Notification for Coronary Artery Calcification

(PICTURE Trial)

Overseen By Shiqin Xu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Statins, Non-statin lipid-lowering

Disqualifiers: Advanced cancer, No active care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

202 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on statin or non-statin lipid-lowering therapy, you are not eligible to participate.

What data supports the effectiveness of the treatment Notification for Coronary Artery Calcification?

The research suggests that using automated notification systems can improve communication of critical test results, which may enhance patient safety and reduce errors. While not directly related to coronary artery calcification, these systems have been effective in ensuring timely communication of important medical information. ^{1 2 3 4 5}

Research Team

Fatima Rodriguez, MD

Principal Investigator

Stanford University

Eligibility Criteria

The PICTURE trial is for adults aged 18 to under 85 who've had a non-gated chest CT scan showing coronary artery calcification, and have seen a Stanford-affiliated clinician since January 1, 2020. It's not for those already on cholesterol-lowering meds, with advanced cancer, without active primary care at Stanford Health Care, outside the age range, or with statin allergies.

Inclusion Criteria

Chest CT scan without calcium scoring.

You saw a doctor at Stanford Internal Medicine, Stanford Family Medicine, or a non-EP cardiologist after January 1, 2020.

Exclusion Criteria

My cancer is in an advanced stage or has a poor outlook.

No active primary care at Stanford Health Care

Non-English or non-Spanish speaking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Notification

Eligible patients are randomized to either CAC notification or usual care. Notification involves sending a standardized message to the patient's clinician and, after a delay, to the patient.

2 weeks

Follow-up

Participants are monitored for changes in statin prescription rates and healthcare resource use.

6 months

Treatment Details

Interventions

• Notification

Trial Overview This study tests whether notifying patients and their doctors about incidental findings of heart artery calcification from chest CT scans affects cardiovascular risk management. Participants are randomly placed into two groups: one receives notification of their CAC results; the other continues usual care without specific notification.

Participant Groups

Group I: Notification Experimental Treatment 1 Intervention

The notification arm will have its CT scans interpreted and reported according to standard clinical practice. A standardized notification message using the EHR will be sent to the patient's Stanford affiliated non-EP cardiologist, if present, or the primary care clinician if there is no non-EP cardiologist. After a two week delay from notifying the patient's non-EP cardiologist or PCP, a standardized notification message will be sent to the patient. The message will include an image of the CAC from the chest CT. All communications will be signed by the Principal Investigator. Any treatment decisions will be made by the patient and their clinician.

Group II: Usual Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

An automated email notification system was implemented to inform physicians about finalized test results pending at discharge (TPADs), improving communication and responsibility transfer between inpatient and primary care physicians.

During a 6-month pilot involving randomly selected inpatient-attending physicians, 84% reported satisfaction with the system, indicating its effectiveness in managing TPADs with an average of 1.6 notifications per discharged patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of an automated email notification system for results of tests pending at discharge. Dalal, AK., Schnipper, JL., Poon, EG., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Communication outcomes of critical imaging results in a computerized notification system. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Providers Electing to Receive Electronic Result Notifications: Demographics and Motivation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Frequency of failure to inform patients of clinically significant outpatient test results. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Design and implementation of an automated email notification system for results of tests pending at discharge. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Automated critical test result notification system: architecture, design, and assessment of provider satisfaction. [2021]