A Multi-centered Feedback and Education Intervention Designed to Reduce Inappropriate Transthoracic Echocardiograms

June 7, 2016 updated by: Women's College Hospital

Feedback and Education Intervention to Reduce Inappropriate Transthoracic Echocardiograms (TTE)

This study is an international, prospective, multi-centred, investigator blinded, randomized control trial of an educational and feedback-based intervention vs. usual care to study the proportion of inappropriate TTEs ordered by clinicians in ambulatory care.

The American College of Cardiology collaborated with the American Society of Echocardiography to develop its Appropriate Use Criteria (AUC) for Echocardiography in 2007, and were updated in 2011.

We created an innovative education and feedback-based intervention that we hypothesize will reduce the proportion of inappropriate TTEs ordered in clinical practice. Our objective is to prospectively study the following intervention in a multicentre, randomized control trial format to determine if this intervention will reduce inappropriate TTEs and the number of TTEs ordered in practice.

The study will take place at multiple hospitals in Canada the United States. Participants include cardiologists and primary care providers (both general internal medicine and family practice) who provide ambulatory care.

Once cardiologists and primary care physicians are recruited for the study, they will be randomized into one of two arms: 1) Intervention group, 2) Control group.

A physician's TTE ordering information will be ascertained by review of the individual TTE order and by review of the patient's medical record. Trained research coordinators at each site will review the TTE order for indication and review the patient record to ascertain clinical circumstances regarding the TTE order. The individual research coordinator will review this information using the 2011 AUC and classify the TTE as Appropriate (A), Inappropriate (I) or Uncertain (U), and assign the TTE order the most appropriate indication number accordingly. Research Coordinators will be blinded to which physicians are in the intervention or control group.

Research Coordinators at each site will be responsible for individual physicians' TTE order classifications but will be blinded to study group. Once monthly TTE orders are classified and collated, this information will be transmitted to the central research laboratory, where a research coordinator will collate all of the results and transmit monthly feedback reports to individual physicians. The control group will order TTEs as is their usual practice.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is an international, prospective, multi-centred, investigator blinded, randomized control trial of an educational and feedback-based intervention vs. usual care to study the proportion of inappropriate TTEs ordered by clinicians in ambulatory care.

Increased inappropriate TTE utilization represents a burden to health budgets as costs rise with increased utilization, and to patients themselves who are burdened with unnecessary procedures that can adversely affect quality of care. Rising utilization in an environment with limited supply also creates barriers to access and increased wait times for those patients in the community who are awaiting necessary TTEs.

In a move to balance the concern regarding rising utilization while still ensuring physician autonomy on access to ordering cardiac tests and procedures, the American College of Cardiology collaborated with the American Society of Echocardiography to develop its Appropriate Use Criteria (AUC) for Echocardiography in 2007, and were updated in 2011. AUC were created by using the modified RAND appropriateness method. Studies applying AUC to TTE orders at single centres in the US found inappropriate TTE rates in ambulatory (outpatient) care ranging up to 35%.

We have successfully created an innovative education and feedback-based intervention that we hypothesize will reduce the proportion of inappropriate TTEs ordered in clinical practice, which will save healthcare dollars and improve quality of care and access to echocardiography. Our objective is to prospectively study the following intervention in a multicentre, randomized control trial format to determine if this intervention will reduce inappropriate TTEs and the number of TTEs ordered in practice.

The study will take place at multiple hospitals in Canada the United States. Participants include cardiologists and primary care providers (both general internal medicine and family practice) who provide ambulatory care. Only providers who see patients in ambulatory care clinics will be included. Pediatric cardiologists and physicians who specialize primarily in adult congenital heart disease will be excluded from the study. Physicians who are approached will be required to provide written consent prior to participation in the study.

Once cardiologists and primary care physicians are recruited for the study, they will be randomized into one of two arms: 1) Intervention group, 2) Control group. Randomization will occur at the same time for each site to ensure the study start date is consistent across all sites.

Collection of TTE ordering information and TTE order classification:

A physician's TTE ordering information will be ascertained by review of the individual TTE order and by review of the patient's medical record. This may be through review of the Electronic Medical Record (EMR) or paper chart, depending on the individual site. Trained research coordinators at each site will review the TTE order for indication and review the patient record to ascertain clinical circumstances regarding the TTE order. The individual research coordinator will review this information using the 2011 AUC and classify the TTE as Appropriate (A), Inappropriate (I) or Uncertain (U), and assign the TTE order the most appropriate indication number accordingly. TTE orders that do not have a corresponding indication number will be designated as unclassifiable. Research Coordinators will be blinded to which physicians are in the intervention or control group. This system of TTE classification has been previously piloted and published by our group in two recently published studies, and the rate of successful classification was greater than 98%.

Dissemination of TTE monthly feedback reports:

Research Coordinators at each site will be responsible for individual physicians' TTE order classifications but will be blinded to study group. Once monthly TTE orders are classified and collated, this information will be transmitted to the central research laboratory, where a research coordinator will collate all of the results and transmit monthly feedback reports to individual physicians. This process ensures that local site coordinators and the study investigators are blinded to the results to the study, while still enabling the creation and dissemination of physician related feedback reports to the intervention group. The control group will order TTEs as is their usual practice.

Study Type

Interventional

Enrollment (Anticipated)

256

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • SunnyBrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network
      • Toronto, Ontario, Canada
        • Saint Michael's Hospital
      • Toronto, Ontario, Canada, M5S1B@
        • Women's College Hospital
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cardiologist or physician practicing Primary Care in the Ambulatory care

Exclusion Criteria:

  • . Pediatric cardiologists and physicians who specialize primarily in adult congenital heart disease will be excluded from the study

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education and Feedback Intervention

This intervention includes the following components:

  1. Formal Rounds on AUC for TTE:
  2. Appropriate Use for TTE Application for Smartphone
  3. Individualized Feedback Reports provided by email
Behavioral: Education and Feedback
  1. Formal Rounds on AUC for TTE
  2. Appropriate Use for TTE Application for Smartphone
  3. Individualized Feedback Reports provided by email
No Intervention: Control
Usual echocardiography ordering pratice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Inappropriate Transthoracic Echocardiograms ordered (%)
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Total Number of Transthoracic Echocardiograms Ordered per Physician
Time Frame: 18 months
18 months

Other Outcome Measures

Outcome Measure
Time Frame
Proportion of Appropriate Transthoracic Echocardiograms Ordered (%)
Time Frame: 18 months
18 months

Collaborators and Investigators

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

Sponsor

Women's College Hospital

Collaborators

University Health Network, Toronto
Sunnybrook Health Sciences Centre
Brigham and Women's Hospital
Unity Health Toronto
Queen's University
Mount Sinai Hospital, Canada
Scarborough General Hospital

Investigators

  • Principal Investigator: Sacha R Bhatia, MD, Women's College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Estimate)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 7, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCHTTE-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results will be published in an academic peer-reviewed journal.

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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