Impact of Automatic Prompts in Echocardiographic Reports on Referral to Cardiology

NCT06816888 | Active Not Recruiting

• 1 other identifier: 20240570-01H
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

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.

  6 months

Secondary Outcomes (1)

• Time interval

  At 6 months after enrollment

Study Arms (3)

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."

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".

Other: Prompt 2

Control arm

PLACEBO COMPARATOR

In this case no prompt will be added.

Other: No Prompt

Interventions

No Prompt OTHER

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

Control arm

Prompt 1 OTHER

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

Intervention arm 1

Prompt 2 OTHER

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

Intervention arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Lymphoma, Follicular; Aortic Valve Stenosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction

Study Officials

• David Messika-Zeitoun, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with 3 arms

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 10, 2025
• Study Start: January 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CA (1)