Pulmonary EmbolismNCT02283086
Effects of Performance Feedback on Imaging Use in the Emergency Department
A study testing Physician Feedback Reporting in people with Pulmonary Embolism, run by Brigham and Women's Hospital.
Trial summary
DESIGN: An IRB-approved, HIPAA-compliant prospective randomized controlled trial conducted from January 1, 2012-December 31, 2013. SETTING: The ED of an urban Level-I adult trauma center with existing CDS for CTPE. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Physician Feedback Reporting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All attending physicians in the emergency department
Who cannot join
- None
About this study
DESIGN: An IRB-approved, HIPAA-compliant prospective randomized controlled trial conducted from January 1, 2012-December 31, 2013.
SETTING: The ED of an urban Level-I adult trauma center with existing CDS for CTPE.
PARTICIPANTS: All attending physicians were stratified into quartiles by 2012 CTPE use and randomized to receive feedback reporting or not.
INTERVENTION: Quarterly performance feedback reports consisting of individual and anonymized group data on EBG adherence (using the Wells criteria), CTPE use (CTPEs per 1,000 patients), and yield (percentage of CTPEs positive for PE) beginning January 2013.
Read the detailed description
Setting and Subjects This IRB-approved and HIPAA-compliant prospective randomized controlled trial was conducted from January 1, 2012 to December 31, 2013 in the ED of an urban Level-I adult trauma center. Imaging CDS was deployed for all CTPE requests throughout the study period as previously reported. Ordering providers could ignore the evidence presented in CDS and proceed with CTPE requests deviating from evidence-based guidelines without interference. The investigators included all attending emergency physicians and, prior to randomization, stratified them into quartiles by 2012 CTPE use. Physicians were randomized by quartile into two groups using a random number generator: the intervention group received individualized feedback reports on CTPE adherence to EBG, use (defined as number of CTPEs per 1,000 patients), and yield (percentage of CTPEs positive for PE), and the control group did not.
Data Collection Use of CTPEs for each physician was calculated using the number of completed CTPE examinations and the total number of patients seen during the quarter. Yield of CTPEs for acute PE was determined using a previously validated natural language processing tool and reported as a percentage of total CTPEs completed. Adherence to EBG was determined by applying the Wells Criteria and reviewing the serum D-dimer levels (if obtained). The discrete criteria making up the Wells Criteria were prospectively documented in the investigators computerized order entry (CPOE) system at the time of order entry, as previously reported.
In order to determine whether any differences observed in guideline adherence were the result of "gaming" (erroneous data entry to either avoid potentially onerous CDS interactions or to enhancing the physician's apparent performance on feedback reports) the investigators performed manual chart reviews of 100 randomly chosen charts from each of the two groups. These chart reviews were performed by an attending physician to assess concordance between adherence to EBG calculated from the CDS data, and adherence to EBG calculated from data documented in the ED visit clinical note. The sample size was determined using a baseline concordance of 90% as previously reported, and chosen to detect a difference in concordance of 15% between groups with a power of 80% and an alpha error rate of 5%. Demographic data (including gender and both age and years since residency training as measured at the beginning of the study period) was also captured for all the attending physicians in the study.
- Conditions
- Pulmonary Embolism
- Being tested
- Physician Feedback Reporting
- Keywords
- Quality Improvement, Physician Feedback
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician Feedback ReportingBehavioural
The performance feedback reports displayed both individual physicians' statistics as well as their performance compared to anonymized results for the entire group of emergency physicians.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | The intervention consisted of quarterly performance feedback reports sent via e-mail. Receives: Behavioral: Physician Feedback Reporting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Evidence-Based Guidelines
Percentage of CTPE orders that adhere to evidence-based guidelines for the ordering of CTs for PE
Measured: 2 years
Secondary outcomes (2)
Use of Computed Tomography for Pulmonary Embolism
#CTPEs/1,000 ED visits for each physician
Measured: 2 years
Yield of Computed Tomography for Pulmonary Embolism
Percentage of CTPE orders that are positive for acute PE
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramin Khorasani, M.D.,M.P.H., Brigham and Women's Hospital
- Investigators
- Ramin Khorasani, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283086
- Sponsor's protocol ID
- 2009-P001587
- Status last verified
- Nov 2014
- First submitted
- 2 Nov 2014
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Performance Feedback on Imaging Use in the Emergency Department
- ClinicalTrials.gov ID
- NCT02283086
- Acronym / sponsor ID
- 2009-P001587
- Conditions
- Pulmonary Embolism
- Keywords
- Quality Improvement, Physician Feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Nov 2014 (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.
