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. 2023 Feb 23;23(1):384.
doi: 10.1186/s12889-023-15266-x.

The CONFIDENT study protocol: a randomized controlled trial comparing two methods to increase long-term care worker confidence in the COVID-19 vaccines

Gabrielle Stevens  1 , Lisa C Johnson  2 , Catherine H Saunders  2 , Peter Schmidt  3 , Ailyn Sierpe  2 , Rachael P Thomeer  2 , N Ruth Little  4 , Matthew Cantrell  5 , Renata W Yen  2 , Jacqueline A Pogue  2 , Timothy Holahan  6 , Danielle C Schubbe  2 , Rachel C Forcino  2 , Branden Fillbrook  7 , Rowena Sheppard  8 , Celeste Wooten  9 , Don Goldmann  10 , A James O'Malley  11 , Eve Dubé  12 , Marie-Anne Durand  2   13   14 , Glyn Elwyn  2
Affiliations

The CONFIDENT study protocol: a randomized controlled trial comparing two methods to increase long-term care worker confidence in the COVID-19 vaccines

Gabrielle Stevens et al. BMC Public Health. .

Abstract

Background: Clinical and real-world effectiveness data for the COVID-19 vaccines have shown that they are the best defense in preventing severe illness and death throughout the pandemic. However, in the US, some groups remain more hesitant than others about receiving COVID-19 vaccines. One important group is long-term care workers (LTCWs), especially because they risk infecting the vulnerable and clinically complex populations they serve. There is a lack of research about how best to increase vaccine confidence, especially in frontline LTCWs and healthcare staff. Our aims are to: (1) compare the impact of two interventions delivered online to enhanced usual practice on LTCW COVID-19 vaccine confidence and other pre-specified secondary outcomes, (2) determine if LTCWs' characteristics and other factors mediate and moderate the interventions' effect on study outcomes, and (3) explore the implementation characteristics, contexts, and processes needed to sustain a wider use of the interventions.

Methods: We will conduct a three-arm randomized controlled effectiveness-implementation hybrid (type 2) trial, with randomization at the participant level. Arm 1 is a dialogue-based webinar intervention facilitated by a LTCW and a medical expert and guided by an evidence-based COVID-19 vaccine decision tool. Arm 2 is a curated social media web application intervention featuring interactive, dynamic content about COVID-19 and relevant vaccines. Arm 3 is enhanced usual practice, which directs participants to online public health information about COVID-19 vaccines. Participants will be recruited via online posts and advertisements, email invitations, and in-person visits to care settings. Trial data will be collected at four time points using online surveys. The primary outcome is COVID-19 vaccine confidence. Secondary outcomes include vaccine uptake, vaccine and booster intent for those unvaccinated, likelihood of recommending vaccination (both initial series and booster), feeling informed about the vaccines, identification of vaccine information and misinformation, and trust in COVID-19 vaccine information provided by different people and organizations. Exploration of intervention implementation will involve interviews with study participants and other stakeholders, an in-depth process evaluation, and testing during a subsequent sustainability phase.

Discussion: Study findings will contribute new knowledge about how to increase COVID-19 vaccine confidence and effective informational modalities for LTCWs.

Trial registration: NCT05168800 at ClinicalTrials.gov, registered December 23, 2021.

Keywords: COVID-19; COVID-19 vaccines; Dialogue-based; Intervention; Long-term care workers; Shared decision-making; Social media; Trial protocol; Vaccine confidence; Vaccine hesitancy.

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Conflict of interest statement

GE and M-A D have developed the Option Grid patient decision aids, which are licensed to EBSCO Health. They receive consulting and royalty income from EBSCO Health. Other authors report no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT diagram Note: Participants must complete T0 to be enrolled in the study. Access to and completion of T2 and T3 follow-up surveys are not dependent on completion of a prior follow-up survey
Fig. 2
Fig. 2
Randomized controlled trial logic model
See this image and copyright information in PMC

References

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