An Implementation Model for Clinical Decision Support for Heart Failure Prescribing

NCT ID: NCT04028557

Last Updated: 2022-05-06

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-24

Study Completion Date

2019-09-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this proposal is to compare clinical outcomes, implementation metrics (i.e., patient reach and clinician adoption), and clinician preferences of two designs (customized vs. commercial) of a clinical decision support (CDS). Beta blocker prescribing for patients with heart failure will be used as a test case. The best practices in CDS design, including the user-centered design will be incorporated into the customized CDS and compared to a commercially-available CDS in the electronic health record using a cluster randomized trial.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Decision Support Systems, Clinical Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Customized CDS

The customized CDS will be designed and implemented with comprehensive application of known best practice principles in CDS design. The recommendation will be to initiate an evidence-based beta blocker for heart failure.

Group Type EXPERIMENTAL

Decision Support Systems, Clinical

Intervention Type OTHER

Active computerized clinical decision support alert within the electronic health record that recommends initiation of an evidence-based beta blocker for heart failure and reduced ejection fraction.

Commercial CDS

The commercial CDS is available to all institutions using the Epic electronic health record vendor, but violates some CDS design best practices, notably not being tailored to the end users of a given health system. The recommendation will be to initiate an evidence-based beta blocker for heart failure.

Group Type ACTIVE_COMPARATOR

Decision Support Systems, Clinical

Intervention Type OTHER

Active computerized clinical decision support alert within the electronic health record that recommends initiation of an evidence-based beta blocker for heart failure and reduced ejection fraction.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decision Support Systems, Clinical

Active computerized clinical decision support alert within the electronic health record that recommends initiation of an evidence-based beta blocker for heart failure and reduced ejection fraction.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CDS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Prescribing primary care clinicians at University of Colorado Health (UCHealth) who provide care for patients with heart failure and reduced ejection fraction

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Katy E Trinkley, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Colorado Health

Aurora, Colorado, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Trinkley KE, Kroehl ME, Kahn MG, Allen LA, Bennett TD, Hale G, Haugen H, Heckman S, Kao DP, Kim J, Matlock DM, Malone DC, Page Nd RL, Stine J, Suresh K, Wells L, Lin CT. Applying Clinical Decision Support Design Best Practices With the Practical Robust Implementation and Sustainability Model Versus Reliance on Commercially Available Clinical Decision Support Tools: Randomized Controlled Trial. JMIR Med Inform. 2021 Mar 22;9(3):e24359. doi: 10.2196/24359.

Reference Type DERIVED
PMID: 33749610 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19-0020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Heart Failure Medication Adherence
NCT03402750 COMPLETED NA