Clinical trial NCT04532411: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV Infection
Respiratory Viral Infection
Personal Protective Equipment
Covid19
Keywords: SARS-CoV Infection
Test Sample Acquisition
Personal Protective Equipment
Personal Protective Booths
COVID19
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 28948
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient SARS-CoV-2 PCR nasal swabs tests performed March through September 2020.

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.

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.

Primary outcomes:
measure: Change in Testing Throughput After Hexapod Implementation
timeFrame: Up to 22 weeks
measure: Change in Isolation Gowns Utilized After Hexapod Utilization
timeFrame: Up to 22 weeks
measure: Change in Cost per Test After Hexapod Implementation
timeFrame: Up to 22 weeks
measure: Return on Investment
timeFrame: Up to 22 weeks
Secondary outcomes:
measure: Change in Testing Personnel Cost Per Test
timeFrame: Up to 22 weeks
measure: Change in Cost of Isolation Gowns Utilized
timeFrame: Up to 22 weeks
Other outcomes:
measure: Cost of Additional Consumable Supplies Utilized
timeFrame: Up to 22 weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: