COVID-19 Testing Sample Acquisition Throughput and Efficiency (HexapodBooth)

• ClinicalTrials.gov Identifier: NCT04532411
• Recruitment Status: Active, not recruiting
• First Posted: August 31, 2020
• Last Update Posted: August 31, 2020
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Kristian R. Olson, M.D., Massachusetts General Hospital

Tracking Information

• First Submitted Date: August 25, 2020
• First Posted Date: August 31, 2020
• Last Update Posted Date: August 31, 2020
• Actual Study Start Date: March 1, 2020
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 27, 2020)

• 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.
• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 27, 2020)

• 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.
• 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 27, 2020)

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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: COVID-19 Testing Sample Acquisition Throughput and Efficiency
• Official Title: Evaluation of SARS-CoV-2 Sample Acquisition Efficiency and PPE Usage With and Without the Hexapod Personal Protective Booth
• 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.

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 Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Outpatient SARS-CoV-2 PCR nasal swabs tests performed March through September 2020.

Condition

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

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.

Other Names:

• Hexapod
• HEPA Filtered Positive Pressure Testing Booth

Study Groups/Cohorts

• 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.
  Intervention: Other: Personal Protective Testing Booth

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 27, 2020): 25000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2020
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04532411
• Other Study ID Numbers: QI Initiative
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: There is no IPD collected as a part of this investigation.

• Responsible Party: Kristian R. Olson, M.D., Massachusetts General Hospital
• Study Sponsor: Massachusetts General Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Massachusetts General Hospital
• Verification Date: August 2020