Bacterial InfectionNCT02375477
Improved Adherence to C. Difficile Isolation Protocols Through Improved Education Methods
A study testing Educational Intervention in people with Bacterial Infection and Clostridium Difficile, run by Case Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Infection, Clostridium Difficile
- What is being tested?
- Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2015to 6 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient on the gynecologic oncology service
- Admitted to Seidman 6th floor of the Seidman Cancer Center
- Diarrhea or clinical concern for C. difficile infection
- Any resident or nurse treating a patient meeting the above criteria
Who cannot join
- None
- Medical Staff Criteria:
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To lower rates of C. difficile transmission through improved adherence to recommended isolation protocols.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Bacterial Infection, Clostridium Difficile
- Being tested
- Educational Intervention
- Keywords
- Clostridium difficile, C. difficile, adherence
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention, Educational
Given educational presentation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study start27 Jan 2015
- Primary completion6 Jan 2016
- Study completion6 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John Nakayama, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375477
- Sponsor's protocol ID
- CASE1815
- Other IDs
- NCI-2015-00147, CASE1815, P30CA043703
- Status last verified
- Jan 2018
- First submitted
- 24 Feb 2015
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Adherence to C. Difficile Isolation Protocols Though Improved Inter-disciplinary Educational Methods
- ClinicalTrials.gov ID
- NCT02375477
- Acronym / sponsor ID
- CASE1815
- Conditions
- Bacterial Infection, Clostridium Difficile
- Keywords
- Clostridium difficile, C. difficile, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Jan 2015 (actual)
- Primary completion
- 6 Jan 2016 (actual)
- Study completion
- 6 Jan 2018 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To lower rates of C. difficile transmission through improved adherence to recommended isolation protocols.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (isolation protocol education) | Experimental | Other: Educational InterventionResidents and nurses are given an educational intervention on isolation protocols for diarrhea and enteric pathogens approved by Infection Control and covering their recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient on the gynecologic oncology service
- Admitted to Seidman 6th floor of the Seidman Cancer Center
- Diarrhea or clinical concern for C. difficile infection
- Any resident or nurse treating a patient meeting the above criteria
Key exclusion criteria (3 listed)
- None
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention, EducationalGiven educational presentation | Other | Health services research (isolation protocol education) |
Primary outcome
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.
3 secondary outcomes
Proportion of patients with an isolation order placed concurrently with the order for C. difficile
Time frame: Up to 1 year
Difference in scores post-test minus pre-test
Time frame: Baseline to up to 1 year
Retention of information
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Nakayama principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Bacterial Infection and Clostridium Difficile, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of C. difficile infection (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.