COVID-19 Infection
Conditions
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
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.
Interventions
DIAGNOSTIC_TESTCOVID-19 Testing
Testing for the SARS-CoV-2 virus
Sponsors
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
Rutgers, The State University of New Jersey
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perception of Safety | For DHCW at Day 28 (+/- 14 days), For Patients at their dental visit (day 1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Testing Protocol Preference | For DHCWs at Day 28 (+/- 14 days); For Patients at time of their dental visit (Day 1) | 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. |
| Specimen Preference | For DHCWs at Day 28 (+/- 13 days); For patients at the time of their dental visit (Day 1) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dental Healthcare Workers - POC Dental Health Care Workers recruited who work in a participating dental office undergoing point-of-care testing | 13 |
| Dental Healthcare Workers - LAB Dental Health Care Workers recruited who work in a participating dental office undergoing lab based testing | 16 |
| Patient - POC Patients recruited who work in a participating dental office undergoing point-of-care testing | 20 |
| Patients-LAB Patients recruited who work in a participating dental office undergoing lab based testing | 23 |
| Total | 72 |
Baseline characteristics
| Characteristic | Dental Healthcare Workers - POC | Dental Healthcare Workers - LAB | Patient - POC | Patients-LAB | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 3 Participants | 8 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 13 Participants | 17 Participants | 15 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 6 Participants | 0 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 15 Participants | 14 Participants | 22 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 10 Participants | 15 Participants | 18 Participants | 20 Participants | 63 Participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 14 Participants | 13 Participants | 51 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 6 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 15 | 0 / 19 | 0 / 22 |
| other Total, other adverse events | 0 / 13 | 0 / 15 | 0 / 19 | 0 / 22 |
| serious Total, serious adverse events | 0 / 13 | 0 / 15 | 0 / 19 | 0 / 22 |
Outcome results
Primary
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.
Time frame: For DHCW at Day 28 (+/- 14 days), For Patients at their dental visit (day 1)
Population: Only participants who completed the protocol have been included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients-POC | Perception of Safety | Perception of safety when only patients are tested | 60 score on a scale |
| Patients-POC | Perception of Safety | Perception of safety when both patients and DHCW are tested | 100 score on a scale |
| Patients-POC | Perception of Safety | Perception of safety when only DHCW are tested | 95 score on a scale |
| Dental Healthcare Workers - POC | Perception of Safety | Perception of safety when only patients are tested | 74 score on a scale |
| Dental Healthcare Workers - POC | Perception of Safety | Perception of safety when both patients and DHCW are tested | 96 score on a scale |
| Dental Healthcare Workers - POC | Perception of Safety | Perception of safety when only DHCW are tested | 82 score on a scale |
| Dental Healthcare Workers - LAB | Perception of Safety | Perception of safety when only DHCW are tested | 60 score on a scale |
| Dental Healthcare Workers - LAB | Perception of Safety | Perception of safety when only patients are tested | 51 score on a scale |
| Dental Healthcare Workers - LAB | Perception of Safety | Perception of safety when both patients and DHCW are tested | 75 score on a scale |
| Patients - LAB | Perception of Safety | Perception of safety when only patients are tested | 52.5 score on a scale |
| Patients - LAB | Perception of Safety | Perception of safety when both patients and DHCW are tested | 93 score on a scale |
| Patients - LAB | Perception of Safety | Perception of safety when only DHCW are tested | 71 score on a scale |
Secondary
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.
