COVID-19 Testing Sample Acquisition Throughput and Efficiency

NCT04532411 | Completed

• 1 other identifier: QI Initiative
• Study Type: observational
• Target: 28,948
• Locations: 1 country
• Sites: 1

Brief Summary

This QI project seeks to evaluate the relative test sample acquisition throughput, personal protective equipment utilization, and relative operational costs of provider-administered COVID-19 (SARS-CoV-2) nasal samples with and with the use of HEPA-filtered, positive pressure isolation booths.

Conditions

SARS-CoV Infection; Respiratory Viral Infection; Personal Protective Equipment; Covid19

Keywords

SARS-CoV Infection; Test Sample Acquisition; Personal Protective Equipment; Personal Protective Booths; COVID19

Outcome Measures

Primary Outcomes (4)

• Change in Testing Throughput After Hexapod Implementation

  Samples acquired per hour using the Hexapod booth will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.

  Up to 22 weeks

• Change in Isolation Gowns Utilized After Hexapod Utilization

  Gowns utilized per test will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.

  Up to 22 weeks

• Change in Cost per Test After Hexapod Implementation

  The difference in costs of collecting test samples before and after hexapod utilization will be calculated.

  Up to 22 weeks

• Return on Investment

  The retail cost of the Hexapod booth will be divided by the average daily cost differential for testing observed and at maximum volume.

  Up to 22 weeks

Secondary Outcomes (2)

• Change in Testing Personnel Cost Per Test

  Up to 22 weeks

• Change in Cost of Isolation Gowns Utilized

  Up to 22 weeks

Other Outcomes (1)

• Cost of Additional Consumable Supplies Utilized

  Up to 22 weeks

Study Arms (2)

Pre-Booth Testing

This cohort was comprised of samples acquired as a component of outpatient SARS-CoV-2 (COVID-19) testing prior to implementation of the Hexapod personal protective booths.

Post-Booth Testing

This cohort was comprised of samples acquired as a component of outpatient SARS-CoV-2 (COVID-19) testing after implementation of the Hexapod personal protective booths.

Other: Personal Protective Testing Booth

Interventions

Personal Protective Testing Booth OTHER

Health personnel who utilize the Hexapod will remain in the booth and utilize durable gloves attached to ports through a plexiglass wall in order to administer a nasal swab for SARS-CoV-2 (COVID-19) testing. Patient escorts and housekeeping/sanitation staff perform additional tasks outside of the booth such as escorting the patient to the correct testing bay and dropping off testing vials and printed information, collect samples and deposit in the appropriate location after testing is complete, and sanitizing the patient bay before a subsequent patient is tested there.

Also known as: Hexapod, HEPA Filtered Positive Pressure Testing Booth

Post-Booth Testing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatient SARS-CoV-2 PCR nasal swabs tests performed March through September 2020.

You may qualify if:

• All testing performed at designated outpatient SARS-CoV-2 at Massachusetts General Hospital (MGH) testing sites beginning March 2019.

You may not qualify if:

• SARS-CoV-2 tests performed not performed within designated outpatient testing sites at MGH.
• Testing performed within the hospital for Emergency Department or Inpatient visits.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, MGH Springboard Studio

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 31, 2020
• Study Start: March 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 23, 2023

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)