An Implementation Model for Clinical Decision Support for Heart Failure Prescribing

Overview

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.

Full Title of Study: “Development and Validation of an Integrated Implementation Model for Clinical Decision Support for Heart Failure Prescribing”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: September 23, 2019

Interventions

  • Other: 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in prescription of Beta blocker (BB)
    • Time Frame: 6 months post CDS implementation
    • Number of prescriptions of an evidence based BB during a primary care office visit.

Secondary Measures

  • Patient Reach
    • Time Frame: 6 months post CDS implementation
    • The proportion of unique patients with heart failure who were seen by primary care and not taking an evidence based BB who the CDS fired for.
  • Clinician Adoption
    • Time Frame: 6 months post CDS implementation
    • The proportion of CDS who were not outright dismissed by the clinician.
  • Factors Influencing Clinician Adoption of the CDS per Qualitative Interviews
    • Time Frame: 6 months post CDS implementation
    • Clinician-reported factors that influence adoption of the CDS.

Participating in This Clinical Trial

Study subjects are providers 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Katy E Trinkley, PharmD, Principal Investigator, University of Colorado, Denver

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