Investigating the Impact of Nudging Cardiologists to Prescribe Guideline-directed Medical Therapy in Heart Failure Patients

NCT ID: NCT06844006

Last Updated: 2025-03-07

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

RECRUITING

Clinical Phase

NA

Total Enrollment

1320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-13

Study Completion Date

2028-08-31

Brief Summary

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This study investigates the impact of a nudge-based intervention on improving guideline directed medical therapy (GDMT) prescription among cardiologists. Using a stepped wedge randomized controlled trial design, we assess whether digital decision support-leveraging home monitoring and clinical data-enhances adherence to guideline-recommended medication titration. The primary outcomes include HF related hospitalization rates and all cause mortality.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Stepped Wedge Randomized Controlled Trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

All cardiologists will be nudged during the trial. with the use of a stepped wedge design there will be a structured embedding in the current standard of care.

Group Type OTHER

Nudging

Intervention Type COMBINATION_PRODUCT

Clinicians will be nudged with a prompt, based on remote monitoring data, current medication data, contraindications, in the electronic patient dossier whether further optimization to guideline directed medical therapy (GDMT) is possible.

Interventions

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Nudging

Clinicians will be nudged with a prompt, based on remote monitoring data, current medication data, contraindications, in the electronic patient dossier whether further optimization to guideline directed medical therapy (GDMT) is possible.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* All heart failure diagnoses
* \>18 years

Exclusion Criteria

* Not understanding the Dutch Language.
* Allergies that make uptitration impossible.
* Admission to hospice or palliative care.
* Severe psychological disorders.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Onze Lieve Vrouwe Gasthuis

OTHER

Sponsor Role collaborator

St. Antonius Hospital

OTHER

Sponsor Role collaborator

Martini Hospital Groningen

OTHER

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role collaborator

Canisius Wilhelmina Ziekenhuis (CWZ)

UNKNOWN

Sponsor Role collaborator

Maasstad Hospital, Rotterdam

UNKNOWN

Sponsor Role collaborator

Medisch Spectrum Twente

OTHER

Sponsor Role lead

Responsible Party

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Mark Schuuring

Assistent Professor M.J. Schuuring (M.D., Ph. D., FESC, FEACVI, FHFA)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Facility Contacts

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M.D., Ph.D., FESC, FEACVI, FHFA

Role: primary

References

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Man JP, Koole MAC, Meregalli PG, Handoko ML, Stienen S, de Lange FJ, Winter MM, Schijven MP, Kok WEM, Kuipers DI, van der Harst P, Asselbergs FW, Zwinderman AH, Dijkgraaf MGW, Chamuleau SAJ, Schuuring MJ. Digital consults in heart failure care: a randomized controlled trial. Nat Med. 2024 Oct;30(10):2907-2913. doi: 10.1038/s41591-024-03238-6. Epub 2024 Aug 31.

Reference Type BACKGROUND
PMID: 39217271 (View on PubMed)

Related Links

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Other Identifiers

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ADMINISTER II

Identifier Type: -

Identifier Source: org_study_id

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