Impact of Automatic Prompts in Echocardiographic Reports on Referral to Cardiology (Echo Prompts)

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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."
Presence and type of message included in the prompt will be randomized
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".
Presence and type of message included in the prompt will be randomized
Placebo Comparator: Control arm
In this case no prompt will be added.
Presence and type of message included in the prompt will be randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time interval
Time Frame: At 6 months after enrollment
To compare the time interval in days between TTE and visit to a cardiologist between the 3 arms.
At 6 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David Messika-Zeitoun, MD, Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mitral Regurgitation (MR)

Clinical Trials on Prompt 1

Subscribe