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An Implementation Model for Clinical Decision Support for Heart Failure Prescribing

Primary Purpose

Decision Support Systems, Clinical, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Support Systems, Clinical
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Decision Support Systems, Clinical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Customized CDS

Commercial CDS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in prescription of Beta blocker (BB)
Number of prescriptions of an evidence based BB during a primary care office visit.

Secondary Outcome Measures

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.
Clinician Adoption
The proportion of CDS who were not outright dismissed by the clinician.
Factors Influencing Clinician Adoption of the CDS per Qualitative Interviews
Clinician-reported factors that influence adoption of the CDS.

Full Information

First Posted
July 8, 2019
Last Updated
May 4, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04028557
Brief Title
An Implementation Model for Clinical Decision Support for Heart Failure Prescribing
Official Title
Development and Validation of an Integrated Implementation Model for Clinical Decision Support for Heart Failure Prescribing
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
September 23, 2019 (Actual)
Study Completion Date
September 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decision Support Systems, Clinical, Heart Failure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Customized CDS
Arm Type
Experimental
Arm Description
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.
Arm Title
Commercial CDS
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Decision Support Systems, Clinical
Other Intervention Name(s)
CDS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in prescription of Beta blocker (BB)
Description
Number of prescriptions of an evidence based BB during a primary care office visit.
Time Frame
6 months post CDS implementation
Secondary Outcome Measure Information:
Title
Patient Reach
Description
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.
Time Frame
6 months post CDS implementation
Title
Clinician Adoption
Description
The proportion of CDS who were not outright dismissed by the clinician.
Time Frame
6 months post CDS implementation
Title
Factors Influencing Clinician Adoption of the CDS per Qualitative Interviews
Description
Clinician-reported factors that influence adoption of the CDS.
Time Frame
6 months post CDS implementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katy E Trinkley, PharmD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33749610
Citation
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.
Results Reference
derived

Learn more about this trial

An Implementation Model for Clinical Decision Support for Heart Failure Prescribing

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