NCT02038101

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
256

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Dec 2014

Geographic Reach
2 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

1.4 years

First QC Date

January 14, 2014

Last Update Submit

June 7, 2016

Conditions

CARDIOVASCULAR DISEASES

Outcome Measures

Primary Outcomes (1)

  • Proportion of Inappropriate Transthoracic Echocardiograms ordered (%)

    18 months

Secondary Outcomes (1)

  • Total Number of Transthoracic Echocardiograms Ordered per Physician

    18 months

Other Outcomes (1)

  • Proportion of Appropriate Transthoracic Echocardiograms Ordered (%)

    18 months

Study Arms (2)

Education and Feedback Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual echocardiography ordering pratice.

Interventions

Education and FeedbackBEHAVIORAL

1. Formal Rounds on AUC for TTE 2. Appropriate Use for TTE Application for Smartphone 3. Individualized Feedback Reports provided by email

Education and Feedback Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiologist or physician practicing Primary Care in the Ambulatory care

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S1B@, Canada

Location

Saint Michael's Hospital

Toronto, Ontario, Canada

Location

Related Publications (7)

  • Bhatia RS, Milford CE, Picard MH, Weiner RB. An educational intervention reduces the rate of inappropriate echocardiograms on an inpatient medical service. JACC Cardiovasc Imaging. 2013 May;6(5):545-55. doi: 10.1016/j.jcmg.2013.01.010. Epub 2013 Apr 10.

    PMID: 23582360BACKGROUND

  • Blecker S, Bhatia RS, You JJ, Lee DS, Alter DA, Wang JT, Wong HJ, Tu JV. Temporal trends in the utilization of echocardiography in Ontario, 2001 to 2009. JACC Cardiovasc Imaging. 2013 Apr;6(4):515-22. doi: 10.1016/j.jcmg.2012.10.026.

    PMID: 23579013BACKGROUND

  • Bhatia RS, Carne DM, Picard MH, Weiner RB. Comparison of the 2007 and 2011 appropriate use criteria for transthoracic echocardiography in various clinical settings. J Am Soc Echocardiogr. 2012 Nov;25(11):1162-9. doi: 10.1016/j.echo.2012.07.018. Epub 2012 Aug 14.

    PMID: 22898245BACKGROUND

  • Tharmaratnam T, Bouck Z, Sivaswamy A, Wijeysundera HC, Chu C, Yin CX, Nesbitt GC, Edwards J, Yared K, Wong B, Weinerman A, Thavendiranathan P, Rakowski H, Dorian P, Anderson G, Austin PC, Dudzinski DM, Ko DT, Weiner RB, Bhatia RS. Association Between Physicians' Appropriate Use of Echocardiography and Subsequent Healthcare Use and Outcomes in Patients With Heart Failure. J Am Heart Assoc. 2020 Jan 7;9(1):e013360. doi: 10.1161/JAHA.119.013360. Epub 2019 Dec 24.

    PMID: 31870231DERIVED

  • Tharmaratnam T, Bouck Z, Sivaswamy A, Wijeysundera HC, Chu C, Yin CX, Nesbitt GC, Edwards J, Yared K, Wong B, Weinerman A, Thavendiranathan P, Rakowski H, Dorian P, Anderson G, Austin PC, Dudzinski DM, Ko DT, Weiner RB, Bhatia RS. Low-Value Transthoracic Echocardiography, Healthcare Utilization, and Clinical Outcomes in Patients With Coronary Artery Disease. Circ Cardiovasc Qual Outcomes. 2019 Nov;12(11):e006123. doi: 10.1161/CIRCOUTCOMES.119.006123. Epub 2019 Nov 11.

    PMID: 31707824DERIVED

  • Bhatia RS, Ivers NM, Yin XC, Myers D, Nesbitt GC, Edwards J, Yared K, Wadhera RK, Wu JC, Kithcart AP, Wong BM, Hansen MS, Weinerman AS, Shadowitz S, Elman D, Farkouh ME, Thavendiranathan P, Udell JA, Johri AM, Chow CM, Hall J, Bouck Z, Cohen A, Thorpe KE, Rakowski H, Picard MH, Weiner RB. Improving the Appropriate Use of Transthoracic Echocardiography: The Echo WISELY Trial. J Am Coll Cardiol. 2017 Aug 29;70(9):1135-1144. doi: 10.1016/j.jacc.2017.06.065.

    PMID: 28838362DERIVED

  • Bhatia RS, Ivers N, Yin CX, Myers D, Nesbitt G, Edwards J, Yared K, Wadhera R, Wu JC, Wong B, Hansen M, Weinerman A, Shadowitz S, Johri A, Farkouh M, Thavendiranathan P, Udell JA, Rambihar S, Chow CM, Hall J, Thorpe KE, Rakowski H, Weiner RB. Design and methods of the Echo WISELY (Will Inappropriate Scenarios for Echocardiography Lessen SignificantlY) study: An investigator-blinded randomized controlled trial of education and feedback intervention to reduce inappropriate echocardiograms. Am Heart J. 2015 Aug;170(2):202-9. doi: 10.1016/j.ahj.2015.04.022. Epub 2015 May 1.

    PMID: 26299215DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Sacha R Bhatia, MD

    Women's College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 16, 2014

Study Start

December 1, 2014

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

June 9, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

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

Locations

CA(5)US(1)