InfluenzaNCT05493787
Nudging Flu Vaccination by Making it Easy for Patients to Schedule a Flu Shot
A study testing Reminder in people with Influenza, run by Geisinger Clinic at 1 site in United States.
Trial summary
The purpose of this study is to test whether messages that make it easy to schedule a flu shot appointment will increase flu shot rates in patients without an upcoming appointment. The study will also test which message versions and message timing are most effective for increasing flu vaccination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139,503 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2022to 3 Jan 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Included in one or both of the following two base patient lists:
- Geisinger patient portal flu outreach list for Fall 2022
- A list of patients obtained from Geisinger's Phenomics and Clinical Data Core (PACDC). This list will include 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 as of October 2022
- Has had a Geisinger encounter in the last 2 years as of October 2022
- Either of the following, as of October 2022:
Show all 11Show fewer
- Has a Geisinger PCP assigned in the Community Medicine, Pediatrics, or Internal Medicine service line
- In the last 2 years, has completed an appointment in a Geisinger specialty on a list of specialties approved by system leadership for flu shot communications
- Has not received a flu-shot during the 2022-23 flu season as of ~1 week prior to the message date (timeline may be slightly different, depending on data pull logistics), according to the Electronic Health Record (EHR)
- Does not have a scheduled in-person primary care or in-person flu-shot-eligible specialty appointment in the 12 weeks following their assigned message send date, as of ~1 week prior to the message date (timelines may be slightly different, depending on data pull logistics or clinical guidance)
- As of this writing, the team plans to define a flu-shot-eligible specialty appointments as appointments in departments that have historically documented or administered flu vaccine. However, this approach may change slightly based on changing clinical guidance.
Who cannot join
- The CMSL/Marketing list will include patients in Geisinger's 65Forward or Community Care populations. If necessary due to logistical constraints, we may exclude these 65Forward and/or Community Care patients from our study.
- Cannot be contacted via the communication modality being used in the study (e.g., patient portal, SMS), e.g., due to insufficient/missing contact information in the EHR or because they opted out
- Has an allergy to flu vaccines according to any EHR allergy table known to the study team
- Has a health maintenance modifier indicating they are permanently discontinued from receiving a seasonal flu shot
- Is on a list of dismissed patients
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test whether messages that make it easy to schedule a flu shot appointment will increase flu shot rates in patients without an upcoming appointment. The study will also test which message versions and message timing are most effective for increasing flu vaccination.
Read the detailed description
The 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. Past work from the study team focused on encouraging flu shots for patients with upcoming appointments. However, many patients in the health system do not have any appointments during flu season.
Eligible patients without an upcoming appointment will be randomized to a passive control group (no message), an active control group (a basic message stating that the patient can get a flu shot at Geisinger) or one of several other messages informed by behavioral science ("ease", "waiting for you", "protect yourself - rare outcomes", or "protect yourself - frequent outcomes"). Patients will be randomly assigned to one of several message send dates. Messages sent via patient portal, short message service (SMS) text, email, and/or another modality, will include a link redirecting patients to a page where they can self-schedule a flu shot.
- Conditions
- Influenza
- Being tested
- Reminder
- Keywords
- Vaccination, Health promotion, Health behavior, Economics, Behavioral
- Medical subject headings
- Influenza, Human, Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReminderBehavioural
Patient portal, SMS, email, and/or another modality
| Study group | Role | What they receive |
|---|---|---|
| Passive control | No intervention | No message |
| Active control message | Active comparator | A message that simply states that patients can get a flu shot at Geisinger Receives: Behavioral: Reminder |
| Ease message | Experimental | A message emphasizing the ease of scheduling a flu shot at Geisinger Receives: Behavioral: Reminder |
| Waiting for you message | Experimental | A message that states the patient's flu shot is "waiting" for them at Geisinger Receives: Behavioral: Reminder |
| Protect yourself - rare message | Experimental | A message that emphasizes the rare, dangerous outcomes of getting the flu (e.g., hospitalization, pneumonia), and states that a flu shot can offer protection from those outcomes Receives: Behavioral: Reminder |
| Protect yourself - frequent message | Experimental | A message that emphasizes the outcomes that frequently occur in people with the flu (e.g., fever, chills, missing important events), and states that a flu shot can offer protection from those outcomes Receives: Behavioral: Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Self-scheduled a Flu Shot
Patient self-schedules a flu vaccine appointment through the patient portal.
This outcome measures whether the patient schedules an appointment within 4 weeks of the send date, but the appointment can occur more than 4 weeks past the send date.
