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

Primary Purpose

Bacterial Infection, Clostridium Difficile

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bacterial Infection focused on measuring Clostridium difficile, C. difficile, adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health services research (isolation protocol education)

Arm Description

Residents and nurses are given an educational intervention on isolation protocols for diarrhea and enteric pathogens approved by Infection Control and covering their recommendations.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 24, 2015
Last Updated
January 29, 2018
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02375477
Brief Title
Improved Adherence to C. Difficile Isolation Protocols Through Improved Education Methods
Official Title
Improved Adherence to C. Difficile Isolation Protocols Though Improved Inter-disciplinary Educational Methods
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 27, 2015 (Actual)
Primary Completion Date
January 6, 2016 (Actual)
Study Completion Date
January 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection, Clostridium Difficile
Keywords
Clostridium difficile, C. difficile, adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health services research (isolation protocol education)
Arm Type
Experimental
Arm Description
Residents and nurses are given an educational intervention on isolation protocols for diarrhea and enteric pathogens approved by Infection Control and covering their recommendations.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention, Educational
Intervention Description
Given educational presentation
Primary Outcome Measure Information:
Title
Rate of C. difficile infection
Description
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.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Proportion of patients with an isolation order placed concurrently with the order for C. difficile
Description
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.
Time Frame
Up to 1 year
Title
Difference in scores post-test minus pre-test
Description
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.
Time Frame
Baseline to up to 1 year
Title
Retention of information
Description
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.
Time Frame
Up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Nakayama
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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

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