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Completed

NCT Number: NCT02375477

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

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.

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Key information

Conditions

Bacterial Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Difficile Infections

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • None

Medical Staff Criteria:

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Educational Intervention

Other

Given educational presentation

Other names: Education for Intervention, Intervention, Educational

Primary outcomes

  1. Rate of C. difficile infection

    Time frame: Up to 1 year

    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.

Secondary outcomes

  1. Proportion of patients with an isolation order placed concurrently with the order for C. difficile

    Time frame: Up to 1 year

    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.

  2. Difference in scores post-test minus pre-test

    Time frame: Baseline to up to 1 year

    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.

  3. Retention of information

    Time frame: Up to 1 year

    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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Mar 2, 2015
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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