Measured: Within 4 weeks of message send date
Secondary outcomes (1)
Flu Vaccination
Number of patients who received a flu vaccine
Measured: Within 4 weeks of message send date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start8 Nov 2022
- Primary completion3 Jan 2023
- Study completion3 Jan 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 InfluenzaStudies 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
- None (open label)
- Enrolment
- 139,503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology, National Bureau of Economic Research, Inc.
- Responsible party
- Principal investigator, Christopher F Chabris, PhD, Geisinger Clinic
- Investigators
- Christopher F Chabris, PhD, Principal investigator, Geisinger ClinicMichelle N Meyer, PhD JD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493787
- Sponsor's protocol ID
- 2022-0500
- Status last verified
- Dec 2024
- First submitted
- 2 Aug 2022
- Last updated
- 30 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudging Flu Vaccination by Making it Easy for Patients to Schedule a Flu Shot
- ClinicalTrials.gov ID
- NCT05493787
- Acronym / sponsor ID
- 2022-0500
- Conditions
- Influenza
- Keywords
- Vaccination, Health promotion, Health behavior, Economics, Behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139,503 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology, National Bureau of Economic Research, Inc.
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Posted 2 Dec 2024
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 whether messages that make it easy to schedule a flu shot appointment will increase flu shot rates in patients without an upcoming appointment. The study will also test which message versions and message timing are most effective for increasing flu vaccination.
Detailed description
The 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. Past work from the study team focused on encouraging flu shots for patients with upcoming appointments. However, many patients in the health system do not have any appointments during flu season.
Eligible patients without an upcoming appointment will be randomized to a passive control group (no message), an active control group (a basic message stating that the patient can get a flu shot at Geisinger) or one of several other messages informed by behavioral science ("ease", "waiting for you", "protect yourself - rare outcomes", or "protect yourself - frequent outcomes"). Patients will be randomly assigned to one of several message send dates. Messages sent via patient portal, short message service (SMS) text, email, and/or another modality, will include a link redirecting patients to a page where they can self-schedule a flu shot.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Passive control | No intervention | –No message |
| Active control message | Active comparator | Behavioral: ReminderA message that simply states that patients can get a flu shot at Geisinger |
| Ease message | Experimental | Behavioral: ReminderA message emphasizing the ease of scheduling a flu shot at Geisinger |
| Waiting for you message | Experimental | Behavioral: ReminderA message that states the patient's flu shot is "waiting" for them at Geisinger |
| Protect yourself - rare message | Experimental | Behavioral: ReminderA message that emphasizes the rare, dangerous outcomes of getting the flu (e.g., hospitalization, pneumonia), and states that a flu shot can offer protection from those outcomes |
| Protect yourself - frequent message | Experimental | Behavioral: ReminderA message that emphasizes the outcomes that frequently occur in people with the flu (e.g., fever, chills, missing important events), and states that a flu shot can offer protection from those outcomes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Included in one or both of the following two base patient lists:
- Aged 18 or older as of October 2022
- Has had a Geisinger encounter in the last 2 years as of October 2022
- Either of the following, as of October 2022:
- Has not received a flu-shot during the 2022-23 flu season as of ~1 week prior to the message date (timeline may be slightly different, depending on data pull logistics), according to the Electronic Health Record (EHR)
Key exclusion criteria (5 listed)
- The CMSL/Marketing list will include patients in Geisinger's 65Forward or Community Care populations. If necessary due to logistical constraints, we may exclude these 65Forward and/or Community Care patients from our study.
- Cannot be contacted via the communication modality being used in the study (e.g., patient portal, SMS), e.g., due to insufficient/missing contact information in the EHR or because they opted out
- Has an allergy to flu vaccines according to any EHR allergy table known to the study team
- Has a health maintenance modifier indicating they are permanently discontinued from receiving a seasonal flu shot
- Is on a list of dismissed patients
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 |
|---|---|---|
| ReminderPatient portal, SMS, email, and/or another modality | Behavioural | Active control message, Ease message, Protect yourself - frequent message, Protect yourself - rare message, Waiting for you message |
Primary outcome
Number of Patients Who Self-scheduled a Flu Shot
Time frame: Within 4 weeks of message send date
Patient self-schedules a flu vaccine appointment through the patient portal. This outcome measures whether the patient schedules an appointment within 4 weeks of the send date, but the appointment can occur more than 4 weeks past the send date.
1 secondary outcome
Flu Vaccination
Time frame: Within 4 weeks of message send date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 F Chabris, PhD principal investigator
Geisinger Clinic
Michelle N Meyer, PhD JD 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 Reminder in people with Influenza, 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 11 inclusion and 5 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 30 Dec 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 2 Dec 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?
Number of Patients Who Self-scheduled a Flu Shot (time frame: Within 4 weeks of message send date). 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 30 Dec 2024.