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

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
SARS-CoV Infection; Respiratory Viral Infection; Personal Protective Equipment; Covid19	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
• Estimated Enrollment: 25000 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: March 1, 2020
• Estimated Primary Completion Date: September 30, 2020
• Estimated Study Completion Date: September 30, 2020

Groups and Cohorts

Group/Cohort	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 [ 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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

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

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.

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

More Information

• 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: August 31, 2020
• Last Update Posted: August 31, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

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

• 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., Massachusetts General Hospital:

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

Additional relevant MeSH terms:

Infection; Communicable Diseases; Virus Diseases; Coronavirus Infections; Severe Acute Respiratory Syndrome; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Diseases