Pragmatic Return to Effective Dental Infection Control through Triage and Testing (PREDICT): A feasibility study to improve dental office safety

Background The COVID-19 pandemic highlights the need for practitioners to enhance workflows to increase safety and mitigate risk. As dental practice creates a highly aerosolized environment, pre-visit testing for SARS-CoV-2 has the potential to be an effective mitigation strategy to minimize disease transmission in dental offices. The Pragmatic Return to Effective Dental Infection Control through Testing (PREDICT) Feasibility Study examined the potential, logistics, and impact related to laboratory-based PCR viral testing and point-of-care (POC) antigen testing. Methods Dental healthcare workers (DHCWs) and patients in four dental offices within the National Dental Practice-based Research Network participated in this prospective study. In addition to electronic surveys, participants in two offices completed POC testing, while participants in two offices used lab based PCR methods to detect SARS-CoV-2 infection. For this feasibility study, analysis was limited to descriptive measures. Median and interquartile ranges were reported for Likert scale responses and mean and standard deviation for continuous variables Results Forty-one of forty-three consented patients and twenty-eight of twenty-nine DHCWs completed the protocol. Descriptive statistics calculations including median and interquartile ranges revealed (1) saliva, tongue epithelial cells and nasal swabs were the most desirable specimens for testing for groups (2) both LAB and POC protocols took similar amounts of total time to complete the full testing protocol and (3) DHCWs and patients reported feeling more comfortable when both groups were tested. Conclusions This feasibility study suggests that pre-visit SARS-CoV-2 testing can be effectively implemented into dental practice workflows and positively impact perception of safety for DHCWs and patients, though a larger scale, network study is necessary for generalizability of results. As new virulent infectious diseases continue to emerge, preparing dental personnel to employ an entire toolbox of risk mitigation strategies, including testing, may have the potential to decrease dental practice closure time, maintaining continuity of dental care services for patients. Trial registration This trial was registered on ClinicalTrials.gov: NCT05123742.

It was unknown whether infectious disease testing could be effectively implemented within dental practice work ows for both dental healthcare workers (DHCWs) and patients.Furthermore, it was unknown whether DHCWs and/or patients would be amenable to infectious disease testing as an effort to mitigate risk and what the impact of testing would be on perception of safety within the dental o ce.
What are the key feasibility ndings?
Dental o ces could effectively implement infectious disease testing in the dental practice work ows for both staff and patients.Both DHCWs and patients were amenable to both lab-based PCR and in-o ce point-of-care testing (POC) and reported feeling more comfortable being in an o ce in which both DHCWs and patients were tested.Patients would be willing to pay additional fees for testing.
What are the implications of the feasibility ndings for the design of the main study?
In designing the main study, we aim to identify best practices for implementing infectious disease testing as a high impact risk mitigation strategy, which can be employed in future pandemics.We believe this can maximize the safety of DHCWs and patients from novel infections, while reducing o ce closures and workforce exodus.Results of the feasibility study suggests infectious disease testing can be adopted into practice work ows and has a positive impact on perception of safety; however, results may not be generalizable due to the homogeneity of the study participants as the feasibility study was conducted within only four PBRN o ces in the same region.A larger, network study utilizing the six regions of the National Dental Practice-based Research Network would produce more generalizable results as demographics would re ect more geographic, socio-economic, racial, and ethnic diversity.

