- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05493787
Nudging Flu Vaccination by Making it Easy for Patients to Schedule a Flu Shot
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17822
- Geisinger Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Passive control
No message
|
|
Active Comparator: Active control message
A message that simply states that patients can get a flu shot at Geisinger
|
Patient portal, SMS, email, and/or another modality
|
Experimental: Ease message
A message emphasizing the ease of scheduling a flu shot at Geisinger
|
Patient portal, SMS, email, and/or another modality
|
Experimental: Waiting for you message
A message that states the patient's flu shot is "waiting" for them at Geisinger
|
Patient portal, SMS, email, and/or another modality
|
Experimental: Protect yourself - rare message
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
|
Patient portal, SMS, email, and/or another modality
|
Experimental: Protect yourself - frequent message
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
|
Patient portal, SMS, email, and/or another modality
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flu shot self-scheduling
Time Frame: Within 4 weeks of message send date
|
Patient self-schedules a flu vaccine appointment through the patient portal (yes/no) 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. |
Within 4 weeks of message send date
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flu vaccination
Time Frame: Within 4 weeks of message send date
|
Patient receives a flu vaccine (yes/no)
|
Within 4 weeks of message send date
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
High confidence flu diagnosis
Time Frame: Up to 7 months
|
Patient received a flu diagnosis via a positive PCR/antigen/molecular test (yes/no) during the 2022-23 flu season (from the patient's message send date through April 30, 2023).
|
Up to 7 months
|
"Likely flu" diagnosis
Time Frame: Up to 7 months
|
Received a "high confidence flu" diagnosis (with positive polymerase chain reaction [PCR]/antigen/molecular test) and/or "likely flu" diagnosis (as assessed via International Classification of Disease [ICD] codes or Tamiflu administration or positive PCR/antigen/molecular test) (yes/no) during the 2022-23 flu season (from the patient's message send date through April 30, 2023). Note that "likely flu" is a superset of the "high confidence flu" diagnoses. |
Up to 7 months
|
Flu complications
Time Frame: Up to 10 months
|
Diagnosed with flu-related complications (yes/no) from the patient's message send date through July 31, 2023.
|
Up to 10 months
|
ER visits
Time Frame: Up to 10 months
|
Number of ER visits from the patient's message send date through July 31, 2023.
|
Up to 10 months
|
Hospitalizations
Time Frame: Up to 10 months
|
Number of hospitalizations from the patient's message send date through July 31, 2023.
|
Up to 10 months
|
COVID-19 vaccination rates
Time Frame: Up to 7 months
|
Received at least one COVID-19 vaccination (yes/no) during the 2022-23 flu season (from the patient's message send date through April 30, 2023).
|
Up to 7 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022-0500
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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