Inappropriate and Appropriate Transthoracic EchocardiogramsNCT01968642
Education and Feedback Intervention to Reduce Inappropriate Transthoracic Echocardiograms
A study testing Educational Intervention in people with Inappropriate and Appropriate Transthoracic Echocardiograms, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The utilization of transthoracic echocardiography in the United States has been increasing. This has resulted in increased costs to the healthcare system. In an effort to curb excessive utilization of this technology, the American College of Cardiology created Appropriate Use Criteria to help guide clinicians to use… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inappropriate and Appropriate Transthoracic Echocardiograms
- What is being tested?
- Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cardiology Attending physicians at Massachusetts General Hospital
- Primary care physicians at Massachusetts General Hospital
Who cannot join
- Physicians-in-training
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Rory B Weiner, MD, 617-724-0358, rweiner@partners.org
Rory B Weiner, MD
About this study
Official title: Educational Intervention to Reduce Outpatient Inappropriate Transthoracic Echocardiograms Ordered by Attending Physicians
The utilization of transthoracic echocardiography in the United States has been increasing. This has resulted in increased costs to the healthcare system. In an effort to curb excessive utilization of this technology, the American College of Cardiology created Appropriate Use Criteria to help guide clinicians to use this diagnostic imaging modality more appropriately. The investigators previously showed that an educational intervention can reduce the rate of inappropriate echocardiograms ordered by physicians-in-training. It is unknown if such an intervention would be successful in attending, staff level of physicians. The investigators hypothesize that an educational and feedback intervention will reduce the rate of inappropriate outpatient transthoracic echocardiograms ordered by staff cardiologists and internal medicine physicians.
Read the detailed description
In response to increasing utilization of echocardiography, the American Society of Echocardiography along with the American College of Cardiology released Appropriate Use Criteria (AUC) for transthoracic echocardiography (TTE) in 2007, and these have been subsequently updated in 2011. TTE ordering patterns have been evaluated and have shown that between 15-30% of TTE ordered are inappropriate. The highest rate of inappropriate TTE is found in the outpatient environment, where routine or "surveillance" studies are common. These studies have also found that internists and cardiologists order the majority of TTE. The investigators previously documented that an AUC-based educational and feedback intervention reduced the rate of inappropriate TTE by cardiology and internal medicine physicians-in-training. Whether this type of intervention can improve TTE ordering of attending level physicians is not known.
- Being tested
- Educational Intervention
- Keywords
- Transthoracic echocardiograms, Appropriate Use Criteria, Medical Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention | Experimental | Attending physicians in the intervention arm will receive the following multi-faceted educational intervention on transthoracic echocardiogram appropriateness: 1) a lecture at the beginning of the study period, which describes Appropriate USe Criteria (AUC) and highlights common clinical scenarios for which outpatient echocardiograms are ordered, 2) an electronic "pocket cared" via email that provides tips on appropriate ordering of echocardiograms, and 3) an individualized monthly feedback report that categorizes echocardiograms ordered over the preceding month. The feedback report will contain the number of echocardiograms ordered during the month and how many are classified as appropriate, inappropriate, or uncertain based on the 2011 AUC. Receives: Behavioral: Educational Intervention |
| Control Group | No intervention | Attending physicians in the control arm will have their echocardiogram orders tracked and classified, but will not receive any feedback on their ordering behavior. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Inappropriate transthoracic echocardiograms
Rate of inappropriate echocardiograms determined from a review of the electronic medical record.
Measured: 12 months
Secondary outcomes (1)
Rate of Appropriate transthoracic echocardiograms
Rate of appropriate transthoracic echocardiograms determined from a review of the electronic medical record.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inappropriate and Appropriate Transthoracic EchocardiogramsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rory Weiner, MD, Massachusetts General Hospital
- Investigators
- Rory B Weiner, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968642
- Sponsor's protocol ID
- 2011P001779 AME3
- Status last verified
- Feb 2014
- First submitted
- 20 Oct 2013
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23582360Dudzinski DM, Bhatia RS, Mi MY, Isselbacher EM, Picard MH, Weiner RB. Effect of Educational Intervention on the Rate of Rarely Appropriate Outpatient Echocardiograms Ordered by Attending Academic Cardiologists: A Randomized Clinical Trial. JAMA Cardiol. 2016 Oct 1;1(7):805-812. doi: 10.1001/jamacardio.2016.2232.