Background
The emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus) has reminded the world of the dangers humanity faces from novel infections. (1,2) irst identi ed in December 2019 (3) , the SARS-CoV-2 virus upended our day-to-day activities, initially driving many into isolation, causing interruptions in the provision of essential medical and dental care (4)(5)(6)(7)(8)(9)(10) As the disease shifts from pandemic to endemic (11) , SARS-CoV-2 continues to mutate. (12,13) hile initially virulent with high mortality, the virus is less virulent though morbidity and mortality remains high. (14,15) oughout history, the emergence of novel pathogens have changed practice patterns and will continue to challenge and alter current healthcare practice.For example, in the late 1980s, the human immunode ciency virus signi cantly impacted personal protective equipment (PPE) standards. (16,17) (20) Infectious disease testing is one important measure that can potentially curtail interruptions in care.Several months after the start of the pandemic, polymerase chain reaction (PCR) and antigen point-of-care (POC) testing became available. (21)(35) By identifying infected individuals and halting person-to-person contact through testing, both DCHWs and patients can have an increased perception of safety within the dental practice environment. (33,34)  Pragmatic Return to Effective Dental Infection Control through Triage and Testing (PREDICT) Feasibility study (36) was designed to examine the feasibility for implementing two COVID-19 testing strategies [lab-based polymerase chain reaction (PCR) and point-of-care testing (POC)] in dental o ces.
PREDCIT sought to identify advantages and potential barriers for each testing method and evaluate the impact of each strategy on patients '  To determine ease of use of electronic survey instruments for both the DHCWs and patient participants.
Results of this feasibility study provided preliminary data to inform the development of a large networkwide study that seeks to identify key mitigation strategies to prevent SARS-CoV-2 or novel infectious agents that may affect safety in a dental o ce.

Methods
The PREDICT Feasibility Study was conducted within the National Dental Practice-Based Research Network (PBRN).Funded by the National Institute of Dental and Craniofacial Research of the National Institutes of Health, the PBRN consists of over 7,000 dental professionals across the United States who collaborate and conduct practice-based research. (37,38) ithin this rich and diverse network, members are committed to advancing knowledge of dental practice by pursuing pragmatic approaches to answer important clinical questions. (39,40) ractice-based research explores answers to questions in actual practice environments where patient and dental provider preferences and biases in uence decisions and outcomes.

Approach:
The PREDICT Feasibility Study required participation of DHCWs and patients within dental practices.Four clinician investigators in the National Dental PBRN were recruited to participate.Each of the investigators worked within a dental o ce/practice with at least ve DHCWs, each of which had the option to engage in or decline participation.All interested DHCWs in each of the four o ces were consented by a PBRN Research Coordinator.All DHCW and patient participants were selected based on the following inclusion criteria: over 18 years of age, able to understand English, and able to sign consent.Exclusion criteria included individuals who previously participated in a prior COVID-19 testing feasibility study.

Interventions:
There were two testing groups for DHCWs and patients: POC and LAB.Two o ces were designated as LAB o ces implementing the LAB protocol (PCR testing) for DHCWs and patients, while two o ces were designated as POC o ces testing the POC protocol.In total, four protocols were developed.Figure 1a illustrates the LAB and POC protocols for DHCWs and Fig. 1b illustrates the LAB and POC protocols for patients.
DHCW -LAB protocol: DHCWs were consented by the PBRN Research Coordinator.On day 1 (startof-study), DHCW participants completed a start-of-study survey, a symptom triage report and collected saliva, tongue epithelium and capillary blood samples which were sent to the lab for processing.Two weeks later, a second symptom triage report was completed and saliva and tongue specimens were collected.Finally, 2 weeks later, a third symptom triage report was completed, saliva, tongue epithelium cells and capillary blood sample collected along with completion of an end-ofstudy survey and study feasibly survey.SARS-CoV-2 test results along with antibody IgG and IgM results were made available to the PBRN investigator for sharing with dental o ce personnel as soon as available from the viral and antibody processing laboratories.DHCW -POC Protocol: DHCWs are consented by the PBRN Research Coordinator.On day 1 (start-ofstudy), DHCW participants completed a start-of-study survey, a symptom triage report, performed the POC SARS-CoV-2 antigen test, and provided capillary blood samples.Two weeks later, a second symptom triage report was completed and with the POC test repeated.Finally, 2 weeks later, a third symptom triage report was completed, POC test and capillary blood specimen collection repeated along with completion of an end-of-study survey and study feasibly survey.
PATIENT-LAB Protocol: After written informed consent was obtained by a PBRN investigator, patients were asked to complete pre-visit questionnaire and were sent salvia collection kits.One week prior to their visit patients were requested to collect their saliva sample and drop the sample off at their dental o ce, which then forwarded the sample to the lab for analysis.Lab results were forwarded to the PBRN practitioner to inform patient participants prior to their dental visit.The symptom triage report was completed upon reporting for their dental visit.At the completion of their dental visit, a post-visit survey was completed along with a study feasibly questionnaire.
PATIENT-POC Protocol: After written informed consent was performed by a PBRN investigator, patients were asked to complete a pre-visit questionnaire.Upon reporting for their visit, a symptom triage report was completed and the POC SARS-CoV-2 antigen test completed.At the completion of their dental visit, a post-visit survey was completed along with a study feasibly questionnaire.
The Abbott BinaxNOW test SARS-CoV-2 was utilized within POC o ces.A nasal swab specimen was collected and inserted into the Abbott BinaxNOW Covid-19 antigen card to test for nucleocapsid protein antigen, which is used to determine SAR-CoV-2 infection.Conversely, in LAB o ces, saliva and tongue samples were obtained and sent to the University lab for processing.Speci cally, genetic material was extracted from the saliva and tongue epithelium samples via polymerase chain reaction (PCR) test to detect the presence of SARS-CoV-2 RNA, which can indicate present or past SARS-CoV-2 infection.
In addition to testing, questionnaires and surveys were administered to all participants electronically using Research Electronic Data Capture (REDCap), a secure web application, which supports research data collection and operations.For DHCWs, questionnaires at the start and end of the study assessed the impact of regular testing on the perception of safety at two-week intervals.

Outcome Measures and Statistical Analysis
Outcome measures included both process and "effect of intervention" impact measures.Process measures included time required to collect and process specimens, ability to complete the protocol within each window, length of time between obtaining the specimen and obtaining the results and ability to obtain SARS-CoV-2 viral and antigen results prior to start of the dental visit.Effect of intervention outcomes included sense of safety using the numeric rating scale (NRS), if 1) patients are tested, 2) DHCWs are tested and 3) both patients and DHCWs tested.Data related to specimen and test type preferences, willingness and amount to pay and required speci city and sensitivity levels were also collected as responses could signi cantly impact the design of testing protocols in dental o ces.
For this feasibility study, analysis was limited to descriptive measures.Median and interquartile ranges were reported for Likert scale responses and mean and standard deviation for continuous variables.Separate results were reported for DHCWs and patients as protocols differed slightly for the groups (e.g., patients were queried before and after their visit and DHCWS were queried 3 times at 2-week intervals).Comparisons between LAB and POC DHCWs and patients were not performed as the number of participants was limited.Descriptive statistics were calculated using JMP Pro 16 and SAS.

Ethical Considerations:
Human subject protection review was conducted and approved by the University Institutional Review Board.As PBRN investigators were dentists, testing was performed as screening for SARS-CoV-2, not to de nitively diagnose COVID-19.Investigators were encouraged to refer positive patients or DHCWs to their primary care providers.

Study Participants:
Twenty-nine (29) DHCWs and 43 patients were consented (Figure 2), with 28 DCHWs and 41 patients completing the protocol.One DHCW was lost due to a non-COVID-19 related illness.One patient was consented but failed to report for their clinical visit, while another patient did not complete the post-visit surveys.
Participant demographics from the four pilot o ces revealed majority of the DHCW participants were Caucasian (86%) and non-Hispanic (79%).Similarly, patient participants were predominantly Caucasian (88%) and non-Hispanic (84%).The majority of participants lived in suburban surroundings with most DHCWs and patients having a household income of more than $100,000.Mean age of DHCWs was 50 while the mean age of patients was 57.The twenty-nine DHCW participants had varied practice roles with the majority working chairside including twelve (41%) dental assistants, ve (17%) owner dentists, four (14%) associate dentists, ve (17%) dental hygienists.The majority of DHCW (90%) had some college education with twelve (41%) having participated in graduate level education.The majority of patient participants had engaged in college level coursework (30% completing some college, 35% Bachelor's degree, and 21% with a graduate degree).

