COVID-19 Testing Sample Acquisition Throughput and Efficiency

Covid19 Clinical Trial

— HexapodBooth  

Official title:

Evaluation of SARS-CoV-2 Sample Acquisition Efficiency and PPE Usage With and Without the Hexapod Personal Protective Booth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04532411
• Other study ID #: QI Initiative
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Beginning in March 2020, the MGH began outpatient testing for COVID-19 (SARS-CoV-2) utilizing a provider-administered nasal swab samples. This was administered with infection control protocols utilizing full PPE protection for health providers who would don and doff gowns and gloves with each sample acquisition. With an aim to decrease PPE usage and increase efficiency, personal protective booths with HEPA-filtered air called "Hexapods" were employed, after infection control approval, within the MGH system beginning on April 16, 2020.

Ambulatory Care Management at MGH systematically monitors testing completed and PPE usage on a weekly basis. Managers in charge of personnel changes shared necessary team structures and median salaries for different personnel involved with sample acquisition. MGH Materials management were able to report on costs related to consumable supplies used during testing.

In this investigation, this routinely collected data and averaged timed sample collection observations were used to compare before and after the Hexapod utilization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28948
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Covid19
• Infections
• Personal Protective Equipment
• Respiratory Viral Infection
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome
• Virus Diseases

Intervention

Other:
• Personal Protective Testing Booth
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost of Additional Consumable Supplies Utilized	The Materials Management costs of durable gloves, sleeves, and filters will be be calculated from the manufacturer's recommended monthly replacements of each per booth.	Up to 22 weeks
Primary	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
Primary	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
Primary	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
Primary	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	Change in Testing Personnel Cost Per Test	The difference in median shift salaries before and after Hexapod implementation will be calculated.	Up to 22 weeks
Secondary	Change in Cost of Isolation Gowns Utilized	Outcome 2 will be utilized to calculate the range of the change in cost of isolation gowns utilized compared to baseline usage for samples acquired before April 16th utilizing actual and quoted costs of gowns to Materials Management at MGH.	Up to 22 weeks