Rutgers Pilot for PREDICT- Patient LAB Test

Study Overview
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Brief Summary
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A pilot study was initiated to assess feasibility of testing asymptomatic dental patients presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2 viral RNA using an FDA approved RT-PCR test for SARS-CoV2- an RNA RT-PCR assay (Accurate Diagnostics)

Detailed Description
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Patients with upcoming dental appointments at the Oral Medicine clinic at Rutgers School of Dental Medicine were contacted to solicit interest in participating in a pilot study to assess feasibility of testing asymptomatic dental patients for SARS CoV 2 infection using an RNA RT-PCR assay. Interested subjects completed a previsit survey after confirming their interest electronically. Subsequently, they received kit to collect their saliva sample at home along with instructions on how to do so. They were directed to drop off their saliva samples for testing at the dental clinic and signed the consent form at that time. After confirming a negative result, the patients were subsequently triaged over the phone for any symptoms and the following day, presented for their dental visit. On the day of their visit, they were triaged, completed their dental visit and were surveyed to get their feedback on the study procedures and their perceptions of safety.

Official Title
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Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Patient LAB Test

Conditions
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SARS-CoV2 Infection

Intervention / Treatment
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* Device: Testing for SARS CoV2 RNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult 18 years or older; reporting to the Rutgers School of Dental Medicine for a dental visit Exclusion Criteria: Previous participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using lab-based RNA RT-PCR testing
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SARS-CoV-2 testing<br>There is only one arm in this study- the study is a non-randomized pilot. All the subjects will be tested for SARS CoV 2 viral infection as described. | Device: Testing for SARS CoV2 RNA<br>* Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Willingness to Participate in the Study | Percentage of 36 patients who were approached to enroll in the study who actually enrolled | Day 1 | 
| Willingness/Ability to Follow Through With the Study With Surveys, Triage and Testing | Percentage of patients who complete the study | 26 days | 
| Patient Test Completion | Percentage of patients with completed SARS-CoV-2 testing | Day 1 | 
| Percentage of Subjects Who Complete Study Activities to Optimize Gap Between Testing and Study Visit | Percentage of subjects completing study activities within the defined optimal window | From initial consent through study completion- approximately 4 weeks | 
| Ease of Complying With Protocol | Number of participants indicating that it was easy to complete the surveys | Day 26 | 
| Percent of Patients Who Completed All of the Required Surveys | Percentage of patients participating in the study who completed pre-visit, triage and post-visit surveys | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Lab-based testing, Asymptomatic patients, Perception of safety, Feasibility