ShinglesNCT06238726
Nudging Patients to Increase Shingles Vaccination
A study testing Reminder in people with Shingles and Vaccination Behavior, run by Geisinger Clinic at 1 site in United States.
Trial summary
The purpose of this study is to test whether messages encouraging patients to ask about a Shingrix vaccine at an upcoming appointment will increase Shingrix vaccination rates. The study will also test which of several message versions is most effective. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Shingles, Vaccination Behavior, Behavior, Health
- 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
- 50,786 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2024to 30 Jun 2025
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50+
- Has not received any doses of the Shingrix vaccine according to the Geisinger EHR
- Has a non-acute in-person Geisinger primary care appointment in a department that stocks Shingrix scheduled with enough time to be randomized
Who cannot join
- 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
- Patient does not have an approved insurance on file for Shingrix outreach for their appointment type or department
- Appointment type or department not approved for outreach by Geisinger leadership at the time of outreach
- While a separate flu vaccination nudge campaign is running (approximately from September through December, 2024), patients will be excluded if they have not received a flu shot in the 2024-25 flu season according to the EHR. Such patients will be eligible for inclusion again as soon as the flu vaccination campaign ends.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test whether messages encouraging patients to ask about a Shingrix vaccine at an upcoming appointment will increase Shingrix vaccination rates. The study will also test which of several message versions is most effective.
Read the detailed description
Shingles is a painful disease caused by reactivation of the varicella zoster (chickenpox) virus. About a third of adults in the US will develop shingles in their lifetime, with the highest prevalence in adults ages 50 and older. Roughly one in ten patients with shingles develops complications that can lead to long-term pain and inflammation). Shingrix, a two-shot vaccine series, is highly effective at preventing shingles and is recommended by the CDC for all adults ages 50 and over.
The present study will test whether sending patients messages encouraging them to ask about Shingrix at an upcoming primary care appointment increases vaccination rate relative to Passive Control (no messages). Additionally, four message arms will vary as a function of risk (message includes or does not include a statement telling patient they are at high risk for shingles because they are age 50+) and facts (message includes or does not include several facts about shingles and Shingrix), with the no-high-risk, no-facts arm designated as the Active Control arm.
Message arms will be crossed with two additional randomized variables: number of messages (2 messages or 3 messages) and cost information (the presence or absence of information about the cost of Shingrix in the final message).
Enrollment timing will vary by insurance group. Enrollment will begin with patients who have a Geisinger Health Plan (GHP) membership that allows them to get Shingrix at no cost (this includes the vast majority of GHP members), because existing data allow the study team to easily identify these patients and inform them about their Shingrix coverage in cost messages. Enrollment for patients who are not GHP members (and the few patients with a GHP plan that is not Shingrix eligible) will begin following the development of an automated internal process that will allow cost messages to include information about patients' individualized Shingrix insurance benefits. Alternatively, if development is delayed approximately 2 months or longer from the launch of enrollment for GHP members, the study team may decide in collaboration with Geisinger leadership to begin enrolling patients without GHP using a generic cost message (e.g., "Most patients can get Shingrix at no cost").
Enrollment for each insurance group (GHP members, non-GHP members) will begin with a 2-week pilot period, with a limited number of new patients (e.g., 100 to 200) enrolled per day in that insurance group (these patients will be randomly selected from the eligible patients). During the pilot period, the study team will communicate frequently with clinical partners to ensure there are no issues before full rollout. If issues arise, the pilot period may be extended. If the pilot period does not result in any changes to outreach, or involves only trivial changes, patients enrolled in the pilot period will be included in analysis. If there are more substantive changes to the outreach following the pilot period, patients enrolled during that period will be excluded from analysis.
Once full rollout occurs, enrollment for each insurance group will last for 1 year. Study enrollment will be complete 1 year following full rollout for non-GHP members.
Anticipated enrollment is at least 50,000.
UPDATE ON 4/15/24: Following a recent review of clinical operational workflows, clinical stakeholders determined that the copays estimated through the automated process will typically not be applicable to non-GHP members. Therefore, in the coming weeks, text messaging to eligible non-GHP members will begin, with a generic cost message for those randomized to be sent a cost message.
