Inappropriate Use of EchocardiographyNCT01944202
Educational Intervention to Reduce Outpatient Inappropriate Transthoracic Echocardiograms
A study testing Educational intervention in people with Inappropriate Use of Echocardiography, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inappropriate Use of Echocardiography
- 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
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to May 2013
- 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
- Cardiovascular Medicine fellows at Massachusetts General Hospital
- Internal Medicine residents at Massachusetts General Hospital
Who cannot join
- Attending physicians
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Inappropriate Use of Echocardiography
- Being tested
- Educational intervention
- Keywords
- Echocardiography, Appropriate Use Criteria, Educational Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionBehavioural
Educational and feedback intervention, as described in the Arm Description.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention | Experimental | 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. Receives: Behavioral: Educational intervention |
| Control group | No intervention | Physicians in the control arm have their TTE orders tracked and classified, but do 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: 9 months
Secondary outcomes (1)
Rate of Appropriate Transthoracic Echocardiograms
Rate of appropriate transthoracic echocardiograms determined from a review of the electronic medical record.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inappropriate Use of EchocardiographyStudies 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
- 112 participants (actual)
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
- NCT01944202
- Sponsor's protocol ID
- 2011P001779CR1
- Status last verified
- Sep 2013
- First submitted
- 10 Sep 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bhatia RS, Dudzinski DM, Malhotra R, Milford CE, Yoerger Sanborn DM, Picard MH, Weiner RB. Educational intervention to reduce outpatient inappropriate echocardiograms: a randomized control trial. JACC Cardiovasc Imaging. 2014 Sep;7(9):857-66. doi: 10.1016/j.jcmg.2014.04.014. Epub 2014 Aug 13.
PubMed 25129520
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Outpatient Inappropriate Transthoracic Echocardiograms With An Educational Intervention: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01944202
- Acronym / sponsor ID
- 2011P001779CR1
- Conditions
- Inappropriate Use of Echocardiography
- Keywords
- Echocardiography, Appropriate Use Criteria, Educational Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 17 Sep 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.
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.
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 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 interventionPhysicians 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. |
| Control group | No intervention | –Physicians in the control arm have their TTE orders tracked and classified, but do 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)
- Cardiovascular Medicine fellows at Massachusetts General Hospital
- Internal Medicine residents at Massachusetts General Hospital
Key exclusion criteria (1 listed)
- Attending physicians
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 interventionEducational and feedback intervention, as described in the Arm Description. | Behavioural | Educational Intervention |
Primary outcome
Rate of Inappropriate transthoracic echocardiograms
Time frame: 9 months
Rate of inappropriate echocardiograms determined from a review of the electronic medical record.
1 secondary outcome
Rate of Appropriate Transthoracic Echocardiograms
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
- Derived from this study: PubMed 25129520Bhatia RS, Dudzinski DM, Malhotra R, Milford CE, Yoerger Sanborn DM, Picard MH, Weiner RB. Educational intervention to reduce outpatient inappropriate echocardiograms: a randomized control trial. JACC Cardiovasc Imaging. 2014 Sep;7(9):857-66. doi: 10.1016/j.jcmg.2014.04.014. Epub 2014 Aug 13.
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 Use of Echocardiography, 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: finished, as of the sponsor's last update on 17 Sep 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Inappropriate transthoracic echocardiograms (time frame: 9 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 NCT01944202, which also lists 1 linked publication.
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 17 Sep 2013.