An Implementation Model for Clinical Decision Support for Heart Failure Prescribing

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04028557
• Other study ID #: 19-0020
• Status: Completed
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: September 23, 2019

Study information

• Verified date: May 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: September 23, 2019
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Decision Support Systems, Clinical
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Health	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Clinician Adoption	The proportion of CDS who were not outright dismissed by the clinician.	6 months post CDS implementation
Secondary	Factors Influencing Clinician Adoption of the CDS per Qualitative Interviews	Clinician-reported factors that influence adoption of the CDS.	6 months post CDS implementation