Educational Intervention to Reduce Outpatient Inappropriate Transthoracic Echocardiograms

September 12, 2013 updated by: Rory Weiner, MD, Massachusetts General Hospital

Reducing Outpatient Inappropriate Transthoracic Echocardiograms With An Educational Intervention: A Randomized Control Trial

It is well documented that the proportion of inappropriate transthoracic echocardiograms (TTEs) is highest in the ambulatory environment, where it has been reported as high as 30%. Therefore, the potential to improve TTE utilization may be greatest in the outpatient setting. However, no study to date has evaluated whether an Appropriate Use Criteria (AUC)-based educational intervention can reduce inappropriate TTEs in this setting. The investigators therefore designed the first randomized control trial of an AUC-based educational and feedback intervention aimed at reducing inappropriate outpatient TTEs ordered by cardiology and internal medicine physicians in training.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators designed a randomized, control trial of an AUC-based educational and feedback intervention designed to reduce the proportion of inappropriate TTEs in the cardiology and internal medicine outpatient practices at Massachusetts General Hospital. A random number generator divided 24 cardiology fellows and 88 internal medicine residents into control and intervention arms.

During the study, physicians in the intervention arm receive the following multi-faceted educational intervention on TTE appropriateness: 1) a lecture at the beginning of the study period, which describes the AUC for echocardiography and highlights common clinical scenarios for which outpatient TTEs are ordered, 2) an electronic "pocket card" via email that provides tips on appropriate ordering of TTEs, and 3) an individualized monthly feedback report that categorizes TTEs ordered over the preceding month. The feedback reports contain the number of TTEs ordered during the month and how many are classified as appropriate, inappropriate, or uncertain based on the 2011 AUC. A description of all inappropriate TTEs and the rationale for the inappropriate classification is provided. The physicians in the control arm have their TTE orders tracked and classified, but do not receive any feedback on their ordering behavior. While study participants are not blinded to which arm of the study they are in, they were blinded to which arm of the study their colleagues are in.

Prior to the start of the intervention, all study participants receive a knowledge assessment survey. The survey includes five case-based questions designed to assess knowledge of the AUC for TTE and also questions regarding attitudes toward diagnostic testing. Each participant also receives a post-study knowledge assessment survey.

The primary outcome measures in this study are the rate of inappropriate and appropriate TTEs. Secondary outcome measures include the number of TTEs ordered, common appropriate and inappropriate TTE indications, and pre- and post-study knowledge assessment scores among the study physicians.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cardiovascular Medicine fellows at Massachusetts General Hospital
  • Internal Medicine residents at Massachusetts General Hospital

Exclusion Criteria:

  • Attending physicians

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Educational Intervention
Physicians in the intervention arm receive the following multi-faceted educational intervention on transthoracic echocardiogram appropriateness: 1) a lecture at the beginning of the study period, which describes the Appropriate Use Criteria (AUC) for echocardiography and highlights common clinical scenarios for which outpatient TTEs are ordered, 2) an electronic "pocket card" via email that provides tips on appropriate ordering of TTEs, and 3) an individualized monthly feedback report that categorized TTEs ordered over the preceding month. The feedback reports contains the number of TTEs ordered during the month and how many are classified as appropriate, inappropriate, or uncertain based on the 2011 AUC.
Behavioral: Educational intervention
Educational and feedback intervention, as described in the Arm Description.
No Intervention: Control group
Physicians in the control arm have their TTE orders tracked and classified, but do not receive any feedback on their ordering behavior.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Inappropriate transthoracic echocardiograms
Time Frame: 9 months
Rate of inappropriate echocardiograms determined from a review of the electronic medical record.
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Appropriate Transthoracic Echocardiograms
Time Frame: 9 months
Rate of appropriate transthoracic echocardiograms determined from a review of the electronic medical record.
9 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical reasons for appropriate and inappropriate transthoracic echocardiograms
Time Frame: 9 months
All echocardiograms will be classifed according to the Appropriate Use Criteria (AUC). This will allow for determination of the most common clinical indications for both appropriate and inappopriate TTEs.
9 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rory B Weiner, MD, Massachusetts General 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011P001779CR1

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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