Decision Support for Heart Failure Prescribing

Heart Failure Clinical Trial

Official title:

New Solutions to Support Evidence-based Prescribing for Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06293794
• Other study ID #: 22-0991
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Katy Trinkley, PharmD, PhD
• Phone: (303) 724-3103
• Email: katy.trinkley[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1075
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Decision Support Systems, Clinical
• Heart Failure

Intervention

Other:
• 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.
• Traditional Clinical Decision Support (CDS)
The traditional CDS is the usual care intervention, which is patient-specific but are not clinician-specific.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of CDS alerts resulting in the prescription of a recommended medication	The 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.	6 months
Secondary	Number of patients the CDS alerted for	This outcome evaluates the reach of the CDS by counting the number of patients that the CDS alerted for.	6 months
Secondary	Number of alerts that were not outright dismissed	This outcome will help investigators understand if the CDS id being used or dismissed.	6 months
Secondary	Number of prescription orders for guideline directed management and therapies (GDMT) for heart failure	This 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.	6 months