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

NCT06844006 | Recruiting

• 1 other identifier: ADMINISTER II
• Study Type: interventional
• Target: 1,320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Digitial Care; Home monitoring; Heart Failure; Nudging

Outcome Measures

Primary Outcomes (2)

• HF related hospitalization

  The frequency of HF related hospitalization and duration of the 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.

Study Arms (1)

Intervention

OTHER

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.

Combination Product: Nudging

Interventions

Nudging 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All heart failure diagnoses
• \>18 years

You may not qualify if:

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

Sponsors & Collaborators

• Medisch Spectrum Twente: lead
• Onze Lieve Vrouwe Gasthuis: collaborator
• St. Antonius Hospital: collaborator
• Martini Hospital Groningen: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Canisius Wilhelmina Ziekenhuis (CWZ): collaborator
• Maasstad Hospital, Rotterdam: collaborator

Study Sites (1)

Medisch Spectrum Twente

Enschede, Overijssel, 7512KZ, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 39217271 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistent Professor M.J. Schuuring (M.D., Ph. D., FESC, FEACVI, FHFA)

Model Details: Stepped Wedge Randomized Controlled Trial.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: June 13, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

NL (1)