Nudges to Improve Health Behaviors That Limit COVID-19 Spread

Using Behavioral Nudges to Improve Preventive Health Behaviors That Limit COVID-19 Spread

This investigation is a randomized intervention trial that evaluates behavioral nudges (BN) to increase hand washing behavior and subsequently reduce COVID-19 spreading to a targeted high-risk patient population based in Wisconsin.

Study Overview

• Status: Terminated
• Conditions: COVID-19; Health Behavior
• Intervention / Treatment: Behavioral: Nudge

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years or older
• Provision of signed and dated informed consent form
• Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
• Has at least 1 risk factor associated with COVID-19 documented in their electronic medical record
• Followed by (i.e., actively receiving care) from targeted MCW specialties (Internal Medicine, OBGYN, Surgery)
• Access to necessary resources for participating in a technology-based activities (i.e., internet access + mobile phone or computer to complete online survey)
• Maintains a personal address where study materials can be shipped and where participant lives full time

Exclusion Criteria:

• Previous COVID-19 diagnosis or positive COVID-19 test result documented in their electronic medical record
• Current participation in another treatment or intervention study associated with COVID-19
• Previous documented Obsessive-Compulsive Disorder diagnosis in their electronic medical record
• Non-English speaker
• Patients hospitalized or incapacitated at onset of potential enrollment
• No access to electronic platform with internet (e.g., smartphone, tablet, computer)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inertia; Participants simply receive and subsequently have "default" access (i.e., readily and immediately available) to handwashing (HW) materials. This condition will functionally serve as a control comparison. As the term implies, inertia capitalizes on minimizing effort necessary (e.g., going to the grocery store) to engage in HW behavior in one's personal environment.	Behavioral: Nudge; Application of behavior-change strategies based on principles of behavioral economics, decision-making heuristics, psychological/environmental variables.
Experimental: Anchoring; Involves once again providing "default access" to HW materials as above, but adds an explicit written cue to wash hands at a rate of (15) times per day, which is placed directly on the soap dispenser. The stimulus is intended to deliberately prime participant thinking (and subsequent behavior) towards a higher reference point that "overshoots" a desired target rate of 10+ daily HWs.	Behavioral: Nudge; Application of behavior-change strategies based on principles of behavioral economics, decision-making heuristics, psychological/environmental variables.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand Washing Behavior	Measured via adapted version of a previously validated questionnaire (Hygiene Inventory - 23), which specifically includes (a) 1 item about approximate hand washing frequency on an average day, with response options of whole numbers from 0-29 and an additional option of "30 or more" where higher numbers are generally considered better outcomes, (b) 10 items about hand washing behavior in various contexts, with response options of "1 - Never", "2 - Occasionally", "3 - Usually", and "4 - Always" where higher scores are considered better outcomes, and (c) 1 item about general hand hygiene using antibacterial gel or wipes, with response options of "1 - Never", "2 - Occasionally", "3 - Usually", and "4 - Always" where higher scores are considered better outcomes.	8 weeks post-enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcomes - General/Internal Medicine	Patient frequency/rate for the following variables measured via electronic medical record: ED visit (respiratory illness/other) ED visit reason (if non-respiratory) Admission (respiratory Illness) Respiratory Illness secondary to COVID19 ICU admission due to respiratory illness ICU admission due to COVID19 Mechanical Respiratory support Duration of Mechanical support (days) Mortality (respiratory Illness/other)	12 weeks post-enrollment
Clinical Outcomes - Obstetrics & Gynecology	Patient frequency/rate for the following variables measured via electronic medical record: Respiratory Illness at time of Delivery Pre-delivery COVID19 testing Delivery plan altered due to respiratory illness Miscarriage Preterm labor/birth Preeclampsia Respiratory Illness in newborn Newborn COVID19 testing	12 weeks post-enrollment
Clinical Outcomes - Surgery	Patient frequency/rate for the following variables measured via electronic medical record: Respiratory Illness at time of surgery Pre-Operative COVID19 testing Surgery delayed due to respiratory illness Surgery delayed due to COVID19 positive Adverse outcome secondary to delay in surgery Post operative intubation >2 days Post operative unplanned reintubation Post operative pneumonia Post operative respiratory illness secondary to COVID19	12 weeks post-enrollment

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Advancing a Healthier Wisconsin Endowment
• Investigators: Principal Investigator: Nicholas D Young, PhD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00037864

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No