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临床试验/NCT06238726
NCT06238726已完成不适用

Nudging Patients to Increase Shingles Vaccination

Geisinger Clinic1 个研究点 分布在 1 个国家目标入组 50,786 人开始时间: 2024年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50,786
试验地点
1
主要终点
First Shingrix vaccination

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

Although patients will not be explicitly informed of which arm they were randomized to, they will be aware of the messages they receive.

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Reminder (Behavioral)

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.

干预措施: Reminder (Behavioral)

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.

干预措施: Reminder (Behavioral)

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.

干预措施: Reminder (Behavioral)

结局指标

主要结局

First Shingrix vaccination

时间窗: 3 days after enrollment

Received a first Shingrix vaccination on the appointment date (y/n)

Shingrix Vaccination on Appointment Day

时间窗: 3 days after enrollment

Received a first Shingrix vaccination on the appointment date (y/n)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher F Chabris, PhD

Professor & Director of Decision Sciences

Geisinger Clinic

研究点 (1)

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