Decision Support for Heart Failure Prescribing

New Solutions to Support Evidence-based Prescribing for Heart Failure

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Decision Support Systems, Clinical
• Intervention / Treatment: Other: Traditional Clinical Decision Support (CDS); Other: Personalized Clinical Decision Support (CDS)

• Study Type: Interventional
• Enrollment (Actual): 764
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UCHealth Primary Care and Cardiology Outpatient Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional Clinical Decision Support (CDS); Clinicians will receive traditional CDS and perform usual care, which is patient-specific but not clinician-specific.	Other: Traditional Clinical Decision Support (CDS); The traditional CDS is the usual care intervention, which is patient-specific but are not clinician-specific.
Experimental: Personalized Clinical Decision Support (CDS); Clinicians will receive a personalized CDS intervention that evaluates clinician past prescribing patterns to determine whether prescribing misconceptions might exist, and then conditionally present information to address those misconceptions through a nudge in the EHR.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of alerts that were not outright dismissed	This outcome will help investigators understand if the CDS id being used or dismissed.	6 months
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Katy E Trinkley, PharmD, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Actual): August 1, 2025
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 22-0991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in related areas of interest. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (e.g., data use/sharing agreements) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months.
• IPD Sharing Access Criteria: Data obtained through this study may be provided to qualified researchers with academic interest in related areas of interest. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (e.g., data use/sharing agreements) are prerequisites to the sharing of data with the requesting party. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No