SARS-CoV InfectionHexapodBoothNCT04532411
COVID-19 Testing Sample Acquisition Throughput and Efficiency
An observational study of SARS-CoV Infection and Respiratory Viral Infection, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection, Respiratory Viral Infection, Personal Protective Equipment
- What is being tested?
- Personal Protective Testing Booth
- How many people
- 28,948 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Outpatient SARS-CoV-2 PCR nasal swabs tests performed March through September 2020.
Who may be able to join
- All testing performed at designated outpatient SARS-CoV-2 at Massachusetts General Hospital (MGH) testing sites beginning March 2019.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluation of SARS-CoV-2 Sample Acquisition Efficiency and PPE Usage With and Without the Hexapod Personal Protective Booth
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.
Read the 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.
- Being tested
- Personal Protective Testing Booth
- Keywords
- SARS-CoV Infection, Test Sample Acquisition, Personal Protective Equipment, Personal Protective Booths, COVID19
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Protective Testing BoothOther
Also called Hexapod, HEPA Filtered Positive Pressure 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Personal Protective Testing Booth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Testing Throughput After Hexapod Implementation
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.
Measured: Up to 22 weeks
Change in Isolation Gowns Utilized After Hexapod Utilization
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.
Measured: Up to 22 weeks
Change in Cost per Test After Hexapod Implementation
The difference in costs of collecting test samples before and after hexapod utilization will be calculated.
Measured: Up to 22 weeks
Return on Investment
The retail cost of the Hexapod booth will be divided by the average daily cost differential for testing observed and at maximum volume.
Measured: Up to 22 weeks
Secondary outcomes (2)
Change in Testing Personnel Cost Per Test
The difference in median shift salaries before and after Hexapod implementation will be calculated.
Measured: Up to 22 weeks
Change in Cost of Isolation Gowns Utilized
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.
Measured: Up to 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Mar 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 28,948 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristian R. Olson, M.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532411
- Sponsor's protocol ID
- QI Initiative
- Acronym
- HexapodBooth
- Status last verified
- Feb 2021
- First submitted
- 25 Aug 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no IPD collected as a part of this investigation.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SARS-CoV-2 Sample Acquisition Efficiency and PPE Usage With and Without the Hexapod Personal Protective Booth
- ClinicalTrials.gov ID
- NCT04532411
- Acronym / sponsor ID
- HexapodBooth / QI Initiative
- Keywords
- SARS-CoV Infection, Test Sample Acquisition, Personal Protective Equipment, Personal Protective Booths, COVID19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,948 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Personal Protective Testing BoothThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatient SARS-CoV-2 PCR nasal swabs tests performed March through September 2020.
Key inclusion criteria (1 listed)
- All testing performed at designated outpatient SARS-CoV-2 at Massachusetts General Hospital (MGH) testing sites beginning March 2019.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal Protective Testing BoothAlso: Hexapod, HEPA Filtered Positive Pressure Testing BoothHealth 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 | Post-Booth Testing |
Primary outcome
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.
2 secondary outcomes
Change in Testing Personnel Cost Per Test
Time frame: Up to 22 weeks
Change in Cost of Isolation Gowns Utilized
Time frame: Up to 22 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No. There is no IPD collected as a part of this investigation.
Related trials for SARS-CoV Infection
Not yet recruiting
Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
Respiratory Viral Infections, Influenza
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination
SARS-CoV Infection
Active, not recruiting
Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
SARS CoV 2 Infection, Influenza A Virus Infection
RecruitingObservational study
Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence
COVID-19, Corona Virus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV Infection and Respiratory Viral Infection, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Testing Throughput After Hexapod Implementation (time frame: Up to 22 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.