COVID-19 History and Concern of Contracting COVID-19: (Table 1)
One fourth of DHCWs and patients reported a history of a positive COVID-19 diagnosis prior to participation.(Table 1).Patients reported more household members having been diagnosed with COVID-19 than DHCWs.Almost three quarters of DHCWs reported o ce mates having been diagnosed with COVID-19.Related to vaccinations, 86% of DHCWS and 93% of patients reported having received at least the rst dose of a COVID-19 vaccination.
Related to perceptions of transmissibility within the dental o ce environment, 69% of DHCWs and 63% of patients indicated some degree of concern of contracting COVID-19 from patients in the dental o ce environment.Similarly, 69% of DHCWs and 49% of patients had some degree of concern of contracting COVID-19 from dental o ce personnel, with patients concerned to a lesser extent.

COVID-19 Test Results:
Of the 41 patient participants, two tested positive for SARS-CoV-2 infection: one patient in the POC group (5.0%) and one in the LAB group (4.8%).For the 28 DHCWs who tested three times within a four week period, several DHCWs tested positive for SARS-CoV-2 infection.At both the start and end of the study, there was at least one DHCW identi ed as positive to SARS-CoV-2 through PCR (LAB).At the start of the study, two workers were identi ed as SARS-CoV-2 positive (12.5%) through PCR testing using both saliva and tongue specimens, though both workers were asymptomatic and reported having been diagnosed with COVID-19 several weeks prior.At the end of study, PCR testing results varied by specimen type as PCR testing using tongue epithelial cells identi ed three cases whereas PCR testing using saliva specimens did not for the same individual.

COVID-19 Testing Preferences: (Table 2)
Both DHCWs and patients found venous blood was the least desirable specimen collection method for COVID-19 testing.Saliva, tongue epithelial cells and nasal swabs were rated the most desirable specimens for testing.DHCWs preferred POC testing in the dental o ce.Conversely, patients preferred collecting their specimen at home and mailing the specimen to a lab for processing with POC testing in the dental o ce was slightly less desirable.Dropping off collected specimens at the dental o ce and going to a commercial lab for specimen collection and laboratory processing was the least desirable method.
Overall, both participants reported feeling more comfortable being in an o ce with both DHCWs and patients being tested.Feeling of safety ratings decreased for both groups of participants when testing was limited to DHCWS and decreased even more signi cantly when testing was limited to patients only.When patients were asked if they preferred to go to an o ce where COVID-19 testing was regularly performed, 75% reported a preference to going to an o ce where patients and staff are tested.DHCWs were willing to require patients to pay a median rate of $18 for testing, while patients were willing to pay median rate of $15 to be tested.DHCWs were only willing to pay a median rate of $10 for their own testing.
When asked about minimum levels of sensitivity and speci city, DHCWs reported that tests needed to have a speci city and sensitivity of 85% or higher along with at false positives and false negatives being no greater than 50%.
Screening Process Outcomes: (Table 3) All screening processes, including specimen collection, and preparation and preparing specimens for shipping, and POC processing were considered easy to perform.Saliva specimen collection took longer than nasal POC specimen collection.Both the LAB and POC protocols took similar amounts of total time once all aspects of testing were included (specimen collection, drop off time for PCR testing, and processing time for POC testing).

