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

NCT06847906 | Recruiting

• 2 other identifiers: 22-115423SCISA1144584
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Decision Support Systems, Clinical; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

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

EXPERIMENTAL

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

Traditional clinical decision support tool

EXPERIMENTAL

Other: Traditional clinical decision support tool

Interventions

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

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.

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

Traditional clinical decision support tool OTHER

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

Traditional clinical decision support tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Heart Association (AHA): collaborator

Study Sites (1)

UCHealth Primary Care and Cardiology Outpatient Clinics

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Katy Trinkley, PharmD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katy Trinkley, PharmD, PhD

CONTACT

(303) 724-3103; katy.trinkley@cuanschutz.edu

Meagan Bean, MPH

CONTACT

9155250110; meagan.bean@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: February 25, 2025
• Primary Completion: August 6, 2025
• Study Completion: January 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)