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

Primary Purpose

Coronary Artery Calcification

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Notification
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Calcification

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Notification

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of new statin prescriptions or increased dose prescriptions
6-month new statin prescription rate or increase in dosage if baseline statin use

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2022
Last Updated
May 5, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05588895
Brief Title
Picture of Incidental Calcium To Understand Risk Estimate (PICTURE) Trial
Acronym
PICTURE
Official Title
NOTIFY 2: Picture of Incidental Calcium To Understand Risk Estimate
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Calcification

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Notification
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Notification
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of new statin prescriptions or increased dose prescriptions
Description
6-month new statin prescription rate or increase in dosage if baseline statin use
Time Frame
Baseline through Month 6
Secondary Outcome Measure Information:
Title
Number of participants using statin medication
Description
6-month assessment of statin prescription rates/dose
Time Frame
Month 6
Title
Change in Low-density lipoprotein (LDL) cholesterol
Time Frame
Baseline and Month 6
Title
Change in 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Pooled Cohort Equation
Description
This outcome measures the 10 year risk of ASCVD events.
Time Frame
Baseline and Month 6
Title
Number of events requiring primary care intervention, cardiology referrals, or cardiac testing
Description
This outcome assesses healthcare resource use (primary care clinical encounters, cardiology referrals, cardiac testing).
Time Frame
Baseline through Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatima Rodriguez, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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