Discussion
This feasibility study suggests that dental o ces can effectively implement SARS-CoV-2 testing into their work ows.Both dentists and patients reported feeling safer when both dental o ce personnel and patients were regularly tested.In addition, the majority of patient respondents prefer to go to an o ce where patients and staff are regularly tested.This evidence suggests that the implementation of SARS-CoV-2 testing can serve not only as an as effective mitigation strategy to decrease transmission but can positively impact the perception of safety for both DHCWs and patients within the o ce environment.
Results suggest that either testing method, Lab-based PCR or POC COVID-19 testing, can in fact, be built into dental practice work ows, though POC testing has multiple advantages.POC test kits are relatively inexpensive, within the range of willingness to pay, and provide results within 15 minutes.POC testing also has the added bene t of limiting the number of false positives as PCR testing picks up remnant viral particle presence for several months after a patient's course of disease is over.While ease of use, low cost, and reliability make the POC testing favorable, practitioners who avail themselves to pre-visit POC testing should be cognizant, however, of some drawbacks.Limitations include testing administration logistics which require longer patient facing time (sample collection and analysis) and potential added operational costs (physical space and personnel required to enact work ows).The cost-bene t ratio of testing to potential missed appointments or work due to illness must be considered.Overall, in times of high prevalence with high morbidity and mortality, POC testing to mitigate risk of transmission may be an effective strategy to maintain a steady workforce, reduce o ce closures, and avoid disruption in dental care services.
There are several limitations to this study.As the purpose of this study was to develop the methodology for a large-scale PBRN based study, the sample size is small and results are not generalizable.There was limited diversity demographically, geographically and economically within the population tested.In addition, this feasibility study was conducted in an area of the US that is highly vaccinated and potentially more accepting of testing.Conclusions related to testing preference results are also limited as participants may not have been familiar nor had experience with all testing types.Another limitation speci cally related to the logistics of PCR testing.While patients reported a preference for this protocol (specimen collection at-home and mail to lab), the management of this method for the dental o ce proved di cult.Continuity of care was hampered as results were not readily available.Lab processing e ciency impacted the receipt of timely results for patients with pending dental appointments.At the height of the pandemic, study laboratories engaged in PCR analysis had di culty keeping up with demand and results were delayed.For dental providers who wish to implement PCR testing, perhaps a more viable method would be to require patients bear full responsibility for scheduling/ completing testing at a commercial laboratory and reporting results to the dental o ce prior to treatment.Another alternative is to select the in-o ce POC testing method, which eliminates the need for outside processing and analysis.

Conclusions
DHCWs and patients share concern about transmission of COVID-19 in the dental o ce and are receptive to SARS-CoV-2 testing as a mitigation strategy.It is feasible to implement SARS-CoV-2 testing in dental practice work ows.While the SARS-CoV-2 virus is now less virulent, SARS-CoV-2 point-of-care (POC) testing can be used as a model to investigate how dental practices can best prepare for the future.Future studies could contribute to the creation of standard testing practices for dental o ces that can be adopted during times of high incidence of COVID-19, as well as, for the next novel virus.
and DHCWs' perceptions of safety in dental o ces.Study aims included: (1) To determine DHCW and Patient willingness to participate, (2) To determine DHCW and Patient willingness/ability to follow thru with triage, testing and survey administration procedures and (3) Start of study questions included demographics, PPE used in the o ce, work practice controls used in the o ce, importance of triage and testing, importance of PPE measures, perceptions of safety and comfort in the workplace, safety culture in the o ce, SARS-CoV-2 testing preferences, dentist's role in SARS-CoV-2 testing, and willingness to test in the o ce.The DHCW End of Study Survey included questions related to the importance of triage and testing, importance of PPE measures, perceptions of safety and comfort in the workplace, safety culture in the o ce, SARSCoV-2 testing preferences, dentist's role in SARS-CoV-2 testing, willingness to test in the o ce, and vaccinations.The DHCW Participation Survey explored perceptions related to study participation including survey and testing logistics.Similarly, patient pre-and post-visit patient questionnaires examined their beliefs and attitudes pre-and post-visit.The Patient Pre-visit Questionnaire investigated perceptions of safety and comfort, reasons for delaying dental care, concerns about returning to dental care, safety precautions valued, importance of triage and testing, and demographics.The Patient End-of-Visit Survey explored perceptions with testing preferences, PPE observed, environmental controls observed, concerns about returning to dental care, safety precautions valued, importance of triage and testing, likelihood of reporting symptoms, dentist's role in COVID-19 testing and vaccinations.The Patient Participation Survey probed perceptions related to study participation including ease of survey and testing logistics.

Figures Figure 1 PREDICT
Figures

Table 2 :
All protocols, informed consents, survey instruments, and recruitment materials were approved by the University Institutional Review Board, Study ID: IRB-300007026.Written consent was obtained electronically in REDCap from all participants.SARS-CoV-2 Testing Preferences for DHCW and Patient Participants

Table 3 Time
Required for Testing by Test