An Implementation Model for Clinical Decision Support for Heart Failure Prescribing

NCT04028557 | Completed

• 1 other identifier: 19-0020
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Decision Support Systems, Clinical; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in prescription of Beta blocker (BB)

  Number of prescriptions of an evidence based BB during a primary care office visit.

  6 months post CDS implementation

Secondary Outcomes (3)

• Patient Reach

  6 months post CDS implementation

• Clinician Adoption

  6 months post CDS implementation

• Factors Influencing Clinician Adoption of the CDS per Qualitative Interviews

  6 months post CDS implementation

Study Arms (2)

Customized CDS

EXPERIMENTAL

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.

Other: Decision Support Systems, Clinical

Commercial CDS

ACTIVE COMPARATOR

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.

Other: Decision Support Systems, Clinical

Interventions

Decision Support Systems, Clinical 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.

Also known as: CDS

Commercial CDS; Customized CDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Health

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 33749610 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Katy E Trinkley, PharmD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 22, 2019
• Study Start: June 24, 2019
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)