Influenza VaccinationNCT05509270
Efficacy of Communication Modalities for Promoting Flu Shots
A study testing Letter, Patient portal and SMS in people with Influenza Vaccination and Health Promotion, run by Geisinger Clinic at 1 site in United States.
Trial summary
The purpose of this study is to test which modalities (mailed letter, short message service [SMS] text, or patient portal messages) are most effective for encouraging flu shots in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza Vaccination, Health Promotion, Health Behavior
- What is being tested?
- Letter, Patient portal and SMS
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43,225 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 4 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Included on a list of active Geisinger patients (all patients on this list attended at least one primary care appointment at Geisinger between 10/1/2008 and 4/13/2022, and either had a Geisinger primary care provider assigned as of April 2022, or were in the Electronic Health Record [EHR] since at least September 2021 and had at least one encounter in 2020-2022)
- Aged 18 or older
- In the top 10% of risk for flu and flu complications, according to Medial's flu complications machine learning algorithm (which operates on coded EHR data)
- Has a Geisinger PCP assigned as of August 2022
- Has had an encounter in the last 2 years as of August 2022
Who cannot join
- Cannot be contacted via any of the communication modalities (e.g., letter, patient portal, SMS) being used in the study, either due to insufficient/missing contact information in the EHR or because they opted out of all modalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Relative Efficacy of Communication Modalities for Messages Promoting Flu Shots
The purpose of this study is to test which modalities (mailed letter, short message service [SMS] text, or patient portal messages) are most effective for encouraging flu shots in high-risk patients.
Read the detailed description
The Centers for Disease Control (CDC) recommends a flu vaccination to everyone aged 6+ months, with rare exception; almost anyone can benefit from the vaccine, which can reduce illnesses, missed work, hospitalizations, and death. Flu shots are particularly important for patients at high risk of experiencing severe outcomes.
During the 2020-21 and 2021-22 flu seasons, the study team sent messages to Geisinger patients in the top 10% of risk for flu and complications according to an artificial intelligence algorithm. Messages that told patients they were at high risk significantly increased their likelihood of getting vaccinated.
The present study will extend previous work by testing which modality or modalities are most effective at boosting flu shot rates in patients at high risk. In previous campaigns, patients received messages via all communication modalities patients were eligible for (mailed letter, SMS text, and/or patient portal message). In this study, patients will be randomized to receive high-risk messages in one or more modalities.
- Being tested
- Letter, Patient portal, SMS
- Keywords
- Flu Vaccine, Choice Architecture, Machine Learning, Perceived Credibility
- Medical subject headings
- Influenza, Human, Health Behavior, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetterBehavioural
Mailed letter about flu vaccination
Patient portalBehavioural
Patient portal message about flu vaccination
SMSBehavioural
SMS about flu vaccination
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No additional pro-vaccination intervention - some patients are currently targeted for flu vaccination messages due to a non-machine learning-based assessment that they are at high risk for complications, but are not told that they are at high risk or that they have been targeted |
| Letter only | Experimental | This group will receive a letter telling them they are at high risk for flu and complications Receives: Behavioral: Letter |
| Patient portal only | Experimental | This group will receive a patient portal message telling them they are at high risk for flu and complications Receives: Behavioral: Patient portal |
| SMS only | Experimental | This group will receive an SMS telling them they are at high risk for flu and complications Receives: Behavioral: SMS |
| Patient portal + SMS | Experimental | This group will receive a patient portal message and an SMS telling them they are at high risk for flu and complications Receives: Behavioral: Patient portal; Behavioral: SMS |
| Letter + Patient portal + SMS | Experimental | This group will receive a letter, a patient portal message, and an SMS telling them they are at high risk for flu and complications Receives: Behavioral: Letter; Behavioral: Patient portal; Behavioral: SMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flu vaccination
Flu vaccination within 4 weeks of the first message send date
Measured: 4 weeks after the first messages are sent in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start6 Sep 2022
- Primary completion4 Oct 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza VaccinationStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 43,225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher F Chabris, PhD, Geisinger Clinic
- Investigators
- Christopher Chabris, PhD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509270
- Sponsor's protocol ID
- 2022-0373
- Status last verified
- Oct 2022
- First submitted
- 18 Aug 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Relative Efficacy of Communication Modalities for Messages Promoting Flu Shots
- ClinicalTrials.gov ID
- NCT05509270
- Acronym / sponsor ID
- 2022-0373
- Keywords
- Flu Vaccine, Choice Architecture, Machine Learning, Perceived Credibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43,225 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test which modalities (mailed letter, short message service [SMS] text, or patient portal messages) are most effective for encouraging flu shots in high-risk patients.
Detailed description
The Centers for Disease Control (CDC) recommends a flu vaccination to everyone aged 6+ months, with rare exception; almost anyone can benefit from the vaccine, which can reduce illnesses, missed work, hospitalizations, and death. Flu shots are particularly important for patients at high risk of experiencing severe outcomes.
During the 2020-21 and 2021-22 flu seasons, the study team sent messages to Geisinger patients in the top 10% of risk for flu and complications according to an artificial intelligence algorithm. Messages that told patients they were at high risk significantly increased their likelihood of getting vaccinated.
The present study will extend previous work by testing which modality or modalities are most effective at boosting flu shot rates in patients at high risk. In previous campaigns, patients received messages via all communication modalities patients were eligible for (mailed letter, SMS text, and/or patient portal message). In this study, patients will be randomized to receive high-risk messages in one or more modalities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No additional pro-vaccination intervention - some patients are currently targeted for flu vaccination messages due to a non-machine learning-based assessment that they are at high risk for complications, but are not told that they are at high risk or that they have been targeted |
| Letter only | Experimental | Behavioral: LetterThis group will receive a letter telling them they are at high risk for flu and complications |
| Patient portal only | Experimental | Behavioral: Patient portalThis group will receive a patient portal message telling them they are at high risk for flu and complications |
| SMS only | Experimental | Behavioral: SMSThis group will receive an SMS telling them they are at high risk for flu and complications |
| Patient portal + SMS | Experimental | Behavioral: Patient portal, Behavioral: SMSThis group will receive a patient portal message and an SMS telling them they are at high risk for flu and complications |
| Letter + Patient portal + SMS | Experimental | Behavioral: Letter, Behavioral: Patient portal, Behavioral: SMSThis group will receive a letter, a patient portal message, and an SMS telling them they are at high risk for flu and complications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Included on a list of active Geisinger patients (all patients on this list attended at least one primary care appointment at Geisinger between 10/1/2008 and 4/13/2022, and either had a Geisinger primary care provider assigned as of April 2022, or were in the Electronic Health Record [EHR] since at least September 2021 and had at least one encounter in 2020-2022)
- Aged 18 or older
- In the top 10% of risk for flu and flu complications, according to Medial's flu complications machine learning algorithm (which operates on coded EHR data)
- Has a Geisinger PCP assigned as of August 2022
- Has had an encounter in the last 2 years as of August 2022
Key exclusion criteria (1 listed)
- Cannot be contacted via any of the communication modalities (e.g., letter, patient portal, SMS) being used in the study, either due to insufficient/missing contact information in the EHR or because they opted out of all modalities
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 |
|---|---|---|
| LetterMailed letter about flu vaccination | Behavioural | Letter + Patient portal + SMS, Letter only |
| Patient portalPatient portal message about flu vaccination | Behavioural | Letter + Patient portal + SMS, Patient portal + SMS, Patient portal only |
| SMSSMS about flu vaccination | Behavioural | Letter + Patient portal + SMS, Patient portal + SMS, SMS only |
Primary outcome
Flu vaccination
Time frame: 4 weeks after the first messages are sent in the study
Flu vaccination within 4 weeks of the first message send date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: Yes. Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.
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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.
Christopher Chabris, PhD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letter, Patient portal and SMS in people with Influenza Vaccination and Health Promotion, run by Geisinger Clinic 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 5 inclusion and 1 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 12 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Flu vaccination (time frame: 4 weeks after the first messages are sent in the study). 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 12 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.