Picture of Incidental Calcium To Understand Risk Estimate (PICTURE) Trial

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05588895

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective randomized controlled trial assessing the impact of notifying patients and their clinicians of an incidental finding of coronary artery calcification (CAC) indicating increased cardiovascular risk. Patients will be identified through completed radiology orders for non-gated, non-contrast chest CT in the appropriate clinical context and then will have an EHR screen for inclusion criteria. The presence of CAC will be confirmed by a board-certified physician. Eligible patients will be randomized to CAC notification or usual care using a 1:1 stratified block randomization method based on baseline statin use.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Calcification	Other: Notification	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

NOTIFY 2: Picture of Incidental Calcium To Understand Risk Estimate

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Notification The notification arm will have its CT scans interpreted and reported according to standard clinical practice. Patients randomized to notification will receive a message sent by either the EHR patient portal or postal mail that will inform them of the CAC identified on their recent chest CT. It will provide an overview of CAC, an image of their chest CT, and current guideline recommendation that they discuss this finding with their clinician and consider statin therapy. A patient's primary care physician will be notified simultaneously via a secure EHR message. All communications will be signed by the Principal Investigator. Any treatment decisions will be made by the patient and their clinician.	Other: Notification For patients randomized to notification, the affiliated primary care clinician will receive an electronic health record (EHR) message notifying them of the presence of CAC (with images) and the ACC/AHA guideline recommendation to consider starting statin therapy. Simultaneously, the patient will be notified via a MyHealth message describing the presence of CAC with personalized scan images, its significance, and the recommendation that statin therapy should be considered. For the notification arm, we will check for either statin prescription or a documented discussion in the EHR at 2 months. For those not prescribed a statin and without a documented discussion in Epic at 2 months follow-up, we will send a repeat notification to their home address and to their primary care clinician.
No Intervention: Usual Care The usual care arm will have its CT scans interpreted and reported according to standard clinical practice. This may mention the presence of CAC in the official radiology imaging report, per usual practice. The usual care arm will not receive any notification beyond this standard of care. We intend to notify patients in the usual care arm at the end of 6 months if we determine that notification is effective at increasing statin rates.

Arm

Intervention/Treatment

Experimental: Notification

The notification arm will have its CT scans interpreted and reported according to standard clinical practice. Patients randomized to notification will receive a message sent by either the EHR patient portal or postal mail that will inform them of the CAC identified on their recent chest CT. It will provide an overview of CAC, an image of their chest CT, and current guideline recommendation that they discuss this finding with their clinician and consider statin therapy. A patient's primary care physician will be notified simultaneously via a secure EHR message. All communications will be signed by the Principal Investigator. Any treatment decisions will be made by the patient and their clinician.

Other: Notification

For patients randomized to notification, the affiliated primary care clinician will receive an electronic health record (EHR) message notifying them of the presence of CAC (with images) and the ACC/AHA guideline recommendation to consider starting statin therapy. Simultaneously, the patient will be notified via a MyHealth message describing the presence of CAC with personalized scan images, its significance, and the recommendation that statin therapy should be considered. For the notification arm, we will check for either statin prescription or a documented discussion in the EHR at 2 months. For those not prescribed a statin and without a documented discussion in Epic at 2 months follow-up, we will send a repeat notification to their home address and to their primary care clinician.

No Intervention: Usual Care

The usual care arm will have its CT scans interpreted and reported according to standard clinical practice. This may mention the presence of CAC in the official radiology imaging report, per usual practice. The usual care arm will not receive any notification beyond this standard of care. We intend to notify patients in the usual care arm at the end of 6 months if we determine that notification is effective at increasing statin rates.

Outcome Measures

Primary Outcome Measures

Number of new statin prescriptions or increased dose prescriptions [Baseline through Month 6]
6-month new statin prescription rate or increase in dosage if baseline statin use

Secondary Outcome Measures

Number of participants using statin medication [Month 6]
6-month assessment of statin prescription rates/dose
Change in Low-density lipoprotein (LDL) cholesterol [Baseline and Month 6]
Change in 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Pooled Cohort Equation [Baseline and Month 6]
This outcome measures the 10 year risk of ASCVD events.
Number of events requiring primary care intervention, cardiology referrals, or cardiac testing [Baseline through Month 6]
This outcome assesses healthcare resource use (primary care clinical encounters, cardiology referrals, cardiac testing).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 and above and <90
Non-gated chest CT with CAC
An encounter after January 1, 2020 with a Stanford-affiliated clinician from one of the following clinics:
Stanford Internal Medicine (includes University affiliated clinics)
Stanford Family Medicine (includes University affiliated clinics)

Exclusion Criteria:

Metastatic cancer or active cytotoxic chemotherapy
Non-English or non-Spanish speaking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Fatima Rodriguez, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fatima Rodriguez, Assistant Professor of Medicine (Cardiovascular Medicine), Stanford University

ClinicalTrials.gov Identifier:

NCT05588895

Other Study ID Numbers:

67227

First Posted:

Oct 20, 2022

Last Update Posted:

Oct 20, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Calcinosis

Study Results

No Results Posted as of Oct 20, 2022