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Clinical Trials/NCT06847906
NCT06847906Active, not recruitingNot Applicable

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

University of Colorado, Denver1 site in 1 country20 target enrollmentStarted: February 25, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
20
Locations
1
Primary Endpoint
Number of CDS alerts resulting in the prescription of a recommended medication

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

Iteratively designed (new) clinical decision support tool for virtual visits

Experimental

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.

Intervention: Iteratively designed (new) clinical decision support tool for virtual visits (Other)

Traditional clinical decision support tool

Experimental

The traditional CDS tool is the usual care intervention, and does not include links to tip-sheets to support virtual patient care.

Intervention: Traditional clinical decision support tool (Other)

Outcomes

Primary Outcomes

Number of CDS alerts resulting in the prescription of a recommended medication

Time Frame: 6 months

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.

Secondary Outcomes

  • Number of patients the CDS alerted for(6 months)
  • Number of times a prescriber ordered at-home vitals(6 months)
  • Number of patients who upload their vitals in the patient portal(9 months)
  • Number of alerts that were not outright dismissed(6 months)
  • Number of prescription orders for guideline directed medical therapy (GDMT) for heart failure(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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