PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC

NCT ID: NCT06344910

Last Updated: 2024-08-09

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

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-21

Study Completion Date

2025-12-31

Brief Summary

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This is a prospective cohort study, where the investigators aim to investigate the effect of implementation of an electronic nudge alerting clinicians to the prescription of the 4 key pharmacological classes for the treatment of patients with heart failure and reduced ejection fraction (HFrEF) at the outpatient clinic in the Netherlands.

Detailed Description

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Conditions

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Heart Failure With Reduced Ejection Fraction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with HFrEF

Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies

Intervention Type OTHER

An algorithm will check if the patients if the patient has an age \>18 year and is treated at the cardiology department for HFrEF. The use of GDMT is determined using prescriptions data electronic health records (EHR). If the patient does not receive treatment for all 4 drug classes (ACE/ARB/ARNi, beta-blocker, MRA, SGLT2-inhibitor), an electronic alert will be displayed suggesting the clinician to prescribe additional medication when clinically indicated, including relevant recent laboratory results (renal function and electrolytes) and other relevant measures (LVEF, blood pressure and heart rate). The alert is linked to an order set to aid in the prescription of GDMT according to current guidelines.

Results will compared to a retrospective cohort (t=-12 to t=-6) months, and a silent mode cohort (t=-6 to t=0 months, in which a paired and a before and after analysis will be performed to evaluate the effect of the alert.

Interventions

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Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies

An algorithm will check if the patients if the patient has an age \>18 year and is treated at the cardiology department for HFrEF. The use of GDMT is determined using prescriptions data electronic health records (EHR). If the patient does not receive treatment for all 4 drug classes (ACE/ARB/ARNi, beta-blocker, MRA, SGLT2-inhibitor), an electronic alert will be displayed suggesting the clinician to prescribe additional medication when clinically indicated, including relevant recent laboratory results (renal function and electrolytes) and other relevant measures (LVEF, blood pressure and heart rate). The alert is linked to an order set to aid in the prescription of GDMT according to current guidelines.

Results will compared to a retrospective cohort (t=-12 to t=-6) months, and a silent mode cohort (t=-6 to t=0 months, in which a paired and a before and after analysis will be performed to evaluate the effect of the alert.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Treatment for HFrEF at the outpatient clinic cardiology.
* Documented reduced ejection fraction of \<40% based on cardiac ultrasound or cardiac magnetic resonance imaging.

Exclusion Criteria

* Opt-out for the use of routine clinical data for research purposes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Folkert W. Asselbergs

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amsterdam University Medical Centers, Location AMC

Amsterdam, , Netherlands

Site Status RECRUITING

Amsterdam University Medical Centers, Location VU Medical Center

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Folkert Assselbergs, MD PhD

Role: CONTACT

0031205669111

A Uijl

Role: CONTACT

Facility Contacts

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F Asselbergs

Role: primary

F Asselberg

Role: primary

Other Identifiers

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20230416-C1_v2

Identifier Type: -

Identifier Source: org_study_id

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