UPDATE ON 8/6/24: From September through December 2024, a flu vaccination text message nudge campaign will be running at Geisinger for similar appointments as this shingles vaccination study. Clinical leadership has decided that patients should only receive nudge messages about one vaccine per appointment, and that flu shot messages should be prioritized during flu season. Instead of pausing shingles vaccination messages entirely during the flu campaign, the team will enroll patients in the shingles study if they have already gotten a flu vaccine this flu season according to the EHR. The inclusion criteria are now updated to reflect this change.
The original plan (described above) was to run for one year for each insurance group, as described above, with at least 50,000 patients enrolled during this time. Because there is less certainty that enrollment will reach (or surpass) 50,000 patients during the predefined time frame, the study will end for GHP patients after enrollment reaches 50,000 patients. For non-GHP patients, the study will run for 5 additional weeks before stopping completely, because non-GHP launch occurred 5 weeks after GHP launch. This way, the study length will be the same for both insurance groups.
- Conditions
- Shingles, Vaccination Behavior, Behavior, Health
- Being tested
- Reminder
- Medical subject headings
- Herpes Zoster, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReminderBehavioural
Shingrix messages via SMS, patient portal, email, and/or another modality
| Study group | Role | What they receive |
|---|---|---|
| Passive control | No intervention | Patients in this arm will not be sent any messages. |
| Active control | Active comparator | Patients in this arm will be sent messages encouraging them to ask about Shingrix at their upcoming appointment. Receives: Behavioral: Reminder |
| High risk | Experimental | Patients in this arm will be sent messages informing them that they are at high risk for shingles because they are ages 50+, and encouraging them to ask about Shingrix at their upcoming appointment. Receives: Behavioral: Reminder |
| Multi-fact | Experimental | Patients in this arm will be sent messages with facts about shingles and Shingrix, and encouraging them to ask about Shingrix at their upcoming appointment. Receives: Behavioral: Reminder |
| High risk + multi-fact | Experimental | Patients in this arm will be sent messages informing them that they are at high risk for shingles because they are ages 50+, with additional facts about shingles and Shingrix, and encouraging them to ask about Shingrix at their upcoming appointment. Receives: Behavioral: Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shingrix Vaccination on Appointment Day
Received a first Shingrix vaccination on the appointment date (y/n)
Measured: 3 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start25 Mar 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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 ShinglesStudies 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
- 50,786 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 Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238726
- Sponsor's protocol ID
- 2023-1504
- Status last verified
- Jul 2025
- First submitted
- 25 Jan 2024
- Last updated
- 14 Aug 2026
- 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 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudging Patients to Increase Shingles Vaccination
- ClinicalTrials.gov ID
- NCT06238726
- Acronym / sponsor ID
- 2023-1504
- Conditions
- Shingles, Vaccination Behavior, Behavior, Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50,786 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology, National Bureau of Economic Research, Inc.
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Posted 14 Aug 2026
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 encouraging patients to ask about a Shingrix vaccine at an upcoming appointment will increase Shingrix vaccination rates. The study will also test which of several message versions is most effective.
Detailed description
Shingles is a painful disease caused by reactivation of the varicella zoster (chickenpox) virus. About a third of adults in the US will develop shingles in their lifetime, with the highest prevalence in adults ages 50 and older. Roughly one in ten patients with shingles develops complications that can lead to long-term pain and inflammation). Shingrix, a two-shot vaccine series, is highly effective at preventing shingles and is recommended by the CDC for all adults ages 50 and over.
The present study will test whether sending patients messages encouraging them to ask about Shingrix at an upcoming primary care appointment increases vaccination rate relative to Passive Control (no messages). Additionally, four message arms will vary as a function of risk (message includes or does not include a statement telling patient they are at high risk for shingles because they are age 50+) and facts (message includes or does not include several facts about shingles and Shingrix), with the no-high-risk, no-facts arm designated as the Active Control arm.
Message arms will be crossed with two additional randomized variables: number of messages (2 messages or 3 messages) and cost information (the presence or absence of information about the cost of Shingrix in the final message).
Enrollment timing will vary by insurance group. Enrollment will begin with patients who have a Geisinger Health Plan (GHP) membership that allows them to get Shingrix at no cost (this includes the vast majority of GHP members), because existing data allow the study team to easily identify these patients and inform them about their Shingrix coverage in cost messages. Enrollment for patients who are not GHP members (and the few patients with a GHP plan that is not Shingrix eligible) will begin following the development of an automated internal process that will allow cost messages to include information about patients' individualized Shingrix insurance benefits. Alternatively, if development is delayed approximately 2 months or longer from the launch of enrollment for GHP members, the study team may decide in collaboration with Geisinger leadership to begin enrolling patients without GHP using a generic cost message (e.g., "Most patients can get Shingrix at no cost").
