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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02038101
Recruitment Status : Unknown
Verified June 2016 by Women's College Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 16, 2014
Last Update Posted : June 9, 2016
Sponsor:
Collaborators:
University Health Network, Toronto
Unity Health Toronto
Sunnybrook Health Sciences Centre
Mount Sinai Hospital, Canada
Scarborough General Hospital
Kingston Health Sciences Centre
Brigham and Women's Hospital
Information provided by (Responsible Party):
Women's College Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
CARDIOVASCULAR DISEASES Behavioral: Education and Feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Feedback and Education Intervention to Reduce Inappropriate Transthoracic Echocardiograms (TTE)
Study Start Date : December 2014
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : August 2016

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.



Primary Outcome Measures :
  1. Proportion of Inappropriate Transthoracic Echocardiograms ordered (%) [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Total Number of Transthoracic Echocardiograms Ordered per Physician [ Time Frame: 18 months ]

Other Outcome Measures:
  1. Proportion of Appropriate Transthoracic Echocardiograms Ordered (%) [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038101


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Women's College Hospital
Toronto, Ontario, Canada, M5S1B@
Saint Michael's Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
Women's College Hospital
University Health Network, Toronto
Unity Health Toronto
Sunnybrook Health Sciences Centre
Mount Sinai Hospital, Canada
Scarborough General Hospital
Kingston Health Sciences Centre
Brigham and Women's Hospital
Investigators
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Principal Investigator: Sacha R Bhatia, MD Women's College Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT02038101    
Other Study ID Numbers: WCHTTE-001
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be published in an academic peer-reviewed journal.
Additional relevant MeSH terms:
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Cardiovascular Diseases