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Active, not recruitingNCT06816888Echo PromptsUpdated Apr 30, 2026

Impact of Automatic Prompts in Echocardiographic Reports on Referral to Cardiology

An interventional study of No Prompt and Prompt 1 in Mitral Regurgitation (MR) and Moderate or Severe Aortic Stenosis (AS) (Mean Pressure Gradient ≥ 20 mm Hg or Aortic Valve Area ≤ 1.5 cm2), sponsored by Ottawa Heart Institute Research Corporation. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Ottawa Heart Institute Research Corporation · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Valvular heart disease (VHD) is next epidemic in the cardiovascular field, affecting millions of people worldwide and having a major impact on health care systems. With aging of the population, the incidence and prevalence of VHD will continue to increase.1-3 There is no medication that can prevent VHD progression. Appropriate management of patients with VHD relies on 3 pillars, early diagnosis, careful follow-up, and timely intervention. Regular follow-up by cardiologists and implementation of specialized VHD clinics have demonstrated a beneficial effect on patients' outcomes. 4Unfortunately, multiple studies have shown that patients with VHD remain undertreated and referred late in the course of the disease with inequality in access to care and treatment options. 5-12 Late presentation is associated with major penalties for patients who incur an increased risk of mortality and morbidity not restored even by a successful intervention. 13-17 In a community-based study collecting all consecutive patients diagnosed with moderate or severe mitral regurgitation (MR) based on echocardiography, only 15% were referred to surgery despite a clear (class I) indication for intervention. 18 These findings are even more remarkable as all patients were diagnosed with an echocardiogram performed at the Mayo Clinic, they had access to a world renown institution capable of achieving excellent surgical outcomes and there were no health care coverage issues. Potential reasons explaining the late referral and undertreatment of patients with VHD are insufficient physicians' knowledge regarding the management and timing of intervention, misbelief regarding the risk/benefit ratio of valvular interventions, incomplete understanding of the echocardiogram reports and limited access to cardiologists and more specifically to VHD specialists. 19, 20 We hypothesize that highlighting the importance of valvular echocardiographic findings to the ordering (non-cardiologist) physicians in an easy and comprehensive wording and offering access to cardiologists specialized in VHD will improve patients' referral rates to cardiologist and ultimately patients' outcomes. Implementation of prompts into clinical reports in various settings including VHD has been advocated but formal demonstration of its efficacy is lacking.

In this randomized controlled study, we will 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. This study will enable us to assess the impact of diagnostic prompts in isolation and associated to a facilitated access to VHD experts compared to our current practice.

This study is being conducted to see if addition of a prompt will increase the rate of patients seen by a cardiologist within 6 months after the TTE by 20% (absolute increase).

02

Conditions studied

  • Mitral Regurgitation (MR)
  • Moderate or Severe Aortic Stenosis (AS) (Mean Pressure Gradient ≥ 20 mm Hg or Aortic Valve Area ≤ 1.5 cm2)

Keywords

  • Echo prompts
  • valvular heart disease
03

In context

Mitral Valve Insufficiency

459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.

This study's enrollment of 300 is above the median of 61 across 274 interventional studies indexed under Mitral Valve Insufficiency.

Browse Mitral Valve Insufficiency studies →

Lead sponsor

Ottawa Heart Institute Research Corporation is the lead sponsor of 179 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Consent provided
  2. Patients diagnosed with moderate or severe aortic stenosis (AS) (mean pressure gradient ≥ 20 mm Hg or aortic valve area ≤ 1.5 cm2) or mitral regurgitation (MR) (based on integrative approach)
  3. Patients referred by a non-cardiologist physician
  4. Patients not currently followed by a cardiologist or who have seen a cardiologist within 24 months prior to the TTE

Exclusion criteria

Exclusion Criteria:

  1. Patients followed by a cardiologist or referred for a TTE by a Cardiologist
  2. Less than moderate AS and MR
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Active comparator
    Intervention arm 1

    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."

    Other: Prompt 1

  • Active comparator
    Intervention arm 2

    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".

    Other: Prompt 2

  • Placebo comparator
    Control arm

    In this case no prompt will be added.

    Other: No Prompt

Interventions

  • OtherNo Prompt

    Presence and type of message included in the prompt will be randomized

  • OtherPrompt 1

    Presence and type of message included in the prompt will be randomized

  • OtherPrompt 2

    Presence and type of message included in the prompt will be randomized

06

What researchers measure

Primary outcomes

  1. Rate of referrals

    The primary outcome measure of this study will be to compare the rates of patients seen by a cardiologist with 6 months between the 3 arms.

    Time frame: 6 months

Secondary outcomes

  1. Time interval

    To compare the time interval in days between TTE and visit to a cardiologist between the 3 arms.

    Time frame: At 6 months after enrollment

07

Study locations

1 site
  • University of Ottawa Heart Institute
    Ottawa, Ontario K1Y 4W7, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06816888
Lead sponsor
Ottawa Heart Institute Research Corporation
Responsible party
Sponsor
First posted
Feb 10, 2025
Start date
Jan 30, 2025
Primary completion
Dec 1, 2026 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Apr 30, 2026

Study contacts

David Messika-Zeitoun, MD
principal investigator · Ottawa Heart Institute Research Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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