- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06816888
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients followed by a cardiologist or referred for a TTE by a Cardiologist
- Less than moderate AS and MR
Study Plan
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
Investigators
- Principal Investigator: David Messika-Zeitoun, MD, Ottawa Heart Institute Research Corporation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Aortic Valve Disease
- Cardiovascular Diseases
- Neoplasms
- Heart Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Ventricular Outflow Obstruction
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Hemic and Lymphatic Diseases
- Aortic Valve Stenosis
- Lymphoma, Follicular
- Mitral Valve Insufficiency
- Heart Valve Diseases
Other Study ID Numbers
- 20240570-01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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