Notify 2: An Evaluation of the Impact of Notification of Incidental Coronary Artery Calcium on Statin Rates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-03-15

Brief Summary

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The primary objective is to estimate the impact of notification of primary care provider and patient of at least moderate incidental coronary artery calcification (CAC) on a prior non-gated chest CT on statin prescription rates at 4 months among patients without a clinical history of atherosclerotic cardiovascular disease not actively on statin therapy. This study will determine if notifying patients and their primary care clinician about an existing finding will influence shared decision-making around statins between patients and their primary care clinician.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Notification

Notification of the presence of at least moderate coronary artery calcium on a prior non-gated chest CT

Group Type EXPERIMENTAL

Notification

Intervention Type OTHER

Notification of patient and primary care clinician of presence of at least moderate coronary artery calcium on a prior non-gated chest CT

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Notification

Notification of patient and primary care clinician of presence of at least moderate coronary artery calcium on a prior non-gated chest CT

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age greater than or equal to 18 and less than 85
2. Non-gated chest CT from 1/1/2016-6/30/2020 with algorithm screening estimating CAC score of at least 100 Agatston Units with radiologist confirmation of moderate or severe CAC
3. Encounter with Palo Alto VA affiliated primary care since 2020

Exclusion Criteria

1. Prior diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
2. Dementia
3. Metastatic cancer or active cancer undergoing chemotherapy
4. CT coronary angiogram since 2016
5. Invasive Coronary angiogram since 2016
6. CAC scan since 2016
7. Statin therapy within prior 6 months
8. Prior ezetimibe or PCSK9 inhibitor therapy
9. Prior rhabdomyolysis with statin therapy
10. Schizophrenia
11. Substance abuse disorder (alcohol, amphetamines, cocaine, opioids)
12. Hospice
13. Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No