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Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake (NUDGE-FLU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05542004
Recruitment Status : Active, not recruiting
First Posted : September 15, 2022
Last Update Posted : February 28, 2023
Sponsor:
Collaborators:
Statens Serum Institut
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Tor Biering-Sørensen, Herlev and Gentofte Hospital

Study Description
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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. This study will investigate investigate whether digital behavioral nudges delivered via the official, mandatory Danish electronic letter system can increase influenza vaccine uptake among eligible influenza vaccination candidates.

Condition or disease Intervention/treatment Phase
Influenza Behavior and Behavior Mechanisms Behavioral: Behavioral Economic Principles Not Applicable

Detailed Description:
The study is a prospective, randomized, open-label implementation trial. The study population will consist of persons identified as eligible for free-of-charge influenza vaccination in the Danish health system aged 18 years and above. Subjects will be identified through Danish nationwide health registries using codes from the International Classification of Diseases, 10th revision (ICD-10) and the Anatomical Therapeutic Chemical (ATC) classification system. Individuals will be randomized to 1 of 10 arms (1 control arm and 9 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. The study will be performed in collaboration with the Danish Health Data Authority and Statens Serum Institut.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 964870 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake
Actual Study Start Date : September 16, 2022
Actual Primary Completion Date : January 1, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
No letter
Experimental: Standard Letter
This group will receive a standard letter on the benefits of influenza vaccination without behavioral economic enhancement
 Behavioral: Behavioral Economic Principles
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.
Experimental: Priming & Hot State Activation - 1 reminder
The standard letter sent out two times instead of once
 Behavioral: Behavioral Economic Principles
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.
Experimental: Depersonalized Letter
The standard letter without the recipient's name
 Behavioral: Behavioral Economic Principles
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.
Experimental: Gain-Framing/Context
Text added to the standard letter employing the specified behavioral economic principle
 Behavioral: Behavioral Economic Principles
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.
Experimental: Loss-Framing/Context
Text added to the standard letter employing the specified behavioral economic principle
 Behavioral: Behavioral Economic Principles
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.
Experimental: Collective Goal
Text added to the standard letter employing the specified behavioral economic principle
 Behavioral: Behavioral Economic Principles
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.
Experimental: Active Choice/Implementation Intention Prompt
Text added to the standard letter employing the specified behavioral economic principle
 Behavioral: Behavioral Economic Principles
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.
Experimental: Cardiovascular Gain Frame
Text added to the standard letter employing the specified behavioral economic principle
 Behavioral: Behavioral Economic Principles
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.
Experimental: Expert Authority
Text added to the standard letter employing the specified behavioral economic principle
 Behavioral: Behavioral Economic Principles
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants who received an influenza vaccine [ Time Frame: Up to 3 months ]

Secondary Outcome Measures :
  1. Time from intervention delivery to influenza vaccination [ Time Frame: Up to 3 months ]

Other Outcome Measures:
  1. Number of participants with laboratory-confirmed influenza [ Time Frame: Up to 8 months ]
  2. Number of participants with a hospitalization with influenza or pneumonia [ Time Frame: Up to 8 months ]
  3. Number of participants with any hospitalization [ Time Frame: Up to 8 months ]
  4. All-cause mortality [ Time Frame: Up to 8 months ]
  5. Composite of incident heart failure, heart failure hospitalization, or cardiovascular death [ Time Frame: Up to 8 months ]
  6. Composite of myocardial infarction, stroke, or cardiovascular death [ Time Frame: Up to 8 months ]
  7. Composite of myocardial infarction, coronary revascularization, stroke, or cardiovascular death [ Time Frame: Up to 8 months ]
  8. Number of participants with incident heart failure or heart failure hospitalization [ Time Frame: Up to 8 months ]
  9. Cardiovascular death [ Time Frame: Up to 8 months ]
  10. Number of participants with myocardial infarction [ Time Frame: Up to 8 months ]
  11. Number of participants with coronary revascularization [ Time Frame: Up to 8 months ]
  12. Number of participants with stroke [ Time Frame: Up to 8 months ]
  13. Number of contacts to general practitioner (excluding vaccination visit) [ Time Frame: Up to 8 months ]
  14. Number of participants with laboratory-confirmed COVID-19 [ Time Frame: Up to 8 months ]
  15. Number of participants with a hospitalization due to COVID-19 [ Time Frame: Up to 8 months ]
  16. Number of participants who received a COVID-19 vaccine [ Time Frame: Up to 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age >=65 years at January 15, 2023 (eligible for free influenza vaccination in the official Danish vaccination program)
  2. Access to the official, mandatory Danish electronic mailbox system

Exclusion Criteria:

1) Persons living in nursing homes

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05542004


Locations
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Denmark
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, Hovedstaden, Denmark, 2900
Sponsors and Collaborators
Tor Biering-Sørensen
Statens Serum Institut
Sanofi Pasteur, a Sanofi Company
Investigators
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Principal Investigator: Tor Biering-Sørensen, MD, PhD, MPH Research Director
More Information
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Responsible Party: Tor Biering-Sørensen, Professor, MD, PhD, MPH, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT05542004    
Other Study ID Numbers: FLU00180
First Posted: September 15, 2022    Key Record Dates
Last Update Posted: February 28, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tor Biering-Sørensen, Herlev and Gentofte Hospital:
Influenza
Vaccination
Nudging
Behavioral Science
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases