NCT02375477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2018

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

February 24, 2015

Last Update Submit

January 29, 2018

Conditions

Keywords

Clostridium difficileC. difficileadherence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    Up to 1 year

  • Difference in scores post-test minus pre-test

    Baseline to up to 1 year

  • Retention of information

    Up to 1 year

Study Arms (1)

Health services research (isolation protocol education)

EXPERIMENTAL

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

Interventions

Given educational presentation

Also known as: Education for Intervention, Intervention, Educational
Health services research (isolation protocol education)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient on the gynecologic oncology service
  • Admitted to Seidman 6th floor of the Seidman Cancer Center
  • Diarrhea or clinical concern for C. difficile infection

You may not qualify if:

  • None
  • Medical Staff Criteria:
  • Any resident or nurse treating a patient meeting the above criteria
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Early Intervention, EducationalEducational StatusMethods

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative Techniques

Study Officials

  • John Nakayama

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 2, 2015

Study Start

January 27, 2015

Primary Completion

January 6, 2016

Study Completion

January 6, 2018

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations