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

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

Study Overview

• Status: Completed
• Conditions: Bacterial Infection; Clostridium Difficile
• Intervention / Treatment: Other: Educational Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health services research (isolation protocol education); Residents and nurses are given an educational intervention on isolation protocols for diarrhea and enteric pathogens approved by Infection Control and covering their recommendations.	Other: Educational Intervention; Given educational presentation; Other Names: Education for Intervention; Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: John Nakayama, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2015
• Primary Completion (Actual): January 6, 2016
• Study Completion (Actual): January 6, 2018

Study Registration Dates

• First Submitted: February 24, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: adherence; Clostridium difficile; C. difficile
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: CASE1815 (Other Identifier: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract); NCI-2015-00147 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No