Decision Support for Heart Failure Prescribing

NCT ID: NCT06293794

Last Updated: 2025-08-22

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

764 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-11

Study Completion Date

2025-09-30

Brief Summary

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Clinical decision support (CDS) tools can 'nudge' clinicians to make the best decisions easy. Although required by "meaningful use" regulations, more than 40% of CDS lead to no change and the remaining lead to improvements that are modest at best. This is because CDS tools often ignore contextual factors and present irrelevant information. Although many tools have undergone patient-specific optimization, 'traditional CDS' are rarely clinician-specific. For example, a traditional CDS tool for beta blockers and heart failure with reduced ejection fraction (HFrEF) addresses common prescribing misconceptions by stating asthma is not a contraindication and providing a safe threshold for blood pressure. For clinicians without these misconceptions, these statements are irrelevant and distract from key information. A 'personalized CDS' would evaluate clinician past prescribing patterns to determine whether prescribing misconceptions might exist and then conditionally present information to address those misconceptions. The objective of this research is to create personalized clinician-specific CDS that overcome shortcomings of traditional CDS. The central hypothesis is a personalized CDS that minimizes irrelevant information will lead to a higher rate of prescribing guideline-directed management and therapy (GDMT) for HFrEF compared to a traditional CDS.

Detailed Description

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Conditions

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Decision Support Systems, Clinical Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Compare traditional and personalized CDS in a pragmatic randomized controlled trial at one health system.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Traditional Clinical Decision Support (CDS)

Group Type EXPERIMENTAL

Traditional Clinical Decision Support (CDS)

Intervention Type OTHER

The traditional CDS is the usual care intervention, which is patient-specific but are not clinician-specific.

Personalized Clinical Decision Support (CDS)

Group Type EXPERIMENTAL

Personalized Clinical Decision Support (CDS)

Intervention Type OTHER

The personalized CDS intervention evaluates clinician past prescribing patterns to determine whether prescribing misconceptions might exist and then conditionally present information to address those misconceptions. This is done through a nudge in the electronic health record that addresses common prescribing misconceptions for heart failure.

Interventions

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Personalized Clinical Decision Support (CDS)

The personalized CDS intervention evaluates clinician past prescribing patterns to determine whether prescribing misconceptions might exist and then conditionally present information to address those misconceptions. This is done through a nudge in the electronic health record that addresses common prescribing misconceptions for heart failure.

Intervention Type OTHER

Traditional Clinical Decision Support (CDS)

The traditional CDS is the usual care intervention, which is patient-specific but are not clinician-specific.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The study subjects are potential users of the CDS, specifically clinicians with prescribing privileges who practice at one of the health system's (UCHealth) outpatient cardiology or primary care clinics. Because we are observing their prescribing behaviors, we are also evaluating patient characteristics which could influence their prescribing decisions.

Exclusion Criteria

* Clinicians who do not practice in cardiology or primary care clinics or do not practice within UCHealth system.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katy E Trinkley, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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UCHealth Primary Care and Cardiology Outpatient Clinics

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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22-0991

Identifier Type: -

Identifier Source: org_study_id

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