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Nationwide Utilization of Danish Government Electronic Letter System for Confirming the Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Older Adults (NUDGE-FLU-2)

Primary Purpose

Influenza, Behavior and Behavior Mechanisms

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Behavioral Economic Principles
Sponsored by
Tor Biering-Sørensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Influenza focused on measuring Influenza, Vaccination, Nudging, Behavioral Science

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age >=65 years at January 15, 2024 (eligible for free-of-charge influenza vaccination in the Danish public health system) Access to the official, mandatory Danish electronic mailbox system Exclusion Criteria: Persons living in nursing homes (approximated as any person living at an address with >=6 inhabitants aged 80 years and above) Known to have already scheduled influenza vaccination appointment

Sites / Locations

  • Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Usual Care

Standard Letter

Repeated Letter

Cardiovascular Gain-Framing Letter

Respiratory Gain-Framing Letter

Implementation Intention Prompt Letter

Loss-Framing Letter

Arm Description

No letter

This group will receive a standard letter on the benefits of influenza vaccination without behavioral economic enhancement

The standard letter sent out two times instead of once

Text added to the standard letter highlighting potential cardiovascular benefits of influenza vaccination

Text added to the standard letter highlighting potential respiratory disease-related benefits of influenza vaccination

Implementation intention prompt added to the standard letter

Text added to the standard letter highlighting potential risks of not receiving influenza vaccination

Outcomes

Primary Outcome Measures

Number of participants who received an influenza vaccine

Secondary Outcome Measures

Time from intervention delivery to influenza vaccination

Full Information

First Posted
August 31, 2023
Last Updated
October 19, 2023
Sponsor
Tor Biering-Sørensen
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1. Study Identification

Unique Protocol Identification Number
NCT06030726
Brief Title
Nationwide Utilization of Danish Government Electronic Letter System for Confirming the Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Older Adults
Acronym
NUDGE-FLU-2
Official Title
Nationwide Utilization of Danish Government Electronic Letter System for Confirming the Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tor Biering-Sørensen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. However, the real-world effectiveness of influenza vaccination is limited by its uptake. Conducted during the 2022/2023 influenza season, the first NUDGE-FLU trial demonstrated the effectiveness of two electronic behavioral nudging letter strategies in increasing influenza vaccination rates among older adults in Denmark - a letter highlighting potential cardiovascular benefits of vaccination and a standard informational letter sent at baseline and repeated at day 14. This present study will once again investigate whether digital behavioral nudges delivered via the official, mandatory Danish electronic letter system can increase influenza vaccine uptake among older adults including whether the effectiveness of previously successful strategies can be confirmed during a subsequent influenza season.
Detailed Description
The study is a prospective, randomized, open-label implementation trial. The study population will consist of persons aged >=65 years at January 15, 2024 - this age group is eligible for free-of-charge influenza vaccination in the official Danish vaccination program. Subjects will be identified through Danish nationwide health registries including the Danish Civil Registration System. Individuals will be randomized to 1 of 7 arms (1 usual care arm and 6 intervention arms) with each testing different nudging strategies employing various behavioural economic principles. The interventions will be delivered through the official, mandatory Danish electronic letter system. All subject data will be retrieved from the Danish nationwide registries with the exception of information on intervention allocation. Endpoints will be retrieved at prespecified dates using prespecified search algorithms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Behavior and Behavior Mechanisms
Keywords
Influenza, Vaccination, Nudging, Behavioral Science

