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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | February 1998 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001712 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | 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 ICMJE | Frequency of Parenteral and Non-Parenteral Exposures to Blood Among Healthcare Workers at the Clinical Center, NIH and at Seven Academic Hospitals in Japan |
| 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. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 3400 |
| Completion Date | October 2005 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Nurses who work in the four cooperating institutions who have clinical responsibilities. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001712 |
| Responsible Party | |
| Study ID Numbers ICMJE | 980066, 98-CC-0066 |
| Study Sponsor ICMJE | National Institutes of Health Clinical Center (CC) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | October 2005 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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