DESIGN: An IRB-approved, HIPAA-compliant prospective randomized controlled trial conducted from January 1, 2012-December 31, 2013.
SETTING: The ED of an urban Level-I adult trauma center with existing CDS for CTPE.
PARTICIPANTS: All attending physicians were stratified into quartiles by 2012 CTPE use and randomized to receive feedback reporting or not.
INTERVENTION: Quarterly performance feedback reports consisting of individual and anonymized group data on EBG adherence (using the Wells criteria), CTPE use (CTPEs per 1,000 patients), and yield (percentage of CTPEs positive for PE) beginning January 2013.
Detailed description
Setting and Subjects This IRB-approved and HIPAA-compliant prospective randomized controlled trial was conducted from January 1, 2012 to December 31, 2013 in the ED of an urban Level-I adult trauma center. Imaging CDS was deployed for all CTPE requests throughout the study period as previously reported. Ordering providers could ignore the evidence presented in CDS and proceed with CTPE requests deviating from evidence-based guidelines without interference. The investigators included all attending emergency physicians and, prior to randomization, stratified them into quartiles by 2012 CTPE use. Physicians were randomized by quartile into two groups using a random number generator: the intervention group received individualized feedback reports on CTPE adherence to EBG, use (defined as number of CTPEs per 1,000 patients), and yield (percentage of CTPEs positive for PE), and the control group did not.
Data Collection Use of CTPEs for each physician was calculated using the number of completed CTPE examinations and the total number of patients seen during the quarter. Yield of CTPEs for acute PE was determined using a previously validated natural language processing tool and reported as a percentage of total CTPEs completed. Adherence to EBG was determined by applying the Wells Criteria and reviewing the serum D-dimer levels (if obtained). The discrete criteria making up the Wells Criteria were prospectively documented in the investigators computerized order entry (CPOE) system at the time of order entry, as previously reported.
In order to determine whether any differences observed in guideline adherence were the result of "gaming" (erroneous data entry to either avoid potentially onerous CDS interactions or to enhancing the physician's apparent performance on feedback reports) the investigators performed manual chart reviews of 100 randomly chosen charts from each of the two groups. These chart reviews were performed by an attending physician to assess concordance between adherence to EBG calculated from the CDS data, and adherence to EBG calculated from data documented in the ED visit clinical note. The sample size was determined using a baseline concordance of 90% as previously reported, and chosen to detect a difference in concordance of 15% between groups with a power of 80% and an alpha error rate of 5%. Demographic data (including gender and both age and years since residency training as measured at the beginning of the study period) was also captured for all the attending physicians in the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Behavioral: Physician Feedback ReportingThe intervention consisted of quarterly performance feedback reports sent via e-mail. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All attending physicians in the emergency department
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Physician Feedback ReportingThe performance feedback reports displayed both individual physicians' statistics as well as their performance compared to anonymized results for the entire group of emergency physicians. | Behavioural | Intervention |
Primary outcome
Adherence to Evidence-Based Guidelines
Time frame: 2 years
Percentage of CTPE orders that adhere to evidence-based guidelines for the ordering of CTs for PE
2 secondary outcomes
Use of Computed Tomography for Pulmonary Embolism
Time frame: 2 years
Yield of Computed Tomography for Pulmonary Embolism
Time frame: 2 years
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 5 Nov 2014.
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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.
Ramin Khorasani, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Physician Feedback Reporting in people with Pulmonary Embolism, run by Brigham and Women's Hospital.
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 1 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 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Adherence to Evidence-Based Guidelines (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2014.