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Decision Support for Heart Failure Prescribing

New Solutions to Support Evidence-based Prescribing for Heart Failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06293794
Enrollment
764
Registered
2024-03-05
Start date
2025-02-11
Completion date
2027-08-31
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decision Support Systems, Clinical, Heart Failure

Brief summary

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.

Interventions

OTHERPersonalized 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.

OTHERTraditional Clinical Decision Support (CDS)

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

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of CDS alerts resulting in the prescription of a recommended medication6 monthsThe primary outcome is number of CDS alerts that resulted in the prescription of the medication recommended by the CDS alert. Recommended medications include either evidence-based beta blockers, sacubitril/valsartan, mineralocorticoid receptor antagonists or sodium/glucose cotransport 2 inhibitors. Prescriptions will be based on actual prescription orders instead of clinician-stated responses, given the latter may overestimate effectiveness.

Secondary

MeasureTime frameDescription
Number of patients the CDS alerted for6 monthsThis outcome evaluates the reach of the CDS by counting the number of patients that the CDS alerted for.
Number of alerts that were not outright dismissed6 monthsThis outcome will help investigators understand if the CDS id being used or dismissed.
Number of prescription orders for guideline directed management and therapies (GDMT) for heart failure6 monthsThis outcome measures the number of prescriptions for each of the four categories of GDMT: evidence-based beta blockers, sacubitril/valsartan, mineralocorticoid receptor antagonists or sodium/glucose cotransport 2 inhibitors.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKaty E Trinkley, PharmD, PhD

University of Colorado, Denver

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026