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
881373 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
No letter
Arm Title
Standard Letter
Arm Type
Experimental
Arm Description
This group will receive a standard letter on the benefits of influenza vaccination without behavioral economic enhancement
Arm Title
Repeated Letter
Arm Type
Experimental
Arm Description
The standard letter sent out two times instead of once
Arm Title
Cardiovascular Gain-Framing Letter
Arm Type
Experimental
Arm Description
Text added to the standard letter highlighting potential cardiovascular benefits of influenza vaccination
Arm Title
Respiratory Gain-Framing Letter
Arm Type
Experimental
Arm Description
Text added to the standard letter highlighting potential respiratory disease-related benefits of influenza vaccination
Arm Title
Implementation Intention Prompt Letter
Arm Type
Experimental
Arm Description
Implementation intention prompt added to the standard letter
Arm Title
Loss-Framing Letter
Arm Type
Experimental
Arm Description
Text added to the standard letter highlighting potential risks of not receiving influenza vaccination
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Economic Principles
Intervention Description
The control arm will receive no letter to reflect the background vaccination uptake. Intervention arms will test the effects of different letters developed using behavioral economic principles.
Primary Outcome Measure Information:
Title
Number of participants who received an influenza vaccine
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Time from intervention delivery to influenza vaccination
Time Frame
Up to 3 months
Other Pre-specified Outcome Measures:
Title
Number of participants with laboratory-confirmed influenza
Time Frame
Up to 8 months
Title
Number of participants with a hospitalization for influenza or pneumonia
Time Frame
Up to 8 months
Title
Number of participants with a hospitalization for any respiratory disease
Time Frame
Up to 8 months
Title
Number of participants with a hospitalization for any cardio-respiratory disease
Time Frame
Up to 8 months
Title
Number of participants with a hospitalization for any cardiovascular disease
Time Frame
Up to 8 months
Title
Number of participants with any hospitalization
Time Frame
Up to 8 months
Title
Total number of hospitalizations (first and recurrent)
Time Frame
Up to 8 months
Title
All-cause mortality
Time Frame
Up to 8 months
Title
Composite of incident heart failure, heart failure hospitalization, or cardiovascular death
Time Frame
Up to 8 months
Title
Composite of myocardial infarction, stroke, or cardiovascular death
Time Frame
Up to 8 months
Title
Composite of myocardial infarction, coronary revascularization, stroke, or cardiovascular death
Time Frame
Up to 8 months
Title
Number of participants with incident heart failure or heart failure hospitalization
Time Frame
Up to 8 months
Title
Total number of heart failure events (incident heart failure and first and recurrent heart failure hospitalizations)
Time Frame
Up to 8 months
Title
Cardiovascular death
Time Frame
Up to 8 months
Title
Number of participants with myocardial infarction
Time Frame
Up to 8 months
Title
Number of participants with coronary revascularization
Time Frame
Up to 8 months
Title
Number of participants with stroke
Time Frame
Up to 8 months
Title
Number of participants with incident atrial fibrillation or atrial fibrillation hospitalization
Time Frame
Up to 8 months
Title
Number of contacts to general practitioner (excluding vaccination visit)
Time Frame
Up to 8 months
Title
Number of participants with laboratory-confirmed COVID-19
Time Frame
Up to 8 months
Title
Number of participants with a hospitalization for COVID-19
Time Frame
Up to 8 months
Title
Number of participants who received a COVID-19 vaccine
Time Frame
Up to 3 months
Title
Number of participants who filled a prescription for any guideline-directed medical therapy for heart failure
Time Frame
Up to 8 months
Title
Total number of filled prescriptions for guideline-directed medical therapy for heart failure
Time Frame
Up to 8 months
Title
Number of participants who filled a prescription for a sodium-glucose cotransporter 2 inhibitor or glucagon-like peptide 1 receptor agonist
Time Frame
Up to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age >=65 years at January 15, 2024 (eligible for free-of-charge influenza vaccination in the Danish public health system) Access to the official, mandatory Danish electronic mailbox system Exclusion Criteria: Persons living in nursing homes (approximated as any person living at an address with >=6 inhabitants aged 80 years and above) Known to have already scheduled influenza vaccination appointment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tor Biering-Sørensen, MD, MSc, MPH, PhD
Organizational Affiliation
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
City
Hellerup
State/Province
Hovedstaden
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.

Learn more about this trial

Nationwide Utilization of Danish Government Electronic Letter System for Confirming the Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Older Adults

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