annually.
The prevalence of bloodborne infections is high in Japan; however, Universal Precautions are not widely practiced in Japan. This study is designed: 1) to evaluate and compare nurses' knowledge of the epidemiology, pathogenesis, occupational risks, and appropriate prevention strategies for managing patients infected with bloodborne pathogens in the healthcare setting in seven university hospitals in Japan and at the Clinical Center of the National Institutes of Health in the US; 2) to compare self-reported levels of compliance with existing infection control recommendations designed to limit risk for exposure to bloodborne pathogens in all four institutions; 3) to compare self-reported frequencies of cutaneous exposures to blood at the four hospitals in the study; and 4) to evaluate the effect of educational intervention on nurses perceived compliance with recommendations and on the frequency of self-reported exposures to blood.
Detailed Description
Following guidelines issued by the Centers for Disease Control, the Clinical Center implemented a Universal Precautions policy in November 1987 in an attempt to reduce healthcare workers' risks for occupational exposures to bloodborne pathogens. All hospital personnel whose jobs entailed potential exposure to patients' blood and body substances were required to attend a training session and complete a written examination. Based on data from surveys conducted before and twelve months after training in Universal Precautions, the frequency of cutaneous exposure to blood decreased by 50% in temporal association with implementation of Universal Precautions. Staff at the Clinical Center are required to take a refresher course in Universal Precautions annually.
The prevalence of bloodborne infections is high in Japan; however, Universal Precautions are not widely practiced in Japan. This study is designed: 1) to evaluate and compare nurses' knowledge of the epidemiology, pathogenesis, occupational risks, and appropriate prevention strategies for managing patients infected with bloodborne pathogens in the healthcare setting in seven university hospitals in Japan and at the Clinical Center of the National Institutes of Health in the US; 2) to compare self-reported levels of compliance with existing infection control recommendations designed to limit risk for exposure to bloodborne pathogens in all four institutions; 3) to compare self-reported frequencies of cutaneous exposures to blood at the four hospitals in the study; and 4) to evaluate the effect of educational intervention on nurses perceived compliance with recommendations and on the frequency of self-reported exposures to blood.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Hepatitis C, HIV Infection
Keywords
Healthcare Worker, Bloodborne Diseases, Hepatitis B, Hepatitis C, Human Immunodeficiency Virus, Parenteral Exposure, Non-Parenteral Exposure, Blood and Body Substances, Universal Precautions, HIV Seronegativity
7. Study Design
Enrollment
3400 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Nurses who work in the four cooperating institutions who have clinical responsibilities.
Facility Information:
Facility Name
National Institutes of Health Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
1996583
Citation
Fahey BJ, Koziol DE, Banks SM, Henderson DK. Frequency of nonparenteral occupational exposures to blood and body fluids before and after universal precautions training. Am J Med. 1991 Feb;90(2):145-53.
Results Reference
background
PubMed Identifier
2376660
Citation
Willy ME, Dhillon GL, Loewen NL, Wesley RA, Henderson DK. Adverse exposures and universal precautions practices among a group of highly exposed health professionals. Infect Control Hosp Epidemiol. 1990 Jul;11(7):351-6. doi: 10.1086/646186.
Results Reference
background
PubMed Identifier
8038311
Citation
Beekmann SE, Vlahov D, Koziol DE, McShalley ED, Schmitt JM, Henderson DK. Temporal association between implementation of universal precautions and a sustained, progressive decrease in percutaneous exposures to blood. Clin Infect Dis. 1994 Apr;18(4):562-9. doi: 10.1093/clinids/18.4.562.
Results Reference
background
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Frequency of Parenteral and Non-Parenteral Exposures to Blood Among Healthcare Workers at the Clinical Center, NIH and at Seven Academic Hospitals in Japan
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