Time frame: For DHCWs at Day 28 (+/- 13 days); For patients at the time of their dental visit (Day 1)
Population: Analysis population is limited to those participants who completed the protocol
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients-POC | Specimen Preference | Saliva | 1 score on a scale |
| Patients-POC | Specimen Preference | Tongue Epithelial Cells | 2 score on a scale |
| Patients-POC | Specimen Preference | Nasal Swab | 2 score on a scale |
| Patients-POC | Specimen Preference | Nasal-Pharyngeal Swab | 4 score on a scale |
| Patients-POC | Specimen Preference | Finger Stick (Capillary Blood) | 5 score on a scale |
| Patients-POC | Specimen Preference | Venous Blood | 6 score on a scale |
| Dental Healthcare Workers - POC | Specimen Preference | Venous Blood | 6 score on a scale |
| Dental Healthcare Workers - POC | Specimen Preference | Nasal-Pharyngeal Swab | 4 score on a scale |
| Dental Healthcare Workers - POC | Specimen Preference | Saliva | 2 score on a scale |
| Dental Healthcare Workers - POC | Specimen Preference | Nasal Swab | 3 score on a scale |
| Dental Healthcare Workers - POC | Specimen Preference | Tongue Epithelial Cells | 2 score on a scale |
| Dental Healthcare Workers - POC | Specimen Preference | Finger Stick (Capillary Blood) | 5 score on a scale |
| Dental Healthcare Workers - LAB | Specimen Preference | Tongue Epithelial Cells | 2 score on a scale |
| Dental Healthcare Workers - LAB | Specimen Preference | Nasal Swab | 1 score on a scale |
| Dental Healthcare Workers - LAB | Specimen Preference | Nasal-Pharyngeal Swab | 6 score on a scale |
| Dental Healthcare Workers - LAB | Specimen Preference | Venous Blood | 6 score on a scale |
| Dental Healthcare Workers - LAB | Specimen Preference | Finger Stick (Capillary Blood) | 5 score on a scale |
| Dental Healthcare Workers - LAB | Specimen Preference | Saliva | 3 score on a scale |
| Patients - LAB | Specimen Preference | Finger Stick (Capillary Blood) | 5 score on a scale |
| Patients - LAB | Specimen Preference | Venous Blood | 6 score on a scale |
| Patients - LAB | Specimen Preference | Tongue Epithelial Cells | 2 score on a scale |
| Patients - LAB | Specimen Preference | Nasal-Pharyngeal Swab | 4 score on a scale |
| Patients - LAB | Specimen Preference | Saliva | 2 score on a scale |
| Patients - LAB | Specimen Preference | Nasal Swab | 2 score on a scale |
Secondary
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.
Time frame: For DHCWs at Day 28 (+/- 14 days); For Patients at time of their dental visit (Day 1)
Population: Only participants who completed the protocol are included in this analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients-POC | Testing Protocol Preference | Specimen collected at home and mailed to the lab for processing | 2 score on a scale |
| Patients-POC | Testing Protocol Preference | Point-of-care test in the dental office | 1 score on a scale |
| Patients-POC | Testing Protocol Preference | Specimen collected in the dnetal office and mail to the lab for processing | 3 score on a scale |
| Patients-POC | Testing Protocol Preference | Specimen collected at a commercial lab and processed at the lab | 4 score on a scale |
| Dental Healthcare Workers - POC | Testing Protocol Preference | Point-of-care test in the dental office | 3 score on a scale |
| Dental Healthcare Workers - POC | Testing Protocol Preference | Specimen collected in the dnetal office and mail to the lab for processing | 2 score on a scale |
| Dental Healthcare Workers - POC | Testing Protocol Preference | Specimen collected at a commercial lab and processed at the lab | 4 score on a scale |
| Dental Healthcare Workers - POC | Testing Protocol Preference | Specimen collected at home and mailed to the lab for processing | 1 score on a scale |
| Dental Healthcare Workers - LAB | Testing Protocol Preference | Specimen collected in the dnetal office and mail to the lab for processing | 3 score on a scale |
| Dental Healthcare Workers - LAB | Testing Protocol Preference | Point-of-care test in the dental office | 2 score on a scale |
| Dental Healthcare Workers - LAB | Testing Protocol Preference | Specimen collected at a commercial lab and processed at the lab | 4 score on a scale |
| Dental Healthcare Workers - LAB | Testing Protocol Preference | Specimen collected at home and mailed to the lab for processing | 2 score on a scale |
| Patients - LAB | Testing Protocol Preference | Specimen collected at a commercial lab and processed at the lab | 4 score on a scale |
| Patients - LAB | Testing Protocol Preference | Point-of-care test in the dental office | 2.5 score on a scale |
| Patients - LAB | Testing Protocol Preference | Specimen collected at home and mailed to the lab for processing | 1 score on a scale |
| Patients - LAB | Testing Protocol Preference | Specimen collected in the dnetal office and mail to the lab for processing | 2 score on a scale |