Covid19NCT04981392
Trusted Messengers: Intervention to Promote COVID-19 Vaccination
A study testing Primary care text message outreach to unvaccinated patients and resources to support PCPs in people with Covid19 and Vaccination, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The study aims to assess the impact of a multicomponent intervention to support Primary Care Provider (PCP) outreach to promote COVID-19 vaccination among vulnerable patients in and near Worcester, MA via a pragmatic, cluster randomized trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Vaccination
- What is being tested?
- Primary care text message outreach to unvaccinated patients and resources to support PCPs
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,844 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2022to 25 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients seen by a PCP at a participating clinic site within 3-years prior to study start
- Age > / = 18 years
Who cannot join
- Patients who have received at least one dose of a COVID-19 vaccine series prior to the start of the intervention
- Non-Massachusetts residents
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Trusted Messengers: Supporting Physicians in Promoting COVID-19 Vaccination
The study aims to assess the impact of a multicomponent intervention to support Primary Care Provider (PCP) outreach to promote COVID-19 vaccination among vulnerable patients in and near Worcester, MA via a pragmatic, cluster randomized trial.
Read the detailed description
The goal of this study is to increase uptake of the COVID-19 vaccine among vulnerable populations through systematic primary care (PCP or clinic) text message outreach to unvaccinated patients, information provision via a study website, and resources to support PCPs.
The clinical trial will randomize 14 primary care clinics from three health systems in the Worcester, Massachusetts area to intervention or control. Eligible patients seen at a study clinic randomized to the intervention will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination.
Providers at a study clinic randomized to the intervention will be provided resources to support their conversations with unvaccinated patients during the intervention. Resources will include access to the study website, factsheets to share with vaccine hesitant patients, prescription pads to be used to "prescribe' the website, and an electronic "smartphrase" that can automatically add information about the study website and how to schedule a COVID-19 vaccination to patients' After Visit Summary and/or clinic note.
- Conditions
- Covid19, Vaccination
- Being tested
- Primary care text message outreach to unvaccinated patients and resources to support PCPs
- Keywords
- Covid-19, Vaccine Hesitancy, Vaccine Confidence
- Medical subject headings
- COVID-19, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary care text message outreach to unvaccinated patients and resources to support PCPsBehavioural
Patients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination.
Providers: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase").
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Primary care text message outreach to unvaccinated patients and resources to support PCPs Receives: Behavioral: Primary care text message outreach to unvaccinated patients and resources to support PCPs |
| Control Arm | No intervention | Patients will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Vaccination Within 3 Months
The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 3 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR).
Measured: 3 months
Secondary outcomes (1)
COVID-19 Vaccination Within 6 Months
The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 6 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start2 Jun 2022
- Primary completion25 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will be tested using a pragmatic, cluster randomized clinical trial. Randomization will occur at the clinic level. Clinics will be matched by practice setting (Academic, Community, Federally Qualified Health Center) and other characteristics as possible. Within each pair, clinics will be randomly allocated to either the intervention or usual care Arm.
- Masking
- None (open label)
- Enrolment
- 21,844 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Kimberly Fisher, University of Massachusetts, Worcester
- Investigators
- Kimberly A Fisher, M.D, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981392
- Sponsor's protocol ID
- H00023254
- Other IDs
- 1R01MD016883-01
- Status last verified
- Nov 2024
- First submitted
- 26 Jul 2021
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trusted Messengers: Supporting Physicians in Promoting COVID-19 Vaccination
- ClinicalTrials.gov ID
- NCT04981392
- Acronym / sponsor ID
- H00023254
- Conditions
- Covid19, Vaccination
- Keywords
- Covid-19, Vaccine Hesitancy, Vaccine Confidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,844 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to assess the impact of a multicomponent intervention to support Primary Care Provider (PCP) outreach to promote COVID-19 vaccination among vulnerable patients in and near Worcester, MA via a pragmatic, cluster randomized trial.
Detailed description
The goal of this study is to increase uptake of the COVID-19 vaccine among vulnerable populations through systematic primary care (PCP or clinic) text message outreach to unvaccinated patients, information provision via a study website, and resources to support PCPs.
The clinical trial will randomize 14 primary care clinics from three health systems in the Worcester, Massachusetts area to intervention or control. Eligible patients seen at a study clinic randomized to the intervention will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination.
Providers at a study clinic randomized to the intervention will be provided resources to support their conversations with unvaccinated patients during the intervention. Resources will include access to the study website, factsheets to share with vaccine hesitant patients, prescription pads to be used to "prescribe' the website, and an electronic "smartphrase" that can automatically add information about the study website and how to schedule a COVID-19 vaccination to patients' After Visit Summary and/or clinic note.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention will be tested using a pragmatic, cluster randomized clinical trial. Randomization will occur at the clinic level. Clinics will be matched by practice setting (Academic, Community, Federally Qualified Health Center) and other characteristics as possible. Within each pair, clinics will be randomly allocated to either the intervention or usual care Arm.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Primary care text message outreach to unvaccinated patients and resources to support PCPsPrimary care text message outreach to unvaccinated patients and resources to support PCPs |
| Control Arm | No intervention | –Patients will receive usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients seen by a PCP at a participating clinic site within 3-years prior to study start
- Age > / = 18 years
Key exclusion criteria (2 listed)
- Patients who have received at least one dose of a COVID-19 vaccine series prior to the start of the intervention
- Non-Massachusetts residents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary care text message outreach to unvaccinated patients and resources to support PCPsPatients: Eligible patients will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination. Providers: PCPs will receive resources to support their conversations with patients about the COVID-19 vaccines (factsheets, prescription pads, electronic "smartphrase"). | Behavioural | Intervention Arm |
Primary outcome
COVID-19 Vaccination Within 3 Months
Time frame: 3 months
The number of patients in the intervention and control arms who receive at least one dose of a COVID-19 vaccination within 3 months of the last text message being sent will be ascertained via the Electronic Health Record (EHR).
1 secondary outcome
COVID-19 Vaccination Within 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly A Fisher, M.D principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary care text message outreach to unvaccinated patients and resources to support PCPs in people with Covid19 and Vaccination, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Vaccination Within 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.