PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC (PROMPT-HF-AUMC)

August 7, 2024 updated by: Prof. Dr. Folkert W. Asselbergs, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with heart failure and reduced ejection fraction

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with HFrEF
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of guideline-directed medical therapy (GDMT)
Time Frame: 30 days (primary), 6 months (secondary)
Using all therapies according to ESC guidelines
30 days (primary), 6 months (secondary)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 1 year
All-cause mortality
1 year
Hospitalisation for Heart Failure
Time Frame: 6 months, 1 year
Hospitalisation for Heart Failure
6 months, 1 year
other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
Time Frame: 6 months, 1 year
other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
6 months, 1 year
renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)
Time Frame: 30 days, 6 months, 1 year
renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)
30 days, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Yale University
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230416-C1_v2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data underlying the results for publication can be made available upon request

IPD Sharing Time Frame

available upon request

IPD Sharing Access Criteria

available upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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