Mitral Regurgitation (MR)Echo PromptsNCT06816888
Impact of Automatic Prompts in Echocardiographic Reports on Referral to Cardiology
A study testing No Prompt, Prompt 1 and Prompt 2 in people with Mitral Regurgitation (MR) and Moderate or Severe Aortic Stenosis (AS) (Mean Pressure Gradient ≥ 20 mm Hg or Aortic Valve Area ≤ 1.5 cm2), run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation (MR), Moderate or Severe Aortic Stenosis (AS) (Mean Pressure Gradient ≥ 20 mm Hg or Aortic Valve Area ≤ 1.5 cm2)
- What is being tested?
- No Prompt, Prompt 1 and Prompt 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent provided
- 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)
- Patients referred by a non-cardiologist physician
- Patients not currently followed by a cardiologist or who have seen a cardiologist within 24 months prior to the TTE
Who cannot join
- Patients followed by a cardiologist or referred for a TTE by a Cardiologist
- Less than moderate AS and MR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Automatic Prompts in Echocardiographic Reports on Referral to Cardiology - A Randomized Control Study
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).
- Conditions
- Mitral Regurgitation (MR), Moderate or Severe Aortic Stenosis (AS) (Mean Pressure Gradient ≥ 20 mm Hg or Aortic Valve Area ≤ 1.5 cm2)
- Being tested
- No Prompt, Prompt 1, Prompt 2
- Keywords
- Echo prompts, valvular heart disease
- Medical subject headings
- Mitral Valve Insufficiency, Lymphoma, Follicular, Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No PromptOther
Presence and type of message included in the prompt will be randomized
Prompt 1Other
Presence and type of message included in the prompt will be randomized
Prompt 2Other
Presence and type of message included in the prompt will be randomized
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm 1 | Active comparator | 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." Receives: Other: Prompt 1 |
| Intervention arm 2 | Active comparator | 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". Receives: Other: Prompt 2 |
| Control arm | Placebo comparator | In this case no prompt will be added. Receives: Other: No Prompt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start30 Jan 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Regurgitation (MR)Studies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with 3 arms
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Messika-Zeitoun, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816888
- Sponsor's protocol ID
- 20240570-01H
- Acronym
- Echo Prompts
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Automatic Prompts in Echocardiographic Reports on Referral to Cardiology - A Randomized Control Study
- ClinicalTrials.gov ID
- NCT06816888
- Acronym / sponsor ID
- Echo Prompts / 20240570-01H
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled trial with 3 arms
| Arm | Type | Receives |
|---|---|---|
| Intervention arm 1 | Active comparator | Other: Prompt 1In this case, the prompt included will say "Your patient has been diagnosed with a moderate / severe valvular heart disease. Consider referral to a Cardiologist." |
| Intervention arm 2 | Active comparator | Other: Prompt 2In 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". |
| Control arm | Placebo comparator | Other: No PromptIn this case no prompt will be added. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consent provided
- 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)
- Patients referred by a non-cardiologist physician
- Patients not currently followed by a cardiologist or who have seen a cardiologist within 24 months prior to the TTE
Key exclusion criteria (2 listed)
- Patients followed by a cardiologist or referred for a TTE by a Cardiologist
- Less than moderate AS and MR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No PromptPresence and type of message included in the prompt will be randomized | Other | Control arm |
| Prompt 1Presence and type of message included in the prompt will be randomized | Other | Intervention arm 1 |
| Prompt 2Presence and type of message included in the prompt will be randomized | Other | Intervention arm 2 |
Primary outcome
Rate of referrals
Time frame: 6 months
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.
1 secondary outcome
Time interval
Time frame: At 6 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Messika-Zeitoun, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Prompt, Prompt 1 and Prompt 2 in people with Mitral Regurgitation (MR) and Moderate or Severe Aortic Stenosis (AS) (Mean Pressure Gradient ≥ 20 mm Hg or Aortic Valve Area ≤ 1.5 cm2), run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of referrals (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.