Hand Hygiene Randomized Cluster Intervention to Reduce Infections

May 4, 2014 updated by: Maggie Stedman-Smith, Kent State University

The Kent State-Cuyahoga County Health Promotion Study

The purpose of this study is to determine if a simple intervention to improve hand hygiene, consisting of a 3-4 minute training video, on-site posters, and hand hygiene supplies, can reduce respiratory and GI illness among employees.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to determine if a simple random cluster intervention trial to improve hand hygiene, consisting of a 3-4 minute training video, on-site posters, and hand hygiene supplies, can reduce respiratory and GI illness among those in the intervention group compared to the control group. The intervention was performed among employees in a Midwestern public government setting. Employees in the treatment group received a 3-4 minute training video online that was embedded in the baseline survey. Motivational posters from the USDHHS encouraging proper hand hygiene were installed in the workplace, along with hand hygiene supplies. The control group received a program called "Ask Me 3" developed by the National Patient Safety Foundation; the intervention consisted of a 3-4 minute training video to encourage clear communication with their health care providers, a brochure discussing the Ask Me 3 principles of clear communication with health care providers, and a key-ring with the Ask Me 3 communication principles to promote more effective communication with health care providers at visits out side of work. The groups were followed monthly through surveys over the Internet for an average of three months after baseline to determine if a relative reduction in self-reported respiratory / GI infections occurred in the intervention group compared to the control group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
324

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Kent, Ohio, United States, 44242
        • Kent State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All employees in respective departments participating in this study were included in the inclusion criteria

Exclusion Criteria:

  • No employees were excluded if they worked in the participating departments in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hand Hygiene Improvement Intervention
Hand Hygiene Improvement Intervention: Participants receive a 4 minute training video about actions to take to reduce risk of respiratory and GI infections that includes hand hygiene practices, along with educational posters and hand hygiene supplies.
Behavioral: Hand Hygiene Improvement Intervention
Participants received a 4 minute video about protective hand hygiene behaviors and other activities (cough ettiquette, and staying home when ill) to reduce the risk of contracting respiratory tract and GI infections. In addition, motivational posters and hand hygiene supplies were distributed in the work setting.
Placebo Comparator: Ask Me 3
Participants in the control group received a 4 minute training video about the Ask Me 3 program for clearer communication with health care providers, a brochure, and a key chain containing principles for clear communication with health care providers.
Behavioral: Ask Me 3
Participants in the control group received a 4 minute training video about the "Ask Me 3" program to promote effective communication with health care providers, along with an "Ask Me 3" brochure and a key-chain with the "Ask Me 3" principles for effective communication with health care providers.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relative reduction in self-reported respiratory and gastrointestinal infections
Time Frame: prior 30 days as elicited by self-report on four monthly surveys
Monthly surveys elicited information among employees in both the intervention and the control group about self-reported usual hand hygiene practices, symptoms of respiratory and GI infections and missed work days due to these symptoms during the prior 30 days. After the close of the study, statistical analysis was conducted to determine relative reductions in the intervention group compared to the control group regarding: self-reported infections and work days missed due to such infections.
prior 30 days as elicited by self-report on four monthly surveys
Self-reported missed days of work due to symptoms of respiratory and gastrointestinal (GI) infections
Time Frame: Monthly surveys for an average of three months
Monthly surveys were administered over the Internet for an average of three months to determine if a relative reduction occurred in the intervention group compared to the control group in self-reported missed days from work due to symptoms of respiratory or GI infections.
Monthly surveys for an average of three months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported usual daily hand hygiene behaviors
Time Frame: Monthly self-report surveys for an average of three months from baseline
Monthly surveys were administered for an average of three months to determine if a relative improvement from self-reported hand hygiene behaviors was seen in the intervention group compared to the control group, from baseline information.
Monthly self-report surveys for an average of three months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kent State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GoJo Industries, Akron OH
Cuyahoga County Government Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maggie Stedman-Smith, Ph.D., M.P.H., Kent State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13-050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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