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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-300007026 | Other Identifier | University of Alabama at Birmingham | |
| U01DE028727 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
| The National Dental Practice-Based Research Network | NETWORK |
| Kaiser Foundation Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHCW Subjects | Dental Health Care Workers |
| |
| Patient Subjects | Dental patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Testing | Diagnostic Test | Testing for the SARS-CoV-2 virus |
|
| 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) |
| 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) |
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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:
A Patient must meet all of the following criteria to be eligible to participate in the study:
Exclusion Criteria:
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Male and female dental health care workers and patients who are seen in a Practice-Based Research Network dentist office.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Cyril Meyerowitz, DDS | University of Rochester | Study Director |
| Veerasathpurush Allareddy, PhD | University of Illinois at Chicago | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers School of Dental Medicine | Newark | New Jersey | 07101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38419131 | Derived | Fredericks-Younger J, Feldman CA, Allareddy V, Funkhouser E, McBurnie M, Meyerowitz C, Ragusa P, Chapman-Greene J, Coker M, Fine D, Gennaro ML, Subramanian G. Pragmatic Return to Effective Dental Infection Control through Triage and Testing (PREDICT): an observational, feasibility study to improve dental office safety. Pilot Feasibility Stud. 2024 Feb 28;10(1):44. doi: 10.1186/s40814-024-01471-x. | |
| 37720040 | Derived | Fredericks-Younger J, Feldman C, Allareddy V, Funkhouser E, McBurnie M, Meyerowitz C, Ragusa P, Chapman-Greene J, Coker M, Fine DH, Gennaro ML, Subramanian G. Pragmatic Return to Effective Dental Infection Control through Triage and Testing (PREDICT): A feasibility study to improve dental office safety. Res Sq [Preprint]. 2023 Sep 7:rs.3.rs-3011647. doi: 10.21203/rs.3.rs-3011647/v1. |
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If the COVID test results show that a participant is positive for COVID-19, the study staff will tell the participant the results. The study staff will be required to give the participant's name to the state's Department of Public Health if the participant tests positive because this is the law.
At the end of the study, de-identified data will be provided to the National Coordinating Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | DHCW - POC | Dental Health Care Workers undergoing point of care testing |
| FG001 | DHCW - LAB | Dental Healthcare Workers undergoing laboratory testing |
| FG002 | Patients - POC | Patients undergoing point of care testing |
| FG003 | Patients - LAB | Patients undergoing laboratory based testing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dental Healthcare Workers - POC | Dental Health Care Workers recruited who work in a participating dental office undergoing point-of-care testing |
| BG001 | Dental Healthcare Workers - LAB |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only participants who completed the protocol have been included in the analysis. | Posted | Median | Inter-Quartile Range | score on a scale | For DHCW at Day 28 (+/- 14 days), For Patients at their dental visit (day 1) |
|
For DHCWS - 28 days +/- 14 days: For patients 1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DHCW - POC | Dental healthcare workers participating in the point-of-care protocol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cecile A. Feldman, DMD, MBA | Rutgers School of Dental Medicine | 9739724634 | feldman@sdm.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2021 | Feb 20, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2021 | Sep 1, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| University of Alabama at Birmingham |
| OTHER |
| University of Rochester | OTHER |
| University of Illinois at Chicago | OTHER |
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Biospecimens - saliva sample, tongue swab, nasal swab specimen, and capillary blood sample
| 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) |
| 35944181 | Derived | 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. |
Dental Health Care Workers recruited who work in a participating dental office undergoing lab based testing
| BG002 | Patient - POC | Patients recruited who work in a participating dental office undergoing point-of-care testing |
| BG003 | Patients-LAB | Patients recruited who work in a participating dental office undergoing lab based testing |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Patients participating in study undergoing point of care testing
| OG001 | Dental Healthcare Workers - POC | Dental Healthcare Workers participating in study undergoing point of care testing |
| OG002 | Dental Healthcare Workers - LAB | Dental Healthcare Workers undergoing LAB testing |
| OG003 | Patients - LAB | Patients participating in study undergoing laboratory based testing |
|
|
| 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. | Analysis population is limited to those participants who completed the protocol | Posted | Median | Inter-Quartile Range | score on a scale | For DHCWs at Day 28 (+/- 13 days); For patients at the time of their dental visit (Day 1) |
|
|
|
| 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. | Only participants who completed the protocol are included in this analysis. | Posted | Median | Inter-Quartile Range | score on a scale | For DHCWs at Day 28 (+/- 14 days); For Patients at time of their dental visit (Day 1) |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | DHCW - LAB | Dental healthcare workers participating in the laboratory based protocol | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Patients - POC | Patients participating in the POC protocol | 0 | 19 | 0 | 19 | 0 | 19 |
| EG003 | Patients - LAB | Patients participating in the LAB protocol | 0 | 22 | 0 | 22 | 0 | 22 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Tongue Epithelial Cells |
|
| Nasal Swab |
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| Nasal-Pharyngeal Swab |
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| Finger Stick (Capillary Blood) |
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| Venous Blood |
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| Point-of-care test in the dental office |
|
| Specimen collected in the dnetal office and mail to the lab for processing |
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| Specimen collected at a commercial lab and processed at the lab |
|