Improved Adherence to C. Difficile Isolation Protocols Through Improved Education Methods

Clostridium Difficile Clinical Trial

Official title:

Improved Adherence to C. Difficile Isolation Protocols Though Improved Inter-disciplinary Educational Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375477
• Other study ID #: CASE1815
• Secondary ID: NCI-2015-00147CA
• Status: Completed
• Phase: N/A
• First received: February 24, 2015
• Last updated: January 29, 2018
• Start date: January 27, 2015
• Est. completion date: January 6, 2018

Study information

• Verified date: January 2018
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial studies how well inter-disciplinary educational methods work in improving adherence to isolation protocols in patients with Clostridium (C.) difficile infections. An inter-disciplinary educational method may help to prevent the spread of infection.

Description:

PRIMARY OBJECTIVES:

I. To lower rates of C. difficile transmission through improved adherence to recommended isolation protocols.

SECONDARY OBJECTIVES:

I. Improve resident knowledge of infection control procedures and engagement in quality improvement initiatives.

OUTLINE:

Residents and nurses are given a short presentation on isolation protocols for diarrhea and enteric pathogens approved by Infection Control and covering their recommendations.

After completion of study, residents and nurses complete post-tests to determine the effectiveness of the training every 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 6, 2018
• Est. primary completion date: January 6, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Patient Criteria

Inclusion Criteria:

• Patient on the gynecologic oncology service

• Admitted to Seidman 6th floor of the Seidman Cancer Center

• Diarrhea or clinical concern for C. difficile infection

Exclusion Criteria:

Medical Staff Criteria:

Inclusion Criteria:

• Any resident or nurse treating a patient meeting the above criteria

Exclusion Criteria:

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Clostridium Difficile

Intervention

Other:
• Educational Intervention
Given educational presentation

Locations

Country	Name	City	State
United States	Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of C. difficile infection	Rates of infection before vs. after implementation of the intervention will be plotted by quarter and year over the entire study period, to examine possible time trends in the pre-intervention period. Rates during the post-intervention period will be compared to those in the pre-intervention period using logistic regression, adjusting for season of the year, age, race, and other potentially confounding factors.	Up to 1 year
Secondary	Proportion of patients with an isolation order placed concurrently with the order for C. difficile	The proportion will be compared pre- vs. post-intervention using logistic regression, adjusting for potentially confounding factors such as season, age, and race. In addition, Kaplan-Meier curves will be used to summarize the time from ordering C. difficile until the isolation order is placed, as well as the time from when the order was placed until it was acknowledged by the nurse, separately for pre- and post-intervention time periods. The curves will be compared between time periods using a logrank or Wilcoxon test allowing for the possibility of censored data.	Up to 1 year
Secondary	Difference in scores post-test minus pre-test	The difference in scores post-test minus pre-test will be calculated for each resident or nurse. The distribution of pre- and post-test scores and of the difference in scores will be summarized graphically and statistically using mean, median, standard deviation, and inter-quartile range. A paired t-test or non-parametric test such as the Wilcoxon signed rank test will be used to test whether there was an improvement in score from pre- to post-test. Analyses will be carried out separately for residents and nurses, as well as for residents and nurses combined.	Baseline to up to 1 year
Secondary	Retention of information	For residents or nurses who retake the exam, test scores will be summarized graphically and statistically for pre- and post-test, at the original and repeat session. Retention will be gauged by comparing the test score of the re-test with the pre- and post-test scores from the original test, using contrasts in a randomized block analysis of variance model, or using pairwise signed rank tests on the differences in scores.	Up to 1 year