A Prospective Randomized Trial of Personalized Nudges to Increase Influenza Vaccinations

Last registered on September 12, 2024

Pre-Trial

Trial Information

General Information

Title
A Prospective Randomized Trial of Personalized Nudges to Increase Influenza Vaccinations
RCT ID
AEARCTR-0014236
Initial registration date
August 30, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
September 12, 2024, 5:22 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
Geisinger

Other Primary Investigator(s)

PI Affiliation
Geisinger
PI Affiliation
Geisinger
PI Affiliation
Geisinger
PI Affiliation
Geisinger
PI Affiliation
Geisinger
PI Affiliation
Massachusetts Institute of Technology

Additional Trial Information

Status
In development
Start date
2024-09-03
End date
2025-12-31
Secondary IDs
NCT06566534
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
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 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 (Milkman et al. 2021, Patel et al., 2023) 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 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 COVID-19 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.

Registration Citation

Citation
Brietzke, Sasha et al. 2024. "A Prospective Randomized Trial of Personalized Nudges to Increase Influenza Vaccinations." AEA RCT Registry. September 12. https://doi.org/10.1257/rct.14236-1.0
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
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.
Intervention (Hidden)
Intervention Start Date
2024-09-03
Intervention End Date
2024-12-31

Primary Outcomes

Primary Outcomes (end points)
Number of Patients With Flu Shot Receipt Between Enrollment Date and Target Appointment Date
Primary Outcomes (explanation)
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 have been randomized to a treatment who do not show up for their target appointment and do not schedule a new appointment during the study period will be included in the analysis. Their outcome window will be three days prior to the original canceled

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

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The present study aims to prospectively test the efficacy of a patient-facing, message-based nudge 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.

Passive Control: Patients randomized to this arm will receive no special communications, beyond what Geisinger sends out as standard practice.

Active Control: Patients will receive a simple message encouraging them to get a flu shot at their appointment.

Best Nudge: Patients will receive the nudge found to be numerically most effective in the megastudy, including language that a flu vaccine is "reserved" for them at their upcoming appointment.

Personalized Nudge: Patients will receive the nudge predicted to be most effective for them on the basis of the machine learning-derived treatment assignment trees.

Sample size is estimated to be about 90,000 patients.
Experimental Design Details
Randomization Method
Randomization done by a computer.
Randomization Unit
Individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
90,000 patients
Sample size: planned number of observations
90,000 patients
Sample size (or number of clusters) by treatment arms
15,000 patients in the passive control arm
25,000 patients in all experimental arms
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Based on current data, we estimate that at least 90,000 patients will be enrolled in the study. The number of patients per arm will vary according to the expected effect sizes for planned analyses. Our target is to enroll 15,000 patients in the passive control arm, and 25,000 patients in all other experimental arms. We expect a baseline primary outcome vaccination rate of 25% in the passive control arm, and for experimental interventions to increase vaccinations by 2 percentage points to 27% on average. By allocating 15,000 patients to passive control 25,000 in all other arms, we have 80% statistical power to detect, at minimum, a 1.3% increase in vaccination from 25% to 26.3%, with a two-tailed p < .05. Although we expect personalization to greatly improve nudge effectiveness, differences between active experimental arms tend to be smaller than differences between active and passive arms. Therefore, we have allocated our sample to detect, at minimum, a slightly smaller effect of a 1.1 percentage point increase from 27% to 28.1%, with 80% power and two-tailed p<.05. If more updated sample size estimates show fewer than 90,000 patients, then we may change the allocation accordingly with logic similar to that outlined above.
IRB

Institutional Review Boards (IRBs)

IRB Name
Geisinger Institutional Review Board
IRB Approval Date
2024-07-09
IRB Approval Number
2024-0561
Analysis Plan

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Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials