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PROmotion of COvid-19 VA(X)ccination in the Emergency Department-PROCOVAXED: study protocol for a cluster randomized controlled trial.
Rodriguez, Robert M; O'Laughlin, Kelli; Eucker, Stephanie A; Chang, Anna Marie; Rising, Kristin L; Nichol, Graham; Pauley, Alena; Kanzaria, Hemal; Gentsch, Alexzandra T; Li, Cindy; Duber, Herbie; Butler, Jonathan; Eswaran, Vidya; Glidden, Dave.
  • Rodriguez RM; Department of Emergency Medicine, University of California, San Francisco, 1001 Potrero Ave, Bldg 5 Rm 6A, San Francisco, CA, 94110, USA. Robert.rodriguez@ucsf.edu.
  • O'Laughlin K; Department of Emergency Medicine, University of Washington, 325 9th Ave, Seattle, WA, 98104, USA.
  • Eucker SA; Department of Emergency Medicine, Duke University, 2301 Erwin Rd, Durham, NC, 27710, USA.
  • Chang AM; Department of Emergency Medicine, Thomas Jefferson University, 1015 Walnut St, Suite 704, Philadelphia, PA, 19107, USA.
  • Rising KL; Department of Emergency Medicine, Thomas Jefferson University, 1015 Walnut St, Suite 704, Philadelphia, PA, 19107, USA.
  • Nichol G; Department of Emergency Medicine, University of Washington, 325 9th Ave, Seattle, WA, 98104, USA.
  • Pauley A; Department of Emergency Medicine, Duke University, 2301 Erwin Rd, Durham, NC, 27710, USA.
  • Kanzaria H; Department of Emergency Medicine, University of California, San Francisco, 1001 Potrero Ave, Bldg 5 Rm 6A, San Francisco, CA, 94110, USA.
  • Gentsch AT; Department of Emergency Medicine, Thomas Jefferson University, 1015 Walnut St, Suite 704, Philadelphia, PA, 19107, USA.
  • Li C; Department of Emergency Medicine, Duke University, 2301 Erwin Rd, Durham, NC, 27710, USA.
  • Duber H; Department of Emergency Medicine, University of Washington, 325 9th Ave, Seattle, WA, 98104, USA.
  • Butler J; Department of Family and Community Medicine, University of California, San Francisco, 500 Parnassus Ave, San Francisco, CA, 94143, USA.
  • Eswaran V; Department of Emergency Medicine, University of California, San Francisco, 1001 Potrero Ave, Bldg 5 Rm 6A, San Francisco, CA, 94110, USA.
  • Glidden D; Department of Epidemiology & Biostatistics, University of California, San Francisco, 16th St, San Francisco, CA, 94158, USA.
Trials ; 23(1): 332, 2022 Apr 21.
Article in English | MEDLINE | ID: covidwho-2098442
ABSTRACT

BACKGROUND:

We conducted in-depth interviews to characterize reasons for COVID-19 vaccine hesitancy in emergency department (ED) patients and developed messaging platforms that may address their concerns. In this trial, we seek to determine whether provision of these COVID-19 vaccine messaging platforms in EDs will be associated with greater COVID-19 vaccine acceptance and uptake in unvaccinated ED patients.

METHODS:

This is a cluster-randomized controlled trial (RCT) evaluating our COVID-19 vaccine messaging platforms in seven hospital EDs (mix of academic, community, and safety-net EDs) in four US cities. Within each study site, we randomized 30 1-week periods to the intervention and 30 1-week periods to the control. Adult patients who have not received a COVID-19 vaccine are eligible with these exclusions (1) major trauma, intoxication, altered mental status, or critical illness; (2) incarceration; (3) psychiatric chief complaint; and (4) suspicion of acute COVID-19 illness. Participants receive an orally administered Intake survey. During intervention weeks, participants then receive three COVID-19 vaccine messaging platforms (4-min video, one-page informational flyer and a brief, scripted face-to-face message delivered by an ED physician or nurse); patients enrolled during non-intervention weeks do not receive these platforms. Approximately, an hour after intake surveys, participants receive a Vaccine Acceptance survey during which the primary outcome of acceptance of the COVID-19 vaccine in the ED is ascertained. The other primary outcome of receipt of a COVID-19 vaccine within 32 days is ascertained by electronic health record review and phone follow-up. To determine whether provision of vaccine messaging platforms is associated with a 7% increase in vaccine acceptance and uptake, we will need to enroll 1290 patients.

DISCUSSION:

Highlighting the difficulties of trial implementation during the COVID-19 pandemic in acute care settings, our novel trial will lay the groundwork for delivery of public health interventions to vulnerable populations whose only health care access occurs in EDs.

CONCLUSIONS:

Toward addressing vaccine hesitancy in vulnerable populations who seek care in EDs, our cluster-RCT will determine whether implementation of vaccine messaging platforms is associated with greater COVID-19 vaccine acceptance and uptake in unvaccinated ED patients. TRIAL STATUS We began enrollment in December 2021 and expect to continue through 2022. TRIAL REGISTRATION ClinicalTrials.gov NCT05142332 . Registered 02 December 2021.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Topics: Vaccines Limits: Adult / Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06285-x

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Topics: Vaccines Limits: Adult / Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06285-x