Clinical trial NCT05123742: PREDICT: A PBRN Feasibility Study on COVID-19 Screening in Dental Practice
Official title: Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT): A PBRN Feasibility Study on COVID-19 Screening in Dental
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Infection
Keywords: dental health care
antibody test
antigen test
dental practice environment
COVID-19 screening
point of care testing
lab-based testing
dental offices
pragmatic design
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: The National Dental Practice-Based Research Network
name: Kaiser Foundation Research Institute
name: University of Alabama at Birmingham
name: University of Rochester
name: University of Illinois at Chicago
First posted: 2021-11-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female dental health care workers and patients who are seen in a Practice-Based Research Network dentist office.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perception of Safety
timeFrame: For DHCW at Day 28 (+/- 14 days), For Patients at their dental visit (day 1)
Secondary outcomes:
measure: Specimen Preference
timeFrame: For DHCWs at Day 28 (+/- 13 days); For patients at the time of their dental visit (Day 1)
measure: Testing Protocol Preference
timeFrame: For DHCWs at Day 28 (+/- 14 days); For Patients at time of their dental visit (Day 1)
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers School of Dental Medicine
state: New Jersey
Study officials:
affiliation: Rutgers School of Dental Medicine
name: Cecile Feldman, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers School of Dental Medicine
name: Janine Fredericks-Younger, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers School of Dental Medicine
name: Modupe Coker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers School of Dental Medicine
name: Daniel Fine, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers School of Dental Medicine
name: Gayathri Subramanian, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: Maria Gennaro, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Cyril Meyerowitz, DDS
role: STUDY_DIRECTOR
affiliation: University of Illinois at Chicago
name: Veerasathpurush Allareddy, PhD
role: STUDY_DIRECTOR
References:
citation: Fredericks-Younger J, Fine DH, Subramanian G, Coker MO, Meyerowitz C, Ragusa P, Allareddy V, McBurnie MA, Funkhouser E, Gennaro ML, Feldman CA. The Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT) Study: Protocol for a Prospective Clinical Study in the National Dental Practice-Based Research Network. JMIR Res Protoc. 2022 Aug 31;11(8):e38386. doi: 10.2196/38386.