Evaluating the Reach of Clinical Decision Support for Patients With Heart Failure

To work best, clinical decision support tools (CDS) must be timed to provide support when healthcare decisions are made, which includes virtual visits (phone or video). Unfortunately, most CDS tools are either missing from virtual visits or not designed for the unique context of virtual visits (e.g., availability of physical assessments and labs, different workflows), which could generate new inequities for patients more likely to use virtual visits. The objective of this study is to test the reach, feasibility and acceptability of a new CDS tool for heart failure with reduced ejection fraction (HFrEF) during virtual visits. This new CDS tool was developed through an iterative design process, and will be compared to an existing HFrEF CDS tool in a randomized pilot study at outpatient cardiology clinics throughout the UCHealth system.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Decision Support Systems, Clinical
• Intervention / Treatment: Other: Iteratively designed (new) clinical decision support tool for virtual visits; Other: Traditional clinical decision support tool

• Study Type: Interventional
• Enrollment (Actual): 20
• 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: No

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 clinics. Because we are observing their prescribing behaviors in a virtual care setting (phone or video), we are also evaluating patient characteristics which could influence their prescribing decisions.

Exclusion Criteria:

• Clinicians who do not practice in a UCHealth cardiology clinic.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iteratively designed (new) clinical decision support tool for virtual visits; The new, iteratively designed clinical decision support tool includes the traditional CDS along with links to supportive tip-sheets, which include one for providers on how to add an order for patients to upload vitals in their electronic health record, and one that walks patients through how to upload vitals on their own.	Other: Iteratively designed (new) clinical decision support tool for virtual visits; The new, iteratively designed clinical decision support tool includes the traditional CDS along with links to supportive tipsheets, which include one for providers on how to add an order for patients to upload vitals in their electronic health record, and one that walks patients through how to upload vitals on their own.
Experimental: Traditional clinical decision support tool; The traditional CDS tool is the usual care intervention, and does not include links to tip-sheets to support virtual patient care.	Other: Traditional clinical decision support tool; The traditional CDS tool is the usual care intervention, and does not include links to tipsheets to support virtual patient care.

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 times a prescriber ordered at-home vitals	This outcome will count the number of times a prescriber orders patients to take their vitals at home after being exposed to the CDS tool.	6 months
Number of patients who upload their vitals in the patient portal	This outcome will count the number of patients who upload their vitals into the electronic medical record.	9 months
Number of prescription orders for guideline directed medical therapy (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
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Katy Trinkley, PharmD, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Actual): August 6, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 26, 2025

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: 22-1154; 23SCISA1144584 (Other Identifier: American Heart Association)

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