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

NCT ID: NCT06847906

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-25

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Decision Support Systems, Clinical Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Traditional clinical decision support tool

Group Type EXPERIMENTAL

Traditional clinical decision support tool

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association (AHA)

UNKNOWN

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katy Trinkley, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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UCHealth Primary Care and Cardiology Outpatient Clinics

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katy Trinkley, PharmD, PhD

Role: CONTACT

(303) 724-3103

Meagan Bean, MPH

Role: CONTACT

9155250110

Facility Contacts

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Katy Trinkley, PharmD, PhD

Role: primary

303-724-3103

Other Identifiers

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23SCISA1144584

Identifier Type: OTHER

Identifier Source: secondary_id

22-1154

Identifier Type: -

Identifier Source: org_study_id

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