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Completed

NCT Number: NCT06566534

Personalized Nudging to Increase Influenza Vaccinations

The purpose of this study is to prospectively test whether personalized, message-based nudges can increase flu vaccination compared with nudges that are not personalized or no nudges.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

About this study

On average, 8% of the US population gets sick from influenza each flu season. Since 2010, the annual disease burden of influenza in the U.S. has included 9-41 million illnesses, 140,000-710,000 hospitalizations, and 12,000-52,000 deaths. The Centers for Disease Control and Prevention (CDC) recommends flu vaccination to everyone aged 6 months and older, with rare exceptions; almost anyone can benefit from the vaccine, which can reduce illnesses, missed work, hospitalizations, and death.

Successful efforts to get patients vaccinated against influenza have included text message reminders timed to precede upcoming flu shot-eligible appointments by up to 3 days. For example, the Roybal-funded flu shot megastudy conducted with Penn Medicine and Geisinger patients assessed the effectiveness of numerous types of messages in increasing vaccination, relative to standard communications by the respective health systems; an average 2.1 percentage point absolute increase (or 5% relative increase) in flu shots occurred due to the messages. Similarly, follow-up analysis of the megastudy using machine learning revealed that interventions differed in relative effectiveness across groups of patients as a function of overlapping covariates (e.g., age, sex, insurance type, and comorbidities). This analysis found that nudges optimally targeted to subgroups who responded most strongly to those nudges in the megastudy would have resulted in up to three times the increases in vaccination observed when simply randomly assigning patients to messages.

The present study aims to prospectively test the efficacy of a patient-facing, message-based nudge via short message service (SMS) texts that is predicted by this retrospective machine learning algorithm to be most effective for them (Personalized Nudge) relative to Passive Control (no messages), Active Control (simple reminder message), and Best Nudge (best performing message from the 2020 megastudy). Patients will be randomized to one of these four arms.

Of the 19 original messages from the megastudy, 12 can be carried out at Geisinger in 2024; the other 7 are either no longer relevant (e.g., those that refer to an ongoing coronavirus pandemic) or cannot be carried out due to a technical limitation (e.g., Geisinger is unable to send pictures, so nudges with pictures are excluded). A treatment assignment tree based on the algorithm described above will be applied to this subset of nudges to generate rules for assigning patients to personalized messages based on observed covariates.

The last patients will be enrolled on December 28th for appointments scheduled on December 31st. At least 90,000 patients are expected to be enrolled.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18+
  • Has not received the 2024 flu vaccine according to the Geisinger electronic health record (EHR) prior to randomization
  • Has a non-acute, flu-shot eligible, in-person Geisinger appointment scheduled with enough time to be randomized
  • Has a Geisinger primary care provider

Exclusion criteria

  • Cannot be contacted by SMS (e.g., due to insufficient/missing contact information in the EHR or because they opted out)
  • Appointment type or department not approved for outreach by Geisinger leadership at the time of outreach
  • 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
  • Shares a phone number with someone who has already been enrolled

Treatment and study plan

Reminder

Behavioral

Flu shot messages via SMS

Primary outcomes

  1. Number of Patients With Flu Shot Receipt Between Enrollment Date and Target Appointment Date

    Time frame: Between the enrollment date and target appointment date (at least 4 days and up to 4 months)

    Our field experiment will be conducted with Geisinger Health patients via SMS messages sent prior to their first flu shot-eligible appointment during the study period, referred to as the "target appointment." The key dependent variable is whether patients receive a flu shot at or before their target appointment (as recorded in their electronic health records).

    If patients cancel or do not show up for their target appointment after they have been randomized to a treatment and then schedule a new appointment during the study period, their new flu-shot eligible appointment becomes the target appointment and the outcome window extends from three days prior to the original appointment through the date of the appointment.

    Patients who miss their target appointment and do not reschedule within the study period will still be included in the analysis. Their outcome window is from three days prior to the original appointment through the date of the original canceled appointment.

Other outcomes

  1. Number of Patients With Flu Shot Receipt On or Before December 31, 2024

    Time frame: Up to 4 months after randomization

    Received a flu shot on or before December 31, 2024

  2. Number of Patients with Flu Shot Receipt Between Enrollment Date and First Eligible Appointment

    Time frame: 4 Days

    Patients received the flu shot at or before their first eligible appointment

  3. Number of Patients with Flu Diagnosis (encounter diagnosis or flu test)

    Time frame: Up to 8 months after randomization

    Patients received a flu diagnosis via encounter diagnosis or flu test between enrollment and April 30, 2025.

  4. Number of Patients with Flu-related Complications

    Time frame: Up to 11 months after randomization

    Patients experienced flu-related complications before as defined by relevant diagnosis, hospitalization, or death, between enrollment and July 31, 2025 as recorded in the electronic health record

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Collaborators

  • Abdul Latif Jameel Poverty Action Lab
  • Massachusetts Institute of Technology
  • University of Michigan

Registry information

Official study title

A Prospective Randomized Trial of Personalized Nudges to Increase Influenza Vaccinations

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2024
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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