Clinical trial NCT03454009: Kent State University / Price Chopper Employee Wellness Study
Official title: Kent State University / Price Chopper Wellness Promotion Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Infection
Influenza-like Illness
Gastrointestinal Infection
Keywords: multi-modal intervention;
office-based employees
hand hygiene
hand sanitizer
hand sanitizer surface wipes
self-reported infections
absenteeism
presenteeism
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: The Golub Corporation, Price Chopper / Market 32
name: Cascades Tissue Group
First posted: 2018-03-05
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a comprehensive randomized cluster hand-hygiene improvement intervention to reduce: self-reported acute respiratory tract infections (ARI) / influenza-like-illness (ILI) and gastrointestinal (GI) illness, absenteeism, presenteeism; and related behavioral and attitudinal change over a 90 day trial. The Intervention group will receive hand hygiene supplies, and a variety of educational materials, including environmental posters in common areas. The control group will perform their usual hygiene activities and will not receive an intervention.

Identical weekly surveys will be administered to the intervention and control groups to measure self-reported illness, absenteeism, presenteeism, along with behavior and attitudes measured at specified intervals during the study. The intervention and control groups were randomized by work floors before the onset of the enrollment period. It is hypothesized that employees in the intervention group will experience reduced self-reported illness, absenteeism and presenteeism along with improved protective hygiene behaviors and related attitudes, relative to those in the control group over the 90-day trial.

Detailed description: The annual costs of seasonal influenza in the United States have been estimated at $87.1 billion, while costs from the common cold have been estimated at $40 billion. Office employees are at increased risk for contracting communicable disease at work, since they spend nearly half of their waking hours in this setting, work in close proximity with each other, and share equipment. Furthermore, employers in the U.S. have a compelling interest to reduce the spread of infectious disease, because they pay for the direct and indirect costs of absenteeism in employee wages, replacement of staff, reduced quality of services, rising health care premiums, and if self-insured, direct health care expenditures.

Hand hygiene is the single most important action to reduce the transmission of pathogens that result in healthcare acquired infections. Moreover, hand hygiene and respiratory etiquette have been recommended as primary non-pharmaceutical strategies in the early stages of an epidemic before a suitable vaccine is available. While influenza vaccine uptake is the most important recommendation to prevent influenza, the vaccine only protects against 3 or 4 of the most prevalent circulating strains in a given flu season and does not provide protection against non-influenza viral and bacterial pathogens. Meta-analysis has shown that numerous community intervention studies in schools, daycare, and private homes have reduced illness from infectious disease by 21-31%.

Despite the enormous burdens from communicable disease and the importance of the workplace as a setting for the potential spread of infections, to date, only four randomized control trials have been performed world-wide among office-based employees to assess the efficacy of hand hygiene interventions to reduce the spread of communicable disease, including acute respiratory infections (ARI), influenza-like illness (ILI) and gastrointestinal infections. Collectively, these interventions have shown promising results. Hubner and colleagues (2010) found a 65% reduction in the odds of contracting the common cold among workers with improved hand hygiene in a public administrative setting in Germany while Savolainen-Kopra and colleagues (2012) found a reduction in infectious illness among office employees in Finland who participated in a study arm that utilized soap and water and educational training. In the U.S., Stedman-Smith and colleagues (2015) found a 31% significant reduction in self-reported ARI / ILI and gastrointestinal illness combined in a multi-modal hand hygiene pilot randomized cluster trial among office employees at a Midwestern government center. While, Arbogast and colleagues (2016) found a significant reduction in health care claims for communicable infections spread by hand-to-mouth modes of transmissions over a 13-month, multi-component hand hygiene trial which utilized education, hand sanitizer and disinfectant wipes.

This is a comprehensive non-pharmaceutical randomized cluster hygiene improvement intervention to reduce self-reported acute respiratory tract infections (ARIs) / influenza-like-illness (ILI) and gastrointestinal (GI) illness, absenteeism, and presenteeism over a 90-day trial. The Intervention group will receive hygiene supplies (hand sanitizer, surface disinfectant wipes, tissues) and educational materials in varied mediums, including brief educational videos, and motivational posters hung in common work areas, in addition to hand sanitizer, along with hand sanitizer and surface disinfectant wipes installed in shared work areas. The control group will perform their usual hygiene activities and will not receive an intervention. Predominate pathways for the spread of ARI/ILI and non-foodborne GI infections include: (1) droplets that land on the nose, mouth, or are inhaled from infected persons' who cough, sneeze or talk; or (2) pathogens on hands contaminated from fomites or from touching infected persons, which come in contact with portals of entry including the mouth and nose. This multi-modal intervention is developed to promote improvements in the performance of protective behaviors that will reduce the spread of pathogens for ARI/ILI and GI infections by minimizing exposure from these two common pathways.

Identical weekly surveys will be administered to the intervention and control groups to measure self-reported illness, absenteeism and presenteeism; related behavior and attitudinal beliefs will be included in the surveys at specified longer intervals during the study. A sub-analysis will be performed to determine if those at high-risk for complications resulting in severe morbidity and mortality from infections show a reduction in self-reported infections, absenteeism and presenteeism. The intervention and control groups were randomized by work floors before the onset of the enrollment period.

It is hypothesized that employees in the intervention group will experience reduced self-reported illness, absenteeism and presenteeism along with improved protective hygiene behaviors, and attitudinal beliefs relative to those in the control group over the 90-day trial. Statistical analysis will be performed to determine if a relative reduction in self-reported communicable infections, absenteeism, and presenteeism, along with the improvement of related behaviors and attitudinal beliefs occurred among members in the intervention group relative to the control group over the 90-day trial. Statistical analysis will include the use of multiple imputation to impute missing variables, and the calculation of incidence rate ratios with 95% confidence intervals. Incident rate ratios will be calculated using generalized linear mixed models with a Poisson distribution and a log link function that will be adjusted for potential confounders and intercluster correlation.

Eligibility criteria: Inclusion Criteria:

* At least 18 years or older
* No known allergies to alcohol or surface disinfecting wipes;
* Works at least 30% of office hours at the study host site;
* Consent to receiving emails from Kent State University.

Exclusion Criteria:

* Under 18 years of age;
* Known allergies to alcohol or surface disinfecting wipes;
* Works less than 30% of office hours at the study host site;
* Does not consent to receiving emails from Kent State University.

Primary outcomes:
measure: Reduction in ARI/ILI/GI infections as Self-Reported in Questionnaire
timeFrame: Approximately 90 days
measure: Reduction in Absenteeism as Self-Reported in Questionnaire
timeFrame: Approximately 90 days
measure: Reduction in Presenteeism as Self-Reported in Questionnaire
timeFrame: Approximately 90 days
Secondary outcomes:
measure: Reduction in ARI/ILI/GI Infections among those at Highest Risk for Complications as Self-Reported in Questionnaire
timeFrame: Approximately 90 days
measure: Improvement in Hygiene Behaviors as Self-Reported in Questionnaire
timeFrame: Approximately 90 days
measure: Improvement in Hygiene-Related Attitudinal Beliefs as Self-Reported in Questionnaire
timeFrame: Approximately 90 days
Other outcomes:
Locations:
city: Schenectady
country: United States
facility: The Golub Corporation (Price Chopper / Market 32)
state: New York
Study officials:
affiliation: Kent State University, College of Public Health
name: Maggie Stedman-Smith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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