An Implementation Model for Clinical Decision Support for Heart Failure Prescribing

Development and Validation of an Integrated Implementation Model for Clinical Decision Support for Heart Failure Prescribing

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Decision Support Systems, Clinical
• Intervention / Treatment: Other: Decision Support Systems, Clinical

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: CDS
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.	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.; Other Names: CDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reach	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.	6 months post CDS implementation
Clinician Adoption	The proportion of CDS who were not outright dismissed by the clinician.	6 months post CDS implementation
Factors Influencing Clinician Adoption of the CDS per Qualitative Interviews	Clinician-reported factors that influence adoption of the CDS.	6 months post CDS implementation

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Katy E Trinkley, PharmD, University of Colorado, Denver

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): September 23, 2019
• Study Completion (Actual): September 23, 2019

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 19-0020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No