Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake

NCT ID: NCT05542004

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

964870 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-16

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Influenza Behavior and Behavior Mechanisms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

No letter

Group Type NO_INTERVENTION

No interventions assigned to this group

Standard Letter

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

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Priming & Hot State Activation - 1 reminder

The standard letter sent out two times instead of once

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Depersonalized Letter

The standard letter without the recipient's name

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Gain-Framing/Context

Text added to the standard letter employing the specified behavioral economic principle

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Loss-Framing/Context

Text added to the standard letter employing the specified behavioral economic principle

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Collective Goal

Text added to the standard letter employing the specified behavioral economic principle

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Active Choice/Implementation Intention Prompt

Text added to the standard letter employing the specified behavioral economic principle

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Cardiovascular Gain Frame

Text added to the standard letter employing the specified behavioral economic principle

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Expert Authority

Text added to the standard letter employing the specified behavioral economic principle

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Statens Serum Institut

OTHER

Sponsor Role collaborator

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

Tor Biering-Sørensen

OTHER

Sponsor Role lead

Responsible Party

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Tor Biering-Sørensen

Professor, MD, PhD, MPH

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tor Biering-Sørensen, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Research Director

Locations

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

Hellerup, Capital Region, Denmark

Site Status

Countries

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Denmark

References

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Bhatt AS, Johansen ND, Vaduganathan M, Modin D, Pareek M, Chatur S, Claggett BL, Janstrup KH, Larsen CS, Larsen L, Wiese L, Dalager-Pedersen M, Dueger EL, Samson S, Loiacono MM, Harris RC, Kober L, Solomon SD, Martel CJ, Sivapalan P, Jensen JUS, Biering-Sorensen T. Electronic Nudges and Influenza Vaccination Among Patients With a History of Myocardial Infarction: Insights From 3 Nationwide Randomized Clinical Trials. JAMA Cardiol. 2025 Jan 1;10(1):78-86. doi: 10.1001/jamacardio.2024.4648.

Reference Type DERIVED
PMID: 39550717 (View on PubMed)

Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Modin D, Claggett BL, Dueger EL, Samson S, Loiacono MM, Harris RC, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Martel CJ, Krause TG, Biering-Sorensen T. Clinical Outcomes With Electronic Nudges to Increase Influenza Vaccination : A Prespecified Analysis of a Nationwide, Pragmatic, Registry-Based, Randomized Implementation Trial. Ann Intern Med. 2024 Apr;177(4):476-483. doi: 10.7326/M23-2638. Epub 2024 Mar 19.

Reference Type DERIVED
PMID: 38498876 (View on PubMed)

Lassen MCH, Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Modin D, Claggett BL, Dueger EL, Samson SI, Loiacono MM, Fralick M, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Martel CJ, Krause TG, Biering-Sorensen T. Electronically Delivered Nudges to Increase Influenza Vaccination Uptake in Older Adults With Diabetes: A Secondary Analysis of the NUDGE-FLU Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2347630. doi: 10.1001/jamanetworkopen.2023.47630.

Reference Type DERIVED
PMID: 38117499 (View on PubMed)

Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Modin D, Claggett BL, Dueger EL, Samson S, Loiacono MM, Harris RC, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Martel CJ, Valentiner-Branth P, Krause TG, Biering-Sorensen T. Electronic nudges to increase influenza vaccination uptake among patients with heart failure: A pre-specified analysis of the NUDGE-FLU trial. Eur J Heart Fail. 2023 Aug;25(8):1450-1458. doi: 10.1002/ejhf.2913. Epub 2023 Jun 4.

Reference Type DERIVED
PMID: 37211967 (View on PubMed)

Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Modin D, Claggett BL, Dueger EL, Samson SI, Loiacono MM, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Martel CJ, Valentiner-Branth P, Krause TG, Biering-Sorensen T. Electronic nudges to increase influenza vaccination uptake in Denmark: a nationwide, pragmatic, registry-based, randomised implementation trial. Lancet. 2023 Apr 1;401(10382):1103-1114. doi: 10.1016/S0140-6736(23)00349-5. Epub 2023 Mar 5.

Reference Type DERIVED
PMID: 36889332 (View on PubMed)

Modin D, Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Claggett BL, Dueger EL, Samson SI, Loiacono MM, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Jean-Marie Martel C, Valentiner-Branth P, Krause TG, Biering-Sorensen T. Effect of Electronic Nudges on Influenza Vaccination Rate in Older Adults With Cardiovascular Disease: Prespecified Analysis of the NUDGE-FLU Trial. Circulation. 2023 May 2;147(18):1345-1354. doi: 10.1161/CIRCULATIONAHA.123.064270. Epub 2023 Mar 5.

Reference Type DERIVED
PMID: 36871213 (View on PubMed)

Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Modin D, Claggett BL, Dueger EL, Samson S, Loiacono MM, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Valentiner-Branth P, Krause TG, Biering-Sorensen T. Nationwide Utilization of Danish Government Electronic letter system for increasing inFLUenza vaccine uptake (NUDGE-FLU): Study protocol for a nationwide randomized implementation trial. Am Heart J. 2023 Jun;260:58-71. doi: 10.1016/j.ahj.2023.02.009. Epub 2023 Feb 17.

Reference Type DERIVED
PMID: 36801265 (View on PubMed)

Other Identifiers

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FLU00180

Identifier Type: -

Identifier Source: org_study_id

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