Enrollment for each insurance group (GHP members, non-GHP members) will begin with a 2-week pilot period, with a limited number of new patients (e.g., 100 to 200) enrolled per day in that insurance group (these patients will be randomly selected from the eligible patients). During the pilot period, the study team will communicate frequently with clinical partners to ensure there are no issues before full rollout. If issues arise, the pilot period may be extended. If the pilot period does not result in any changes to outreach, or involves only trivial changes, patients enrolled in the pilot period will be included in analysis. If there are more substantive changes to the outreach following the pilot period, patients enrolled during that period will be excluded from analysis.
Once full rollout occurs, enrollment for each insurance group will last for 1 year. Study enrollment will be complete 1 year following full rollout for non-GHP members.
Anticipated enrollment is at least 50,000.
UPDATE ON 4/15/24: Following a recent review of clinical operational workflows, clinical stakeholders determined that the copays estimated through the automated process will typically not be applicable to non-GHP members. Therefore, in the coming weeks, text messaging to eligible non-GHP members will begin, with a generic cost message for those randomized to be sent a cost message.
UPDATE ON 8/6/24: From September through December 2024, a flu vaccination text message nudge campaign will be running at Geisinger for similar appointments as this shingles vaccination study. Clinical leadership has decided that patients should only receive nudge messages about one vaccine per appointment, and that flu shot messages should be prioritized during flu season. Instead of pausing shingles vaccination messages entirely during the flu campaign, the team will enroll patients in the shingles study if they have already gotten a flu vaccine this flu season according to the EHR. The inclusion criteria are now updated to reflect this change.
The original plan (described above) was to run for one year for each insurance group, as described above, with at least 50,000 patients enrolled during this time. Because there is less certainty that enrollment will reach (or surpass) 50,000 patients during the predefined time frame, the study will end for GHP patients after enrollment reaches 50,000 patients. For non-GHP patients, the study will run for 5 additional weeks before stopping completely, because non-GHP launch occurred 5 weeks after GHP launch. This way, the study length will be the same for both insurance groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Passive control | No intervention | –Patients in this arm will not be sent any messages. |
| Active control | Active comparator | Behavioral: ReminderPatients in this arm will be sent messages encouraging them to ask about Shingrix at their upcoming appointment. |
| High risk | Experimental | Behavioral: ReminderPatients in this arm will be sent messages informing them that they are at high risk for shingles because they are ages 50+, and encouraging them to ask about Shingrix at their upcoming appointment. |
| Multi-fact | Experimental | Behavioral: ReminderPatients in this arm will be sent messages with facts about shingles and Shingrix, and encouraging them to ask about Shingrix at their upcoming appointment. |
| High risk + multi-fact | Experimental | Behavioral: ReminderPatients in this arm will be sent messages informing them that they are at high risk for shingles because they are ages 50+, with additional facts about shingles and Shingrix, and encouraging them to ask about Shingrix at their upcoming appointment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50+
- Has not received any doses of the Shingrix vaccine according to the Geisinger EHR
- Has a non-acute in-person Geisinger primary care appointment in a department that stocks Shingrix scheduled with enough time to be randomized
Key exclusion criteria (4 listed)
- 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
- Patient does not have an approved insurance on file for Shingrix outreach for their appointment type or department
- Appointment type or department not approved for outreach by Geisinger leadership at the time of outreach
- While a separate flu vaccination nudge campaign is running (approximately from September through December, 2024), patients will be excluded if they have not received a flu shot in the 2024-25 flu season according to the EHR. Such patients will be eligible for inclusion again as soon as the flu vaccination campaign ends.
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 |
|---|---|---|
| ReminderShingrix messages via SMS, patient portal, email, and/or another modality | Behavioural | Active control, High risk, High risk + multi-fact, Multi-fact |
Primary outcome
Shingrix Vaccination on Appointment Day
Time frame: 3 days after enrollment
Received a first Shingrix vaccination on the appointment date (y/n)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- 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
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 Shingles and Vaccination Behavior, 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 3 inclusion and 4 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 14 Aug 2026. 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 14 Aug 2026). 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?
Shingrix Vaccination on Appointment Day (time frame: 3 days after enrollment). 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 14 Aug 2026.