Clinical trial NCT06293794: Decision Support for Heart Failure Prescribing
Official title: New Solutions to Support Evidence-based Prescribing for Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Decision Support Systems, Clinical
Heart Failure
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 1075
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compare traditional and personalized CDS in a pragmatic randomized controlled trial at one health system.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of CDS alerts resulting in the prescription of a recommended medication
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients the CDS alerted for
timeFrame: 6 months
measure: Number of alerts that were not outright dismissed
timeFrame: 6 months
measure: Number of prescription orders for guideline directed management and therapies (GDMT) for heart failure
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: UCHealth Primary Care and Cardiology Outpatient Clinics
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Katy E Trinkley, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: