PREDICT: A PBRN Feasibility Study on COVID-19 Screening in Dental Practice
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| DHCW Subjects in POC Offices Dental Health Care Workers recruited in point of care offices. |
Diagnostic Test: Testing in POC Offices
Dental Health Care Workers & Patients offered POC testing.
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| Patient Subjects in POC Offices Dental patients recruited in point of care offices. |
Diagnostic Test: Testing in POC Offices
Dental Health Care Workers & Patients offered POC testing.
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| DHCW Subjects in LAB Offices Dental Health Care Workers recruited for lab-based testing. |
Diagnostic Test: Testing in LAB Offices
Dental Health Care Workers & Patient offered Lab-based testing.
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| Patient Subjects in LAB Offices Dental patients recruited for lab-based testing. |
Diagnostic Test: Testing in LAB Offices
Dental Health Care Workers & Patient offered Lab-based testing.
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Outcome Measures
Primary Outcome Measures
- Dental Health Care Worker (DHCW) willingness to participate in the study [Day 1]
Ratio of DHCW consenting to DHCW approached
- Patient willingness to participate in the study [Day 1]
Ratio of patients consenting to patients approached
- DHCW Willingness/Ability to Follow Through with the study with Surveys, Triage, and Testing [Day 28]
Percentage of DHCWs who complete the study
- Patient Willingness/Ability to Follow Through with the study with Surveys, Triage, and Testing [Day 1]
Percentage of patients who complete the study
- DHCW Test Completion [Day 28]
Percent of DHCWs with completed SARS-CoV-2 test completed
- Patient Test Completion [Day 1]
Percent of patients with completed SARS-CoV-2 test completed
- Percentage of activities occurring within the defined window for DHCW [Through study completion (an average of 3 months)]
Percent DHCW subjects with consent performed 29 days or less prior to start-of-study day (day 0); mid-study completed at day 14 +/- 7 days from start-of-study, and end-of-study completed day 28 +/- 14 days from start-of-study.
- Percentage of activities occurring within the defined window for patients [Through study completion (an average of 3 months)]
Percent patient subjects with interest letter sent 21 +/- 14 days prior to visit (day 1), consent completed 14 +/-7 days prior to visit (day 1); PCR biologic sample provided 7 days +/- 5 days prior to visit, and exam results look-up completed 2 +/- 2 days prior of visit.
- DHCW Ease of Complying with Protocol [Day 28]
Questions on a survey asking how easy it was to complete the start-of-study, end-of-study and triage surveys; questions on how understandable the questions were on each type of survey; and questions asking how easy it was to collect, prepare and process the biologic specimen for SARS-CoV-2 testing using a 3 point Likert Scale (easy/understandable, OK, difficult/difficult)
- Patient Easy of Complying with Protocol [Day 1]
Questions on a survey asking how easy it was to complete the pre-visit and post-visit surveys; questions on how understandable the questions were on each type of survey; and questions about how easy it was to collect their specimen using a 3 point Likert scale (Easy/understandable, OK, difficult/not understandable)
- Percentage of surveys completed by DHCW [Through study completion (on average 3 months)]
Percentage of participants with complete Start-of-Study, Triage and End-of-Study surveys completed
- Percentage of surveys completed by patients [Through study completion (on average 3 months)]
Percentage of participants with complete Pre-Visit, Triage and Post-Visit surveys completed
Eligibility Criteria
Criteria
Inclusion Criteria:
A Dental Health Care Worker must meet all of the following criteria to be eligible to participate in the study:
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Be 18 years or older
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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
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Be able to understand the informed consent.
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Provide signed and dated informed consent form
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Be able to understand all instructions for data collection instruments
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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:
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Be 18 years or older
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Be able to understand the informed consent.
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Have a computer or electronic tablet with internet access
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Able to complete consent and questionnaire on a computer or electronic tablet
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Provide signed and dated informed consent form
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Be able to understand all instructions for data collection instruments
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Be willing and able to comply with all study procedures, including having a COVID-19 test performed
Exclusion Criteria:
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Children less than 18 years will not be able to participate.
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Participants would be excluded if they participated in the feasibility study previously conducted at Rutgers University.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rutgers School of Dental Medicine | Newark | New Jersey | United States | 07101 |
Sponsors and Collaborators
- Rutgers, The State University of New Jersey
- National Institute of Dental and Craniofacial Research (NIDCR)
- The National Dental Practice-Based Research Network
- Kaiser Foundation Research Institute
- University of Alabama at Birmingham
- University of Rochester
- University of Illinois at Chicago
Investigators
- Principal Investigator: Cecile Feldman, DMD, Rutgers School of Dental Medicine
- Principal Investigator: Janine Fredericks-Younger, DMD, Rutgers School of Dental Medicine
- Principal Investigator: Modupe Coker, PhD, Rutgers School of Dental Medicine
- Principal Investigator: Daniel Fine, DMD, Rutgers School of Dental Medicine
- Principal Investigator: Gayathri Subramanian, DMD, Rutgers School of Dental Medicine
- Principal Investigator: Maria Gennaro, PhD, Rutgers University
- Study Director: Cyril Meyerowitz, DDS, University of Rochester
- Study Director: Veerasathpurush Allareddy, PhD, University of Illinois at Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro2021000968
- IRB-300007026
- U01DE028727