Automatic Prompts for Aortic Stenosis

(Echo Prompts Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Cardiologist follow-up, Less than moderate AS/MR

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Automatic Prompts for Aortic Stenosis?

The study on facilitated data relay shows that structured communication can improve the timeliness of treatment for severe aortic stenosis, suggesting that similar prompt-based interventions might enhance treatment outcomes by ensuring timely care. ^{1 2 3 4 5}

What is the purpose of this trial?

Echo Prompts study is a multi-center randomized controlled study to evaluate the impact of automatic prompts added to the conclusion of the echocardiographic reports of patient diagnosed with significant VHD 1) suggesting referral to a cardiologist or 2) suggesting referral to a cardiologist and offering the help of the University of Ottawa Heart Institute Center for Valvular Heart Diseases, compared to current standard of care (no prompts) on the rates and time to an evaluation by a cardiologist. We plan to involve a total of 300 patients in total. Primary endpoint will be the rate of referrals of patients having VHD to a cardiologist within 6 months after their TTE.

Research Team

David Messika-Zeitoun, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

This trial is for patients with heart valve conditions like Aortic Valve Stenosis or Mitral Regurgitation. Participants must have been diagnosed through echocardiography but haven't yet seen a cardiologist for these specific issues.

Inclusion Criteria

I haven't seen a cardiologist in the last 2 years.

Consent provided

I have been diagnosed with severe heart valve issues.

Exclusion Criteria

Less than moderate AS and MR

Patients followed by a cardiologist or referred for a TTE by a Cardiologist

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive echocardiographic reports with or without automatic prompts suggesting referral to a cardiologist

6 months

Follow-up

Participants are monitored for referral rates and time to cardiologist evaluation after receiving echocardiographic reports

6 months

Treatment Details

Interventions

• No Prompt
• Prompt 1
• Prompt 2

Trial Overview The study tests if adding automatic suggestions to echocardiogram reports affects how quickly and often patients see a heart specialist. There are three groups: no suggestion, one type of prompt, and another that includes help from a specialized center.

Participant Groups

Group I: Intervention arm 1 Active Control 1 Intervention

In this case, the prompt included will say "Your patient has been diagnosed with a moderate / severe valvular heart disease. Consider referral to a Cardiologist."

Group II: Intervention arm 2 Active Control 1 Intervention

In this case, the prompt included will say "Your patient has been diagnosed with a moderate /severe valvular heart disease. Consider referral to the UOHI Center for Valvular Heart Disease".

Group III: Control arm Placebo Group 1 Intervention

In this case no prompt will be added.

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Challenges in the management of severe asymptomatic aortic stenosis. [2011]

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

Early surgery or conservative management for asymptomatic severe aortic stenosis: Meta-analysis of RECOVERY and AVATAR. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Facilitated Data Relay and Effects on Treatment of Severe Aortic Stenosis in Europe. [2021]

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

A novel cardiovascular magnetic resonance risk score for predicting mortality following surgical aortic valve replacement. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Symptoms, disease severity and treatment of adults with a new diagnosis of severe aortic stenosis. [2020]