Adhesive Tape Placement on Patients' Masks in the Emergency Department Increases Compliance of Proper Face Mask Use

NCT ID: NCT04812184

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2020-10-30

Brief Summary

Methods 123 patients were enrolled in a randomized controlled trial at Eskenazi Hospital from April 2020 until October 2020. We permitted patients to either use their own mask (due to low resources institutionally) or we provided a surgical/cloth mask (early on relied on donated cloth masks for patients). Patients were randomized to a control (no tape over the mask/nose) or to the intervention (placing tape over the bridge of the nose of the face mask). Patients were evaluated at 30- and 60- minute intervals to assess for proper mask usage.

Detailed Description

Study Design and Setting:

This study is a randomized control trial at Eskenazi Hospital ED from April 2020 until October 2020. Eskenazi Hospital is a busy, urban, academic hospital, level 1 trauma center, in downtown Indianapolis. Here we serve a racially diverse, underserved population, with over 100,000 annual ED visits. This work was approved by the Indiana University Institutional Review Board (protocol #2004425945).

Selection of Participants:

All patients presenting to the ED were screened for enrollment in this study by trained research personnel. All patients are required to wear facial coverings while in the ED, and after screening patients based on the exclusion criteria provided below, patients were offered enrollment in the study. Patients were randomly identified by their bed location in the ED via a random number generator. Patients were excluded from the study for: (1) pregnant; (2) prisoner; (3) not English or Spanish speaking (currently a large cohort of ethnic Latino/Latina/Hispanic are utilizing the ED and we can use interpreters to interpret for enrollment); (4) intoxicated or decompensated psychiatric illness; (5) presenting to the ED with a life-threatening condition; (6) allergic to standard tape and/or tegaderm. Patient consent was obtained if an individual agreed to participate in the study.

Interventions:

All patients included in this study were approached and offered enrollment in a study for addressing PPE. The control arm consisted of no active intervention, with the treatment arm placing standard surgical tape over the bridge of the nose to adhere the top of the mask to the bridge of the nose, thereby creating a physical barrier from removing the mask from the face. Patients were reevaluated at 30 minutes and 60 minutes after enrollment to assess for proper mask compliance.

Measurements: Assuming 50% current compliance, 58 patients per arm were needed to have an 80% power to detect a 25% difference assuming a two-sided chi-square test and alpha = 0.05.

Outcomes:

The primary outcome of this trial is proper mask utilization upon reevaluation at 30 and 60 minutes, with the mask at/under the chin, meanwhile completely covering the mouth and nose). Secondary outcomes of this trial were comparing the primary demographic and visit related covariates on initial screening, including age, sex, race/ethnicity, past medical history, social history, chief complaint, and disposition (admission vs. discharge).

Analysis:

Patient demographics and characteristics were compared between the control and treatment groups. To test for differences between groups, Microsoft excel statistical package was utilized, and the Chi-square test was used for categorical variables and the Wilcoxon test for continuous variables.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgical Tape to bridge of nose

placed a piece of tape to the bridge of the nose, adhering a face mask to the patient's face

Group Type: EXPERIMENTAL

Tape Face Mask

Intervention Type: DEVICE

Adding tape to face mask

Standard of care

Patients given a mask with no intervention to the mask

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tape Face Mask

Adding tape to face mask

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• presenting to the emergency department during the covid-19 pandemic
• older than 18 years of age

Exclusion Criteria

• pregnant
• prisoner
• not english speaking
• not intoxicated or decompensated psychiatric illness
• not critically ill
• not allergic to standard tape and/or tegaderm

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Pettit

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas Pettit

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Eskenazi Hospital

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IUMASKstudy

Identifier Type: -

Identifier Source: org_study_id