An Implementation Model for Clinical Decision Support for Heart Failure Prescribing

Study Overview
=================
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.

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

Conditions
-----------------
Decision Support Systems, Clinical, Heart Failure

Intervention / Treatment
-----------------
* Other: Decision Support Systems, Clinical


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Customized CDS<br>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<br>* 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.<br>* Other names: CDS;|
| Active Comparator: Commercial CDS<br>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<br>* 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.<br>* 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 |