HexapodBooth: COVID-19 Testing Sample Acquisition Throughput and Efficiency

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04532411
Collaborator
(none)
28,948
1
7
4136.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Personal Protective Testing Booth

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
28948 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Evaluation of SARS-CoV-2 Sample Acquisition Efficiency and PPE Usage With and Without the Hexapod Personal Protective Booth
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
Sep 30, 2020

Arms and Interventions

Arm Intervention/Treatment
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
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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Testing Throughput After Hexapod Implementation [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 [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 [Up to 22 weeks]

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

    4. Return on Investment [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 Outcome Measures

    1. Change in Testing Personnel Cost Per Test [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 [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 Outcome Measures

    1. Cost of Additional Consumable Supplies Utilized [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kristian R. Olson, M.D., Director, MGH Springboard Studio, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT04532411
    Other Study ID Numbers:
    • QI Initiative
    First Posted:
    Aug 31, 2020
    Last Update Posted:
    Feb 24, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kristian R. Olson, M.D., Director, MGH Springboard Studio, Massachusetts General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 24, 2021