PROmotion of COvid-19 VA(X)ccination in the Emergency Department-PROCOVAXED: study protocol for a cluster randomized controlled trial

Robert M Rodriguez, Kelli O'Laughlin, Stephanie A Eucker, Anna Marie Chang, Kristin L Rising, Graham Nichol, Alena Pauley, Hemal Kanzaria, Alexzandra T Gentsch, Cindy Li, Herbie Duber, Jonathan Butler, Vidya Eswaran, Dave Glidden, Robert M Rodriguez, Kelli O'Laughlin, Stephanie A Eucker, Anna Marie Chang, Kristin L Rising, Graham Nichol, Alena Pauley, Hemal Kanzaria, Alexzandra T Gentsch, Cindy Li, Herbie Duber, Jonathan Butler, Vidya Eswaran, Dave Glidden

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.

Keywords: COVID-19; Randomized controlled trial; Vaccine hesitancy.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Intervention blocks study flow
Fig. 2
Fig. 2
Control period blocks study flow

References

    1. Centers for Disease Control and Prevention. COVID Data Tracker. . Accessed 15 Feb 2022.
    1. Yadegari I, Omidi M, Smith SR. The herd-immunity threshold must be updated for multi-vaccine strategies and multiple variants. Sci Rep. 2021;11(1):22970.
    1. Frederiksen LSF, Zhang Y, Foged C, Thakur A. The long road toward COVID-19 herd immunity: vaccine platform technologies and mass immunization strategies. Front Immunol. 2020;11:1817.
    1. Szilagyi PG, Thomas K, Shah MD, Vizueta N, Cui Y, Vangala S, Kapteyn A. National trends in the US public’s likelihood of getting a COVID-19 vaccine—April 1 to December 8, 2020. JAMA. 2021;325(4):396–398.
    1. Siegler AJ, Luisi N, Hall EW, et al. Trajectory of COVID-19 vaccine hesitancy over time and association of initial vaccine hesitancy with subsequent vaccination. JAMA Netw Open. 2021;4(9):e2126882.
    1. Reiter PL, Pennell ML, Katz ML. Acceptability of a COVID-19 vaccine among adults in the United States: how many people would get vaccinated? Vaccine. 2020;38(42):6500–6507.
    1. Gramlich J, Funk C. Black Americans face higher COVID-19 risks, are more hesitant to trust medical scientists, get vaccinated. . Accessed 4 June 2020.
    1. Fisher KA, Bloomstone SJ, Walder J, Crawford S, Fouayzi H, Mazor KM. Attitudes toward a potential SARS-CoV-2 vaccine: a survey of U.S. adults. Ann Intern Med. 2020;173(12):964–973.
    1. Greiner Safi A, Reyes C, Jesch E, Steinhardt J, Niederdeppe J, Skurka C, Kalaji M, Scolere L, Byrne S. Comparing in person and internet methods to recruit low-SES populations for tobacco control policy research. Soc Sci Med. 2019;242:112597.
    1. McMorris BJ, Petrie RS, Catalano RF, Fleming CB, Haggerty KP, Abbott RD. Use of web and in-person survey modes to gather data from young adults on sex and drug use: an evaluation of cost, time, and survey error based on a randomized mixed-mode design. Eval Rev. 2009;33(2):138–158.
    1. Bonevski B, Randell M, Paul C, Chapman K, Twyman L, Bryant J, Brozek I, Hughes C. Reaching the hard-to-reach: a systematic review of strategies for improving health and medical research with socially disadvantaged groups. BMC Med Res Methodol. 2014;14:42.
    1. Kellermann AL, Hsia RY, Yeh C, Morganti KG. Emergency care: then, now, and next. Health Aff (Millwood). 2013;32(12):2069–2074.
    1. Lane BH, Mallow PJ, Hooker MB, Hooker E. Trends in United States emergency department visits and associated charges from 2010 to 2016. Am J Emerg Med. 2020;38(8):1576–1581.
    1. Agency for Healthcare Research and Quality. Trends in Emergency Department Visits - HCUP Fast Stats. . Accessed 27 Jan 2021.
    1. Weber EJ, Showstack JA, Hunt KA, Colby DC, Callaham ML. Does lack of a usual source of care or health insurance increase the likelihood of an emergency department visit? Results of a national population-based study. Ann Emerg Med. 2005;45(1):4–12.
    1. Centers for Disease Control and Prevention. Health, United States, 2017 – Data Finder. . Accessed 28 Jan 2021.
    1. Walls CA, Rhodes KV, Kennedy JJ. The emergency department as usual source of medical care: estimates from the 1998 National Health Interview Survey. Acad Emerg Med. 2002;9(11):1140–1145.
    1. Arnett MJ, Thorpe RJ, Jr, Gaskin DJ, Bowie JV, LaVeist TA. Race, medical mistrust, and segregation in primary care as usual source of care: findings from the exploring health disparities in integrated communities study. J Urban Health. 2016;93(3):456–467.
    1. Tang N, Stein J, Hsia RY, Maselli JH, Gonzales R. Trends and characteristics of US emergency department visits, 1997-2007. JAMA. 2010;304(6):664–670.
    1. Wilson KM, Klein JD. Adolescents who use the emergency department as their usual source of care. Arch Pediatr Adolesc Med. 2000;154(4):361–365.
    1. Rodriguez RM, Torres JR, Chang AM, Haggins AN, Eucker SA, O'Laughlin KN, Anderson E, Miller DG, Wilkerson RG, Caldwell M, Lim SC, Raja AS, Baumann BM, Graterol J, Eswaran V, Chinnock B, REVVED UP Investigators The rapid evaluation of COVID-19 vaccination in emergency departments for underserved patients study. Ann Emerg Med. 2021;78(4):502–510.
    1. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–191.
    1. Searle SR, McCulloch CE. Generalized, linear and mixed models. 1st ed. Hoboken: Wiley-Interscience; 2001.

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