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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06847906
Enrollment
20
Registered
2025-02-26
Start date
2025-02-25
Completion date
2026-06-30
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

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.

Interventions

OTHERIteratively 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.

OTHERTraditional 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.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER
American Heart Association
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Intervention model description

Compare two different types of a virtual CDS tool in a randomized pilot study at one health system.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

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 times a prescriber ordered at-home vitals6 monthsThis outcome will count the number of times a prescriber orders patients to take their vitals at home after being exposed to the CDS tool.
Number of patients who upload their vitals in the patient portal9 monthsThis outcome will count the number of patients who upload their vitals into the electronic medical record.
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 medical therapy (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 Trinkley, PharmD, PhD

University of Colorado, Denver

Outcome results

None listed

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