TITLE: The HIDDEN ASCVD Study
INVESTIGATORS:
Alex Sandhu (1)
Andrew Ambrosy (2)
Fatima Rodriguez (1)
(1) Cardiovascular Medicine, Stanford
(2) Cardiology, Kaiser Medical Center San Francisco
DATE: Wednesday, 3 May 2023
TIME: 1:30–3:00 PM
LOCATION: Conference Room X399, Medical School Office Building, 1265 Welch Road, Stanford, CA
ABSTRACT
The Data Studio Workshop brings together a biomedical investigator with a group of experts for an in-depth session to solicit advice about statistical and study design issues that arise while planning or conducting a research project. This week, the investigator(s) will discuss the following project with the group.
BACKGROUND
Coronary artery calcium (CAC) is the strongest predictor of myocardial infarction (MI). The knowledge of having CAC is a powerful motivator of preventive behavior; this includes the initiation of statin therapy, which has been shown to reduce the risk of atherosclerotic cardiovascular disease (ASCVD) events by 25%. However, <10% of potentially eligible patients receive gated computed tomography (CT) scans to measure CAC. Furthermore, historically marginalized populations undergo even fewer gated CAC scans. CAC can be identified on the 19 million non-gated chest CTs performed annually. In the NOTIFY-1 pilot trial of 176 patients, notification of patients and primary care clinicians of the presence of incidental CAC increased statin prescription rates to 51% compared with 7% in the standard of care arm.
INTRODUCTION
We are submitting an R01 to the NHLBI on a pragmatic adaptive clinical trial in which we are testing different strategies for notifying patients regarding an incidental finding of coronary calcium. We are hoping to adapt the notification strategy to identify the notification approach that most effectively increases medication rates (statin prescription 3 months after notification) and minimizes patient anxiety. Increasing statin initiation among patients with incidental CAC could prevent approximately 500,000 ASCVD events over a decade. However, there are significant knowledge gaps that must be addressed: insights into the incidental CAC notification design that both effectively increases statin rates and is preferable to patients. We propose answering this question using an adaptive RCT conducted within Kaiser Permanente Northern California (KPNC), an integrated health care delivery system providing care to >4.5 million members with broad age, sex, racial, and ethnic diversity. The HIDDEN ASCVD study has the potential to be paradigm shifting by identifying the optimal behavior theory-driven notification strategy for statin therapy. Following this project, effective scaling of opportunistic CAC screening and notification will lead to reduction in ASCVD burden overall, particularly among historically marginalized populations.
HYPOTHESIS-AIM-OBJECTIVE
Our hypothesis is that certain notification strategies (e.g., based on the messenger, the positive/negative framing, etc.) are more effective than others at increasing statin rates and lead to less patient anxiety. Our aim is to compare the effect of multiple behavioral theory-driven incidental CAC notification strategies on rates of statin therapy initiation via an adaptive RCT. We will prospectively identify individuals with incidental CAC without known ASCVD not receiving statin therapy within KPNC. Individuals will be assigned randomly to notification strategies that are modifications of the initial strategy used in the NOTIFY-1 pilot study. Modifications will be based on the MINDSPACE behavioral change framework. Through an adaptive design, the objective will be to design the most effective notification that promotes statin initiation and is acceptable to patients and primary care clinicians.
STUDY POPULATION
The study cohort will be enriched for historically marginalized racial and ethnic groups.
OUTCOMES
The primary outcome will be statin initiation with the key secondary outcome being anxiety related to the notification based on PROMIS Anxiety Short Form.
STRATEGY-TEAM
The HIDDEN-ASCVD study will apply an adaptive RCT grounded in behavioral change theory to evaluate notification strategies and identify the ideal balance between motivating behavioral change and minimizing unnecessary patient anxiety. Our multidisciplinary team brings together early stage investigators (ESIs) and senior scientific leaders from the KPNC Division of Research and Stanford University with expertise in ASCVD prevention, health equity, predictive analytics, delivery science, and RCTs. The clinical coordination will be centered at Kaiser with the analysis planned at Stanford.
SAMPLE SIZE
We are imagining six (6) phases of 6-months each with approximately 800 patients for a total sample of 4800 individuals.
STATISTICAL QUESTIONS
We have a preliminary design and sample size. We need help thinking through the design and need a co-investigator for the award.
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