PubMed 27547895
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention to Reduce Outpatient Inappropriate Transthoracic Echocardiograms Ordered by Attending Physicians
- ClinicalTrials.gov ID
- NCT01968642
- Acronym / sponsor ID
- 2011P001779 AME3
- Keywords
- Transthoracic echocardiograms, Appropriate Use Criteria, Medical Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The utilization of transthoracic echocardiography in the United States has been increasing. This has resulted in increased costs to the healthcare system. In an effort to curb excessive utilization of this technology, the American College of Cardiology created Appropriate Use Criteria to help guide clinicians to use this diagnostic imaging modality more appropriately. The investigators previously showed that an educational intervention can reduce the rate of inappropriate echocardiograms ordered by physicians-in-training. It is unknown if such an intervention would be successful in attending, staff level of physicians. The investigators hypothesize that an educational and feedback intervention will reduce the rate of inappropriate outpatient transthoracic echocardiograms ordered by staff cardiologists and internal medicine physicians.
Detailed description
In response to increasing utilization of echocardiography, the American Society of Echocardiography along with the American College of Cardiology released Appropriate Use Criteria (AUC) for transthoracic echocardiography (TTE) in 2007, and these have been subsequently updated in 2011. TTE ordering patterns have been evaluated and have shown that between 15-30% of TTE ordered are inappropriate. The highest rate of inappropriate TTE is found in the outpatient environment, where routine or "surveillance" studies are common. These studies have also found that internists and cardiologists order the majority of TTE. The investigators previously documented that an AUC-based educational and feedback intervention reduced the rate of inappropriate TTE by cardiology and internal medicine physicians-in-training. Whether this type of intervention can improve TTE ordering of attending level physicians is not known.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention | Experimental | Behavioral: Educational InterventionAttending physicians in the intervention arm will receive the following multi-faceted educational intervention on transthoracic echocardiogram appropriateness: 1) a lecture at the beginning of the study period, which describes Appropriate USe Criteria (AUC) and highlights common clinical scenarios for which outpatient echocardiograms are ordered, 2) an electronic "pocket cared" via email that provides tips on appropriate ordering of echocardiograms, and 3) an individualized monthly feedback report that categorizes echocardiograms ordered over the preceding month. The feedback report will contain the number of echocardiograms ordered during the month and how many are classified as appropriate, inappropriate, or uncertain based on the 2011 AUC. |
| Control Group | No intervention | –Attending physicians in the control arm will have their echocardiogram orders tracked and classified, but will not receive any feedback on their ordering behavior. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Cardiology Attending physicians at Massachusetts General Hospital
- Primary care physicians at Massachusetts General Hospital
Key exclusion criteria (1 listed)
- Physicians-in-training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Intervention | Behavioural | Educational Intervention |
Primary outcome
Rate of Inappropriate transthoracic echocardiograms
Time frame: 12 months
Rate of inappropriate echocardiograms determined from a review of the electronic medical record.
1 secondary outcome
Rate of Appropriate transthoracic echocardiograms
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
- Background: PubMed 23582360Bhatia 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.
- Derived from this study: PubMed 27547895Dudzinski DM, Bhatia RS, Mi MY, Isselbacher EM, Picard MH, Weiner RB. Effect of Educational Intervention on the Rate of Rarely Appropriate Outpatient Echocardiograms Ordered by Attending Academic Cardiologists: A Randomized Clinical Trial. JAMA Cardiol. 2016 Oct 1;1(7):805-812. doi: 10.1001/jamacardio.2016.2232.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rory B Weiner, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Inappropriate and Appropriate Transthoracic Echocardiograms, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rory B Weiner, MD (617-724-0358, rweiner@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Inappropriate transthoracic echocardiograms (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01968642, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.