PREDICT: A PBRN Feasibility Study on COVID-19 Screening in Dental Practice

Study Overview
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Brief Summary
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The study team will conduct a feasibility study to develop and test out procedures for improved triage and COVID-19 testing in dental practices to increase safety and perceptions of the safety of Dental Health Care Workers (DHCW) and their patients. DHCWs in offices with Practice-Based Regional Network (PBRN) members and their patients will be recruited to participate in one of two protocols. The first, point-of-care (POC), will test out procedures for point-of-care SARS-CoV-2 antigen testing in the dental office along with enhanced triage using pulse oximeters. The second, laboratory (LAB), will test out procedures for a saliva-based laboratory SARS-CoV-2 viral test along with enhanced triage. The feasibility of implementing COVID-related testing and enhanced triage procedures in the dental setting will provide preliminary data to inform a larger network-wide study grant application.

Detailed Description
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Data derived from this research would enable dental health care workers to return to work, providing essential oral health care services in the safest possible environment. It will provide patients with confidence that they could resume seeking dental care under optimal conditions that ensure their well-being. The specific aims of this proposal are divided into three parts. The first aim is to apply the Delphi methodology, selecting a facilitator, a panel of experts, defining the problem, addressing the problem with several iterations, and coming to a consensus solution. The second aim is will address the concerns and recommended solutions proposed by the Delphi group and formulated into pragmatic improvements that can be applied to improved practice procedures that can be formulated into testable hypotheses that can be incorporated into a practice strategy for the future of dentistry. Pragmatic and novel methodological changes developed by the investigative team will be presented once again to the Delphi group to gain their approval and/or recommended modifications. Our overarching goal is to test these improved strategies in a pilot study and as such the investigators are looking to incorporate two to three methodological suggestions that can be fit into a pragmatic re-design of best dental practices. Thus, the third aim is designed to test these best dental practice approaches in a pilot study. The goal of the third aim is to evaluate how each of these strategies can be applied to different office settings. The data derived from this approach will be used to provide a sample size calculation for a larger study using the PBRN framework for office participation. The all-encompassing aim of the study is to develop a new way of approaching dental practice that ensures a sense of security and practicality for both patients and health professionals. The hypothesis to be tested derived from these aims relates to the structured development of several methodologies that can be applied to dental practice. These methodologic improvements in dental practice will be based on the most current scientific knowledge that can be applied to ensure safety in a dental office setting. To re-iterate the purpose of this study developed from the three aims proposed is to assess and compare each of the pragmatic models developed such that a sample size calculation can be computed. The pilot study design and the sample size calculation derived from this pilot data will compare two to three pragmatic/innovative modifications in the current practice guidelines and provide an estimate that can utilize the larger PBRN framework to best determine the generalizability of the models chosen for study.

Official Title
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Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT): A PBRN Feasibility Study on COVID-19 Screening in Dental

Conditions
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COVID-19 Infection

Intervention / Treatment
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* Diagnostic Test: COVID-19 Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A Dental Health Care Worker must meet all of the following criteria to be eligible to participate in the study: Be 18 years or older Be a National Dental PBRN member dentist or work in a dental office with a National Dental PBRN member dentist who consents to study participation Be able to understand the informed consent. Provide signed and dated informed consent form Be able to understand all instructions for data collection instruments Be willing and able to comply with all study procedures, including COVID-19 testing, and be available for the duration of the study A Patient must meet all of the following criteria to be eligible to participate in the study: Be 18 years or older Be able to understand the informed consent. Have a computer or electronic tablet with internet access Able to complete consent and questionnaire on a computer or electronic tablet Provide signed and dated informed consent form Be able to understand all instructions for data collection instruments Be willing and able to comply with all study procedures, including having a COVID-19 test performed Exclusion Criteria: Children less than 18 years will not be able to participate. Participants would be excluded if they participated in the feasibility study previously conducted at Rutgers University.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DHCW Subjects<br>Dental Health Care Workers | Diagnostic Test: COVID-19 Testing<br>* Testing for the SARS-CoV-2 virus<br>|
| Patient Subjects<br>Dental patients | Diagnostic Test: COVID-19 Testing<br>* Testing for the SARS-CoV-2 virus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of Safety | Participants perception of safety in the dental office. Outcome measure is a score on a scale from 0 to 100 where 0=has unsafe as one can possibly feel and 100=as safe as one can possibly feel. All participants (DHCW and patients) were asked to indicate how safe they would feel seeking dental care if all dental office workers, but not patients, were regularly tested: how safe they would feel seeking care if all patients, but not dental care workers, were tested prior to their dental appointments; and how safe they would feel seeking dental care if all dental workers were regularly tested AND all patients were tested prior to their dental appointments. | For DHCW at Day 28 (+/- 14 days), For Patients at their dental visit (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specimen Preference | Ranking of the type of specimen participants preferred. Outcome measure is a score on a scale from 1 to 6 where 1=the most preferred specimen type and 6 the least preferred specimen type. Scores could not be used twice providing a ranking of specimen preference. | For DHCWs at Day 28 (+/- 13 days); For patients at the time of their dental visit (Day 1) | 
| Testing Protocol Preference | COVID-19 testing method preferred by subjects. Outcomes measure is a score on a scale where testing protocols are ranking from 1 to 4 with 1 being the most preferred method and 4 is the least preferred method. Score could not be used twice with the scores indicating the subject's testing preference. | For DHCWs at Day 28 (+/- 14 days); For Patients at time of their dental visit (Day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antigen test, dental health care, antibody test, dental practice environment, COVID-19 screening, point of care testing, lab-based testing, dental offices, pragmatic design