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

NCT06844006 · Medisch Spectrum Twente

Recruiting

In plain English

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Official title

Assessment of Digital Care on Clinical Impact and Efficiency Using a Stepped Wedge Cluster RCT in Heart Failure Patients: the ADMINISTER II Trial

About this study

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.

Eligibility criteria

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.

Study design

Enrollment target: 1320 participants

Allocation: na

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2024-06-13

Estimated completion: 2028-08-31

Last updated: 2025-03-07

Interventions

Combination Product: Nudging

Primary outcomes

• HF related hospitalization (From enrollment to the end of the design (15 months).)
• All cause death (All cause death rate during the 15 month duration of the study.)

Sponsor

Medisch Spectrum Twente · other

With: Onze Lieve Vrouwe Gasthuis, St. Antonius Hospital, Martini Hospital Groningen, Catharina Ziekenhuis Eindhoven, Canisius-Wilhelmina Hospital, Maasstad Hospital, Rotterdam

All locations (1)

Medisch Spectrum TwenteRecruiting

Enschede, Overijssel, Netherlands

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