Kent State University / Price Chopper Employee Wellness Study

NCT03454009 | Completed

• 1 other identifier: 18-052
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Reduction in ARI/ILI/GI infections as Self-Reported in Questionnaire

  The content in this measurement item has demonstrated acceptable validity and reliability in a previous study from a scale that does not have a formal title, utilized by Stedman-Smith, DuBois and Grey (2012). The scale measures whether or not participants have had self-reported (1) acute respiratory tract / influenza-like infections (ARI/ILI) or (2) gastrointestinal (GI) infections with definitions used from the Centers for Disease Control and Prevention (CDC). Measurements will occur baseline, and once per week for 12 successive weeks until the end of the trial. The number of all self-reported infections during the 3-month trial will be counted, combined and summed in the intervention and the control groups; each sum will be used to compute incidence rates and an incidence rate ratio with a 95% confidence interval (CI).

  Approximately 90 days

• Reduction in Absenteeism as Self-Reported in Questionnaire

  Survey measurements will occur at baseline, and once per week for 12 successive weeks until the end of the trial. The content in this measurement item has demonstrated acceptable validity and reliability in a previous study from a scale that does not have a formal title, utilized by Stedman-Smith, DuBois and Grey (2012). The item contains a 6-point scale from zero days lost (0) to more than 5 days lost (6). The question was slightly adapted to add the response option of missing ½ day of work. The total number of lost work-days will be counted and summed from the 12 weekly surveys in the intervention and control group. Incidence rates and an incidence rate ratio with a 95% confidence interval will be calculated. Person days observed for this measurement will exclude holidays and weekends to match the intent of the survey regarding missed scheduled work-days.

  Approximately 90 days

• Reduction in Presenteeism as Self-Reported in Questionnaire

  Survey measurements will occur at baseline and once per week for 12 successive weeks until the end of the trial. This measurement is based upon 3 items on the Stanford Presenteeism Scale (SPS). Each of the 3 items are measured on a scale of 1-5 points from strongly agree (1 point) to strongly disagree (5 points). The original SPS construct measured these same items from a scale of strongly disagree to strongly agree; we have modified this in order to be consistent with the order of the rest of the questions in our survey, which range from positive to negative responses. The higher the number of points, the greater the degree of presenteeism (symptoms of illness while working). The mean score for presenteeism will be calculated in the intervention and control groups; the mean differences in the two groups will be compared, along with a 95% CI.

  Approximately 90 days

Secondary Outcomes (3)

• Reduction in ARI/ILI/GI Infections among those at Highest Risk for Complications as Self-Reported in Questionnaire

  Approximately 90 days

• Improvement in Hygiene Behaviors as Self-Reported in Questionnaire

  Approximately 90 days

• Improvement in Hygiene-Related Attitudinal Beliefs as Self-Reported in Questionnaire

  Approximately 90 days

Study Arms (2)

Multimodal hygiene intervention

EXPERIMENTAL

Employees will receive hygiene supplies including hand sanitizer, hand sanitizer surface disinfectant wipes and tissues, along with the following educational materials: a 2-minute electronic educational video; weekly 30-second electronic videos; and an educational flyer. Training materials discuss the importance of performing hygiene behaviors to prevent the spread of pathogens, such as, cleaning hands, using tissues to cover one's mouth and nose when coughing or sneezing, and keeping office surfaces clean. In addition, hygiene materials will be placed in common areas frequented by employees in the intervention group that include, educational hygiene posters, free standing hand sanitizer delivery stands, and bottles of hand sanitizer .

Behavioral: Multimodal hygiene intervention

Control

NO INTERVENTION

Employees will complete all surveys but will not have access to additional hygiene products. Will follow usual hygiene behaviors.

Interventions

Multimodal hygiene intervention BEHAVIORAL

hygiene supplies including hand sanitizer, hand sanitizer surface disinfectant wipes and tissues, along with the following educational materials: a 2-minute electronic educational video; weekly 30-second electronic videos; and an educational flyer.

Multimodal hygiene intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kent State University: lead
• The Golub Corporation, Price Chopper / Market 32: collaborator
• Cascades Tissue Group: collaborator

Study Sites (1)

The Golub Corporation (Price Chopper / Market 32)

Schenectady, New York, 12308, United States

Location

Related Publications (13)

• Molinari NA, Ortega-Sanchez IR, Messonnier ML, Thompson WW, Wortley PM, Weintraub E, Bridges CB. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine. 2007 Jun 28;25(27):5086-96. doi: 10.1016/j.vaccine.2007.03.046. Epub 2007 Apr 20.

