(AGENPARL) – BETHESDA (MARYLAND), gio 14 gennaio 2021 1.
Project PREVENT is a test-negative case-control study of health care personnel (HCP) in 16 US academic medical centers with the following primary objectives: (1) to evaluate post-introduction effectiveness of a complete schedule of SARS-CoV-2 vaccine in preventing laboratory-confirmed symptomatic COVID-19 among HCP (primary objective); (2) to estimate the post-introduction effectiveness of SARS-CoV-2 vaccines in preventing severe disease among those with laboratory-confirmed symptomatic COVID-19; (3) to identify differences in vaccine effectiveness by age group and comorbidity categories; (4) to evaluate vaccine effectiveness in various job categories and clinical practice settings; (5) to estimate the comparative effectiveness of different SARS-CoV-2 vaccines or, for vaccines with 2-dose schedules, 1 vs. 2-doses; (6) to compare health care and COVID-19 testing practices of HCP within specific job groups; (7) to describe quarantine, isolation, repeat testing, and return-to-work practices among vaccinated and unvaccinated HCP tested for COVID-19; (8) to identify factors associated with the decision to be vaccinated for SARS-CoV-2; and (9) to evaluate provider behavior changes, use of infection mitigation strategies, and decision-making in response to COVID-19 vaccination. Data will be collected by enrolling 10,000 HCP in participating sites who develop symptoms of COVID-19, and local project teams will verify (1) vaccination status (COVID-19 and influenza), (2) COVID-19 test results, and (3) healthcare utilization by requesting source document medical records. Modules included in this survey include: (1) participant eligibility/screening form; (2) participant baseline enrollment form/baseline participant survey; (3) participant 6-week follow-up form; (4) clinical trial participation form; (5) weekly facility form; (6) health care utilization abstraction/verification form; (7) vaccination abstraction/verification form; and (8) testing abstraction/verification form. In addition to survey data, medical records will be collected and abstracted to verify exposures and outcomes. Surveys are all administered from a central REDCap system across all sites, and participants are sent survey requests by email and text message. Surveys also can be administered by local site coordinators by telephone, as needed (although all data can be collected without telephone communication). The Data Collection Forms link to Data Dictionary Codebooks.
Questions Adapted From: Data collection instruments were adapted from “Emerging Infections Program Tracking of SARS-CoV-2 Infections and Assessing Vaccine Effectiveness among Healthcare Personnel,” a project of the Centers for Disease Control and Prevention (CDC) Emerging Infections Program.
Population: Adult Workers
Time to Complete: Participant form estimates are as follows: Screening/Eligibility Form – 7 minutes; Baseline Survey – 16 minutes; Follow-up Survey – 12 minutes; Clinical Trial Form – 2 minutes
Mode of Administration: Online (e.g., computer-assisted interview)
Administered by: Self Administered
Trained Lay Examiner/Interviewer
Special Considerations: All instruments are designed to be self-administered by electronic survey and upload portals, but some participants may provide data through a guided telephone interview by a trained interviewer.
Language(s): English, Spanish
Sections of the Survey tool:
Baseline Enrollment: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_BaselineEnrollment_1231.pdf;
Clinical Trial: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_ClinicalTrial_1231.pdf;
Follow Up: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_FollowUp_1231.pdf;
Healthcare Abstraction: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_HealthcareAbstraction_1231.pdf;
Testing Verification: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_TestingVerification_1231.pdf;
Vaccine Verification: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_VaccineVerification_1231.pdf;
Weekly Facility: https://disasterinfo.nlm.nih.gov/content/files/PREVENT_WeeklyFacility_1231.pdf
Available Formats: PDF
Contact Information: Contact: Nicholas Mohr, MD, MS Project Leadership: Nicholas Mohr, MD (University of Iowa) and Dave Talan, MD (University of California-Los Angeles) Instrument Development Team: Nicholas Mohr, MD (University of Iowa) Dave Talan, MD (University of California-Los Angeles) Anusha Krishnadasan, PhD (University of California-Los Angeles) Karisa Harland, PhD (University of Iowa) Kelli Wallace, MS (University of Iowa) Karin Hoth, PhD (University of Iowa)
Includes Research Tools: