- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06277323
UCLA Health Patient Cardiology Care Gaps
This is a prospective randomized clinical trial evaluating how two behaviorally-informed interventions (i.e., monthly report card and storyboard interventions) impact physician behavior, with the goal of closing care gaps in preventive care and disease management.
In particular, the monthly report card intervention seeks to elevate physicians' intentions to close their patients' care gaps, while the storyboard intervention seeks to prompt action by making patients' care gaps salient. The trial investigates the separate and joint impacts of the proposed behaviorally-informed interventions on encouraging physicians to close their patients' care gaps.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Despite the existence of evidence-based clinical guidelines on how to manage the health of patients with cardiovascular disease that have been shown to improve cardiac function and survival, significant gaps in care persist and optimal medical therapy is often under-utilized. For example, guideline-directed medical therapy (GDMT), statin and aspirin therapy, and blood pressure control are cornerstones of effective management of patients with cardiovascular disease or heart failure. However, current dashboard data indicate that within the UCLA Health system, these medical therapies remain under-utilized.
As part of the quality improvement (QI) initiative sponsored by the Division of Cardiology at UCLA Health, this trial will examine the independent and joint impacts on care gap closure of (1) sending monthly behaviorally-informed emails to physicians with personalized feedback on care gap performance and (2) enhancing the visibility of the open care gaps in the electronic health record upon patient encounter.
Eligible physicians (i.e., UCLA Health Cardiologists) will be randomized to one of four conditions based on a 2 (monthly report card intervention: receive vs. no receive) x 2 (storyboard intervention: receive vs not receive) between-subjects design:
- In the no intervention (control) condition, physician participants will receive quarterly emails with their performance report card (status quo).
- In the monthly report card only condition, behaviorally-informed monthly emails will be sent to inform physicians of their performance and elevate physicians' intentions to get more of their patients to close care gaps.
- In the storyboard only condition, the visibility of care gap banners in the electronic health record (EHR) will be enhanced, which will promptly remind physicians of each patient's care gaps at the start of a patient-physician encounter.
- In the monthly report card and storyboard condition, physicians will receive behaviorally-informed monthly emails and be reminded of each patient's care gaps via the EHR storyboard during patient-physician encounters.
The trial will include physicians participating in an existing UCLA incentive program, as of October 1, 2023, who have a panel size of above 50 patients. In August 2024, new physicians who are eligible for the incentive program and have at least 50 patients in the panel will be randomly assigned into one of the four conditions and become part of the study sample. Randomization will balance for physicians' baseline performance, subspecialty training, years out from training, and estimated panel size.
Monthly performance feedback emails will include physicians' performance on eight cardiology care gaps, their projected earnings in the current quarter and their earnings in the previous quarter. Care gaps include the following: (1) statin or PCSK9 inhibitor use, (2) aspirin use, (3) beta blocker use, (4) angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, or angiotensin receptor-neprilysin inhibitor use, (5) mineralocorticoid receptor antagonist use, (6) SGLT2i, (7) average HCC/RAF score, and (8) blood pressure control.
Analysis Plan:
- The investigators will use patient-level linear regression models, where the response is a 1/0 indicator of whether the patient has completed any of the open care gaps, with cluster-robust standard errors at the physician level.
- The primary regression model will look at the main effect of the report card intervention and the storyboard intervention.
- In a secondary regression, we will investigate the joint impact of the two interventions, including a report card x storyboard interaction.
Control variables include:
- Patient-level care gap closure (i.e., whether patients closed any of their open care gaps, excluding HCC/RAF score, during the six months before the intervention delivery). For patients who were not in a given physician's panel as of six months before the experiment, mean values across the panel will be imputed.
- Physician characteristics (gender, years out from training, subspecialty training within cardiology) and panel size.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA Health Department of Medicine, Quality Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Cardiologists who practice at one or more UCLA Health sites in the outpatient setting
- Enrolled in the pre-existing cardiology financial incentive program at UCLA Health
- With patient panel size above 50
Exclusion criteria:
- Cardiologists who were involved in the design of the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Arm 1: Quarterly performance email (current state, control condition)
Eligible, randomly assigned physicians will receive status quo quarterly emails with their performance report card.
|
|
Experimental: Arm 2: Monthly report card only
Eligible, randomly assigned physicians will receive behaviorally-informed monthly emails (monthly performance report card) intended to elevate their intentions to improve their performance (i.e., getting more of their patients to close care gaps).
|
The investigators will increase the frequency (monthly instead of quarterly) and enhance the content of the performance feedback emails sent to cardiologists (i.e., behaviorally-informed).
|
Experimental: Arm 3: Storyboard only
Eligible, randomly assigned physicians will receive status quo quarterly emails and get a more visible care gap banner in the electronic health record (EHR), intended to promptly remind them of each patient's care gaps at the start of a patient-physician encounter.
|
The visibility of the care gap banner in the electronic health record (EHR) upon patient encounter will be enhanced.
|
Experimental: Arm 4: Monthly report card AND Storyboard
Eligible, randomly assigned physicians will receive behaviorally-informed monthly emails and get a more visible care gap banner in the electronic health record (EHR) upon patient encounter.
|
The investigators will increase the frequency (monthly instead of quarterly) and enhance the content of the performance feedback emails sent to cardiologists (i.e., behaviorally-informed).
The visibility of the care gap banner in the electronic health record (EHR) upon patient encounter will be enhanced.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Care gap closure (patients seen)
Time Frame: 6 months after each patient's first encounter with the physician during the first 12 months of the intervention period
|
Whether a patient completed any of the following seven care gaps will be tracked for each patient who visits a physician during the first 12 months of the intervention period: (1) statin or PCSK9 inhibitor use, (2) aspirin use, (3) beta blocker use, (4) angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, or angiotensin receptor-neprilysin inhibitor use, (5) mineralocorticoid receptor antagonist use, (6) SGLT2i use, and (7) blood pressure control.
|
6 months after each patient's first encounter with the physician during the first 12 months of the intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Care gap closure (all patients in panel)
Time Frame: 12 months after the intervention starts (for existing patients) or 12 months since patients join the panel (for patients who join during the first six months of the experiment)
|
Whether a patient completed any of the following seven care gaps will be tracked for each patient who is in a physician's panel during the first six months of the intervention period: (1) statin or PCSK9 inhibitor use, (2) aspirin use, (3) beta blocker use, (4) angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, or angiotensin receptor-neprilysin inhibitor use, (5) mineralocorticoid receptor antagonist use, (6) SGLT2i use, and (7) blood pressure control.
|
12 months after the intervention starts (for existing patients) or 12 months since patients join the panel (for patients who join during the first six months of the experiment)
|
Number of care gaps closed (patients seen)
Time Frame: 6 months after each patient's first encounter with the physician during the first 12 months of the intervention period
|
The number of care gaps closed will be tracked for each patient who visits a physician during the first 12 months of the intervention period, considering the following seven care gaps: (1) statin or PCSK9 inhibitor use, (2) aspirin use, (3) beta blocker use, (4) angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, or angiotensin receptor-neprilysin inhibitor use, (5) mineralocorticoid receptor antagonist use, (6) SGLT2i use, and (7) blood pressure control.
The investigators will also analyze the number of care gaps closed when excluding care gap (7) blood pressure control.
|
6 months after each patient's first encounter with the physician during the first 12 months of the intervention period
|
Number of care gaps closed (all patients in panel)
Time Frame: 12 months after the intervention starts (for existing patients) or 12 months since patients join the panel (for patients who join during the first six months of the experiment)
|
The number of care gaps closed will be tracked for each patient who is in a physician's panel during the six months of the intervention period, considering the following seven care gaps: (1) statin or PCSK9 inhibitor use, (2) aspirin use, (3) beta blocker use, (4) angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, or angiotensin receptor-neprilysin inhibitor use, (5) mineralocorticoid receptor antagonist use, (6) SGLT2i use, and (7) blood pressure control.
The investigators will also analyze the proportion of care gaps closed when excluding care gap (7) blood pressure control.
|
12 months after the intervention starts (for existing patients) or 12 months since patients join the panel (for patients who join during the first six months of the experiment)
|
HCC/RAF care gap closure (all patients in panel)
Time Frame: 12 months after the intervention starts (for existing patients) or 12 months since patients join the panel (for patients who join during the first six months of the experiment)
|
Whether HCC/RAF coding was completed will be tracked for each patient that is in a physician's panel during the first 12 months of the intervention period.
|
12 months after the intervention starts (for existing patients) or 12 months since patients join the panel (for patients who join during the first six months of the experiment)
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Cardio
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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