  PMID: 17544181 BACKGROUND

• Fendrick AM, Monto AS, Nightengale B, Sarnes M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med. 2003 Feb 24;163(4):487-94. doi: 10.1001/archinte.163.4.487.

  PMID: 12588210 BACKGROUND

• Baicker K, Cutler D, Song Z. Workplace wellness programs can generate savings. Health Aff (Millwood). 2010 Feb;29(2):304-11. doi: 10.1377/hlthaff.2009.0626. Epub 2010 Jan 14.

  PMID: 20075081 BACKGROUND

• Boyce JM, Pittet D; Healthcare Infection Control Practices Advisory Committee. Society for Healthcare Epidemiology of America. Association for Professionals in Infection Control. Infectious Diseases Society of America. Hand Hygiene Task Force. Guideline for Hand Hygiene in Health-Care Settings: recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Infect Control Hosp Epidemiol. 2002 Dec;23(12 Suppl):S3-40. doi: 10.1086/503164.

  PMID: 12515399 BACKGROUND

• World Health Organization Writing Group; Bell D, Nicoll A, Fukuda K, Horby P, Monto A, Hayden F, Wylks C, Sanders L, van Tam J. Non-pharmaceutical interventions for pandemic influenza, national and community measures. Emerg Infect Dis. 2006 Jan;12(1):88-94. doi: 10.3201/eid1201.051371.

  PMID: 16494723 BACKGROUND

• Centers for Disease Control and Prevention. Key facts about seasonal flu vaccine. Updated October 30, 2017: https://www.cdc.gov/flu/protect/keyfacts

  BACKGROUND

• Aiello AE, Coulborn RM, Perez V, Larson EL. Effect of hand hygiene on infectious disease risk in the community setting: a meta-analysis. Am J Public Health. 2008 Aug;98(8):1372-81. doi: 10.2105/AJPH.2007.124610. Epub 2008 Jun 12.

  PMID: 18556606 BACKGROUND

• Hubner NO, Hubner C, Wodny M, Kampf G, Kramer A. Effectiveness of alcohol-based hand disinfectants in a public administration: impact on health and work performance related to acute respiratory symptoms and diarrhoea. BMC Infect Dis. 2010 Aug 24;10:250. doi: 10.1186/1471-2334-10-250.

  PMID: 20735818 BACKGROUND

• Savolainen-Kopra C, Haapakoski J, Peltola PA, Ziegler T, Korpela T, Anttila P, Amiryousefi A, Huovinen P, Huvinen M, Noronen H, Riikkala P, Roivainen M, Ruutu P, Teirila J, Vartiainen E, Hovi T. Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial. Trials. 2012 Jan 16;13:10. doi: 10.1186/1745-6215-13-10.

  PMID: 22243622 BACKGROUND

• Stedman-Smith M, DuBois CL, Grey SF, Kingsbury DM, Shakya S, Scofield J, Slenkovich K. Outcomes of a pilot hand hygiene randomized cluster trial to reduce communicable infections among US office-based employees. J Occup Environ Med. 2015 Apr;57(4):374-80. doi: 10.1097/JOM.0000000000000421.

  PMID: 25719534 BACKGROUND

• Arbogast JW, Moore-Schiltz L, Jarvis WR, Harpster-Hagen A, Hughes J, Parker A. Impact of a Comprehensive Workplace Hand Hygiene Program on Employer Health Care Insurance Claims and Costs, Absenteeism, and Employee Perceptions and Practices. J Occup Environ Med. 2016 Jun;58(6):e231-40. doi: 10.1097/JOM.0000000000000738.

  PMID: 27281645 BACKGROUND

• Centers for Disease Control and Prevention. How flu spreads. Updated October 5, 2017: https://www.cdc.gov/flu/about/index.html

  BACKGROUND

• Stedman-Smith M, DuBois CL, Grey SF. Hand hygiene performance and beliefs among public university employees. J Health Psychol. 2015 Oct;20(10):1263-74. doi: 10.1177/1359105313510338. Epub 2013 Nov 20.

  PMID: 24265297 BACKGROUND

Study Officials

• Maggie Stedman-Smith, Ph.D.

  Kent State University, College of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 5, 2018
• Study Start: February 5, 2018
• Primary Completion: May 11, 2018
• Study Completion: May 11, 2018
• Last Updated: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Study data will be available for one year following publication of the results.
• Access Criteria: De-identified data that pertains to published results will be provided to other researchers by written request via email contact to the PI.

Locations

US (1)