Clinical trial NCT04812184: Adhesive Tape Placement on Patients' Masks in the Emergency Department Increases Compliance of Proper Face Mask Use
Official title: Adhesive Tape Placement on Patients' Masks in the Emergency Department Increases Compliance of Proper Face Mask Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proper Face Mask Use up to 60 Minutes
timeFrame: 60 minutes on Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Nicholas Pettit
role: PRINCIPAL_INVESTIGATOR
References: