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Completed

NCT Number: NCT04532411

COVID-19 Testing Sample Acquisition Throughput and Efficiency

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.

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Key information

Conditions

SARS-CoV Infection COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Personal Protective Equipment Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Respiratory Viral Infection Severe Acute Respiratory Syndrome Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Hexapod, HEPA Filtered Positive Pressure Testing Booth

Primary outcomes

  1. Change in Testing Throughput After Hexapod Implementation

    Time frame: Up to 22 weeks

    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.

  2. Change in Isolation Gowns Utilized After Hexapod Utilization

    Time frame: Up to 22 weeks

    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.

  3. Change in Cost per Test After Hexapod Implementation

    Time frame: Up to 22 weeks

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

  4. Return on Investment

    Time frame: Up to 22 weeks

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

Secondary outcomes

  1. Change in Testing Personnel Cost Per Test

    Time frame: Up to 22 weeks

    The difference in median shift salaries before and after Hexapod implementation will be calculated.

  2. Change in Cost of Isolation Gowns Utilized

    Time frame: Up to 22 weeks

    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.

Other outcomes

  1. Cost of Additional Consumable Supplies Utilized

    Time frame: Up to 22 weeks

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: HexapodBooth

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 31, 2020
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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