NCT04706403

Brief Summary

The goal of this study is to develop evidence-based messages that effectively mitigate concerns of people at risk for not being vaccinated against COVID-19, with the ultimate goal of maximizing vaccine uptake in vulnerable populations. The investigators will collect data on COVID-19 disease and vaccine knowledge, beliefs, and intent to be vaccinated from an existing online panel. Results from this data collection will be used to develop effective messages and communication strategies. The investigators will test alternate versions of messages intended to reduce vaccine hesitancy and promote vaccine uptake among vaccine-hesitant individuals. This project will ultimately result in a set of tested, evidence-derived messages about vaccination for COVID-19.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
756

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 12, 2021

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 5, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

20 days

First QC Date

January 5, 2021

Results QC Date

December 20, 2021

Last Update Submit

May 20, 2022

Conditions

Keywords

Covid-19Vaccination

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Became Less Hesitant About the COVID-19 Vaccine After Receiving a Physician Message

    All participants were asked about their intent to be vaccinated against COVID-19 prior to exposure to one of the five physician messages (Response options: Yes, No, Not sure). After participants were randomly assigned to receive one of the five physician messages, reduction in COVID-19 vaccine hesitancy was assessed with the question: "Would you get vaccinated at this visit". Response options included yes, no, not sure. For participants whose initial vaccination intent was "not sure", a response of "yes" on re-assessment was defined as less hesitant. Response of "not sure" or "yes" were defined as less hesitant for participants whose initial vaccination intent was "no".

    Through survey completion, an average of 12 minutes

Study Arms (5)

Message 1

EXPERIMENTAL

Participants were randomized to receive version #1 of 5 different versions of a message from a physician regarding the COVID-19 vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 1, this statement was followed by a participatory-style recommendation ("What do you think?")

Behavioral: Communication from a physician about the COVID-19 Vaccine

Message 2

EXPERIMENTAL

Participants were randomized to receive version #2 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 2, this statement was followed by a comparison of the COVID-19 vaccine to the flu shot and an explicit recommendation ("I recommend that you get it").

Behavioral: Communication from a physician about the COVID-19 Vaccine

Message 3

EXPERIMENTAL

Participants were randomized to receive version #3 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 3, this statement was followed by a statement that millions of people have already received the COVID-19 vaccine and an explicit recommendation ("I recommend that you get it").

Behavioral: Communication from a physician about the COVID-19 Vaccine

Message 4

EXPERIMENTAL

Participants were randomized to receive version #4 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 4, this statement was followed by an acknowledgment of concerns and reassurance that the physician personally reviewed the safety data and an explicit recommendation ("I recommend that you get it").

Behavioral: Communication from a physician about the COVID-19 Vaccine

Message 5

EXPERIMENTAL

Participants were randomized to receive version #5 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 5, this statement was followed by an emphasis on protecting others an explicit recommendation ("I recommend that you get it").

Behavioral: Communication from a physician about the COVID-19 Vaccine

Interventions

Participants who expressed hesitation about getting vaccinated against COVID-19 were randomized to receive one of five different versions of messages from a physician. The messages that participants in each group received varied slightly and systematically. Specific content and wording of these messages were developed to address and mitigate concerns of those at risk for not being vaccinated.

Message 1Message 2Message 3Message 4Message 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (age 18 and over) who are members of an online panel (Prolific). Members of this panel joined the panel specifically to receive invitations to participate in research surveys and similar activities.
  • Able to complete an online survey in English.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meyers Health Care Institute

Worcester, Massachusetts, 01605, United States

Location

Related Publications (6)

  • 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 Dec 15;173(12):964-973. doi: 10.7326/M20-3569. Epub 2020 Sep 4.

    PMID: 32886525BACKGROUND
  • Brewer NT, Chapman GB, Rothman AJ, Leask J, Kempe A. Increasing Vaccination: Putting Psychological Science Into Action. Psychol Sci Public Interest. 2017 Dec;18(3):149-207. doi: 10.1177/1529100618760521.

    PMID: 29611455BACKGROUND
  • Godinho CA, Yardley L, Marcu A, Mowbray F, Beard E, Michie S. Increasing the intent to receive a pandemic influenza vaccination: Testing the impact of theory-based messages. Prev Med. 2016 Aug;89:104-111. doi: 10.1016/j.ypmed.2016.05.025. Epub 2016 May 25.

    PMID: 27235605BACKGROUND
  • Mowbray F, Marcu A, Godinho CA, Michie S, Yardley L. Communicating to increase public uptake of pandemic flu vaccination in the UK: Which messages work? Vaccine. 2016 Jun 14;34(28):3268-74. doi: 10.1016/j.vaccine.2016.05.006. Epub 2016 May 8.

    PMID: 27166824BACKGROUND
  • Nowak GJ, Sheedy K, Bursey K, Smith TM, Basket M. Promoting influenza vaccination: insights from a qualitative meta-analysis of 14 years of influenza-related communications research by U.S. Centers for Disease Control and Prevention (CDC). Vaccine. 2015 Jun 4;33(24):2741-56. doi: 10.1016/j.vaccine.2015.04.064. Epub 2015 Apr 28.

    PMID: 25936726BACKGROUND
  • Redelings MD, Piron J, Smith LV, Chan A, Heinzerling J, Sanchez KM, Bedair D, Ponce M, Kuo T. Knowledge, attitudes, and beliefs about seasonal influenza and H1N1 vaccinations in a low-income, public health clinic population. Vaccine. 2012 Jan 5;30(2):454-8. doi: 10.1016/j.vaccine.2011.10.050. Epub 2011 Oct 30.

    PMID: 22044740BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Limitations and Caveats

Limitations include: (1) Inability to assess whether the impact of physician messages in practice would parallel the impact in the hypothetical scenarios used in this study; (2) The use of an online research platform (prolific.co) may limit generalizability of results.

Results Point of Contact

Title
Dr. Kimberly Fisher
Organization
UMass Chan Medical School

Study Officials

  • Kimberly Fisher, MD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 12, 2021

Study Start

January 12, 2021

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

May 24, 2022

Results First Posted

January 5, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations